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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-003163-20 | EudraCT Number |
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| Name | Class |
|---|---|
| Foundation Medicine | INDUSTRY |
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The purpose of this study is to determine how participants with metastatic castration-resistant prostate cancer, and evidence of a homologous recombination gene deficiency, respond to treatment with rucaparib versus treatment with physician's choice of abiraterone acetate, enzalutamide, or docetaxel.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rucaparib | Experimental | Oral rucaparib (monotherapy). |
|
| Abiraterone acetate or Enzalutamide or Docetaxel | Active Comparator | Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rucaparib | Drug | Rucaparib will be administered daily. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic Progression-free Survival (rPFS) by IRR in Participants With a BRCA Alteration | The primary efficacy endpoint for the study is rPFSirr, defined as the time from randomization to the first objective evidence of radiographic progression, or death due to any cause (whichever occurs first). Radiographic disease progression includes confirmed soft tissue disease progression and confirmed bone disease progression as per modified RECIST Version 1.1 (at least a 20% increase in the sum of the LD of target lesions or appearance of one or more new extra-skeletal lesions and/or unequivocal progression of existing nontarget lesions) or PCWG3 criteria Progression by bone is determined by PCWG3 criteria in which at least two new lesions appearing during the first 12-week flare window followed by 2 additional new lesions in the confirmatory scan appearing after the 12-week flare window, or after the 12-week flare window, at least 2 new lesions relative to the first post-treatment scan confirmed on a subsequent scan). | From enrollment to primary completion of study (Total follow-up was up to approximately 4 years) |
| Radiographic Progression-free Survival (rPFS) by IRR in Participants With a BRCA or ATM Alteration Combined | The primary efficacy endpoint for the study is rPFSirr, defined as the time from randomization to the first objective evidence of radiographic progression, or death due to any cause (whichever occurs first). Radiographic disease progression includes confirmed soft tissue disease progression and confirmed bone disease progression as per modified RECIST Version 1.1 (at least a 20% increase in the sum of the LD of target lesions or appearance of one or more new extra-skeletal lesions and/or unequivocal progression of existing nontarget lesions) or PCWG3 criteria (Progression by bone is determined by PCWG3 criteria in which at least two new lesions appearing during the first 12-week flare window followed by 2 additional new lesions in the confirmatory scan appearing after the 12-week flare window, or after the 12-week flare window, at least 2 new lesions relative to the first post-treatment scan confirmed on a subsequent scan). | From enrollment to primary completion of study (Total follow-up was up to approximately 4 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival in Participants With a BRCA Alteration | Overall survival time is calculated as the time from randomization to death (by any cause) +1 day. Participants who have not died will be censored on the date the participant was last known to be alive. | From enrollment to completion of study (up to approximately 7 years) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
| Mayo Clinic - Arizona |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36795891 | Result | Fizazi K, Piulats JM, Reaume MN, Ostler P, McDermott R, Gingerich JR, Pintus E, Sridhar SS, Bambury RM, Emmenegger U, Lindberg H, Morris D, Nole F, Staffurth J, Redfern C, Saez MI, Abida W, Daugaard G, Heidenreich A, Krieger L, Sautois B, Loehr A, Despain D, Heyes CA, Watkins SP, Chowdhury S, Ryan CJ, Bryce AH; TRITON3 Investigators. Rucaparib or Physician's Choice in Metastatic Prostate Cancer. N Engl J Med. 2023 Feb 23;388(8):719-732. doi: 10.1056/NEJMoa2214676. Epub 2023 Feb 16. | |
| 36898948 |
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De-identified datasets for study results will be made available to qualified researchers in compliance with applicable privacy laws and data protection regulations.
Data will be provided by pharmaand GmbH.
Data will be made available to qualified researchers after the primary, secondary, and/or exploratory outcomes of the study are reported or published and for 1 year thereafter.
Requests for de-identified datasets will be made available to qualified researchers following submission of a methodologically sound proposal to medinfo@pharmaand.com.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rucaparib | Oral rucaparib (monotherapy). Rucaparib: Rucaparib will be administered daily. |
| FG001 | Abiraterone Acetate or Enzalutamide or Docetaxel | Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone). Abiraterone acetate or Enzalutamide or Docetaxel: Abiraterone acetate and enzalutamide will be administered daily. Docetaxel will be administered every 3 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Phase |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 18, 2022 | Jun 2, 2023 |
Not provided
Not provided
Not provided
Not provided
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| Abiraterone acetate or Enzalutamide or Docetaxel | Drug | Abiraterone acetate and enzalutamide will be administered daily. Docetaxel will be administered every 3 weeks. |
|
|
| Overall Survival in Participants With a BRCA or ATM Alteration Combined |
Overall survival time is calculated as the time from randomization to death (by any cause) +1 day. Participants who have not died will be censored on the date the participants was last known to be alive. |
| From enrollment to completion of study (up to approximately 7 years) |
| Objective Response Rate (ORR) by IRR in Participants With a BRCA Alteration | ORR is defined as the percentage of participants with a confirmed best response of Complete response (CR) or Partial Response (PR) in participants with measurable disease at study entry. Modified RECIST Version 1.1 criteria is used to determine ORR (ie, CR or PR by IRR assessment and no progression in bone per PCWG3 by IRR assessment). CR is disappearance of all target and non-target lesions; any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. | From enrollment to primary completion of study (Total follow-up was up to approximately 4 years) |
| Objective Response Rate (ORR) by IRR in Participants With a BRCA or ATM Alteration Combined | ORR is defined as the percentage of participants with a confirmed best response of Complete response (CR) or Partial Response (PR) in participants with measurable disease at study entry. Modified RECIST Version 1.1 criteria is used to determine ORR (ie, CR or PR by IRR assessment and no progression in bone per PCWG3 by IRR assessment). CR is disappearance of all target and non-target lesions; any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. | From enrollment to primary completion of study (Total follow-up was up to approximately 4 years) |
| Duration of Response (DOR) by IRR in Participants With a BRCA Alteration | DOR is defined as the time from the first confirmed response (CR or PR by modified RECIST Version 1.1 in participants with nodal or visceral ± nodal disease) until the first date that Progressive Disease (PD) (using the same criteria) is documented. | From enrollment to primary completion of study (Total follow-up was up to approximately 4 years) |
| Duration of Response (DOR) by IRR in Participants With a BRCA or ATM Alteration Combined | DOR is defined as the time from the first confirmed response (CR or PR by modified RECIST Version 1.1 in participants with nodal or visceral ± nodal disease) until the first date that Progressive Disease (PD) (using the same criteria) is documented. | From enrollment to primary completion of study (Total follow-up was up to approximately 4 years) |
| PSA Response in Participants With a BRCA Alteration | Confirmed PSA response is defined as ≥ 50% reduction in PSA from baseline on at least two assessments conducted at least 3 weeks apart. PSA response is calculated for all participants with PSA values at baseline and at least one post-baseline assessment. PSA is assessed by a local laboratory. | From enrollment to primary completion of study (up to approximately 5 years) |
| PSA Response in Participants With a BRCA or ATM Alteration Combined | Confirmed PSA response is defined as ≥ 50% reduction in PSA from baseline on at least two assessments conducted at least 3 weeks apart. PSA response is calculated for all participants with PSA values at baseline and at least one post-baseline assessment. PSA is assessed by a local laboratory. | From enrollment to primary completion of study (up to approximately 5 years) |
| Clinical Benefit Rate (CBR) by IRR at 6 Months in Participants With a BRCA Alteration | Defined as the percentage of participants with a complete response (CR), partial response (PR), and stable disease (SD) according to modified RECIST Version 1.1 with no progression in bone per PCWG3 criteria. | From enrollment to 6 months |
| Clinical Benefit Rate (CBR) by IRR at 6 Months in Participants With a BRCA or ATM Alteration Combined | Defined as the percentage of participants with a Complete Response (CR), Partial Response (PR), and Stable Disease (SD), according to Modified RECIST Version 1.1 with no progression in bone per PCWG3 Criteria. | From enrollment to 6 months |
| Time to Prostate Specific Antigen (PSA) Progression in Participants With a BRCA Alteration | Time to PSA progression is defined as the time from randomization to the date that a ≥ 25% increase and absolute increase of ≥ 2 ng/mL above the nadir (or baseline value for participants who did not have a decline in PSA) in PSA was measured. The increase must be confirmed by a second consecutive assessment conducted at least 3 weeks later. | From enrollment to primary completion of study (up to approximately 5 years) |
| Time to Prostate Specific Antigen (PSA) Progression in Participants With a BRCA or ATM Alteration Combined | Time to PSA progression is defined as the time from randomization to the date that a ≥ 25% increase and absolute increase of ≥ 2 ng/mL above the nadir (or baseline value for participants who did not have a decline in PSA) in PSA was measured. The increase must be confirmed by a second consecutive assessment conducted at least 3 weeks later. | From enrollment to primary completion of study (up to approximately 5 years) |
| Change in Patient-reported Outcome (PRO) in Participants With a BRCA Alteration: FACT-P | Changes in health and pain status from baseline to week 25 using: Functional Assessment of Cancer Therapy-Prostate questionnaire (FACT-P total score, on a scale of 0 to 156 where a higher score is better quality of life). The greater the decrease in score (ie more negative) from baseline to week 25 the greater the decrease in health status. Assessments completed during screening, at study treatment visits (Day 1, Day 15, Day 29, Day 43, Day 57, and every 29 days thereafter) (during the Treatment Phase, the Treatment Discontinuation Visit, and during the Follow-up Phase. | From enrollment to up to approximately 25 weeks |
| Change in Patient-reported Outcome (PRO) in Participants With a BRCA Alteration: BPI-SF | Changes in health and pain status from baseline to week 25 using: Brief Pain Inventory-Short Form (BPI-SF) questionnaire (on a scale of 1 to 10, from mild to severe, for pain and pain-interference scores). A decrease indicates less severe pain/interference. Assessments completed during screening, at study treatment visits (Day 1, Day 15, Day 29, Day 43, Day 57, and every 29 days thereafter) (during the Treatment Phase, the Treatment Discontinuation Visit, and during the Follow-up Phase. | From enrollment to up to approximately 25 weeks |
| Change in Patient-reported Outcome (PRO) in Participants With a BRCA Alteration: EQ-5D-5L | Changes in health and pain status from baseline to week 25 using: EuroQol-5D-5L Visual Analogue Scale (EQ-5D-5L VAS; on a scale from 100 to 0, from best to worst health status). The greater the increase in score (including more negative) from baseline to week 25 the greater the increase in health status. Assessments completed during screening, at study treatment visits (Day 1, Day 15, Day 29, Day 43, Day 57, and every 29 days thereafter) during the Treatment Phase, the Treatment Discontinuation Visit, and during the Follow-up Phase. | From enrollment to up to approximately 25 weeks |
| Trough Plasma PK (Cmin) of Rucaparib Based on Sparse Sampling | Mean trough PK plasma concentration over time in the safety population with at least one PK sample collected at timepoints week 5, 9, 13 and 17; only Week 5 data presented. | From enrollment to week 5 of dosing |
| Phoenix |
| Arizona |
| 85054 |
| United States |
| Arizona Oncology Associates - USOR | Tucson | Arizona | 85704 | United States |
| University of Southern California | Beverly Hills | California | 90210 | United States |
| Alliance Research Centers | Laguna Hills | California | 92653 | United States |
| VA Greater Los Angeles Healthcare System | Los Angeles | California | 90073 | United States |
| San Bernardino Urological Associates | San Bernardino | California | 92404 | United States |
| Sharp Memorial Hospital | San Diego | California | 92123 | United States |
| Pacific Hematology Oncology Associates | San Francisco | California | 94115 | United States |
| San Francisco VA Health Care System | San Francisco | California | 94121 | United States |
| UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California | 94158 | United States |
| St. Joseph Heritage Healthcare | Santa Rosa | California | 95403 | United States |
| Kaiser Permanente, Northern CA | Vallejo | California | 94589 | United States |
| Rocky Mountain Cancer Centers | Aurora | Colorado | 80012 | United States |
| Yale University School of Medicine | New Haven | Connecticut | 06510 | United States |
| Medical Oncology Hematology Consultants - USOR | Newark | Delaware | 19713 | United States |
| Boca Raton Community Hospital, Inc. | Boca Raton | Florida | 33486 | United States |
| University of Florida Health Cancer Center | Orlando | Florida | 32806 | United States |
| Atlanta Urological Group | Atlanta | Georgia | 30312 | United States |
| Kaiser Permanente Medical Group | Honolulu | Hawaii | 96819 | United States |
| Ochsner Medical Center | New Orleans | Louisiana | 70121 | United States |
| University of Maryland Greenebaum Cancer Center | Baltimore | Maryland | 21201 | United States |
| Walter Reed National Military Medical Center | Bethesda | Maryland | 20889 | United States |
| Maryland Oncology Hematology P.A. | Columbia | Maryland | 21044 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| VA Ann Arbor Healthcare System | Ann Arbor | Michigan | 48105 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Minnesota Oncology Hematology, P.A. | Minneapolis | Minnesota | 55404 | United States |
| Minnesota Veterans Research Institute | Minneapolis | Minnesota | 55417 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Mayo Clinic - Rochester, MN | Rochester | Minnesota | 55902 | United States |
| Alegent Health Bergan Mercy Hospital , GU Research Network | Omaha | Nebraska | 68130 | United States |
| Nebraska Cancer Specialists | Omaha | Nebraska | 68130 | United States |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89169 | United States |
| Premier Urology Associates | Lawrenceville | New Jersey | 08648 | United States |
| Roswell Park | Buffalo | New York | 14263 | United States |
| NYU Perlmutter Cancer Center | New York | New York | 10016 | United States |
| Memorial Sloan Kettering CC | New York | New York | 10065 | United States |
| Weill Cornell Medical College | New York | New York | 10065 | United States |
| Premier Medical Group of the Hudson Valley PC | Poughkeepsie | New York | 12601 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | United States |
| University of North Carolina Lineberger Cancer Center | Chapel Hill | North Carolina | 27599 | United States |
| Carolina Urology Partners | Concord | North Carolina | 28025 | United States |
| Durham VA Medical Center | Durham | North Carolina | 27705 | United States |
| Oncology Hematology Care | Cincinnati | Ohio | 45211 | United States |
| The Urology Group | Cincinnati | Ohio | 45212 | United States |
| Kettering Medical Center | Kettering | Ohio | 45429 | United States |
| Clinical Research Solutions | Middleburg Heights | Ohio | 44130 | United States |
| VA Portland Health Care System | Portland | Oregon | 97219 | United States |
| Northwest Cancer Specialist DBA Compass Oncology | Portland | Oregon | 97227 | United States |
| Knight Cancer Institute | Portland | Oregon | 97239 | United States |
| Urology Associates Clinical Research | Nashville | Tennessee | 37209 | United States |
| Urology Clinics of North Texas | Dallas | Texas | 75231 | United States |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| UT Health Science Center | Houston | Texas | 77030 | United States |
| Texas Oncology Cancer Center-Round Rock | Round Rock | Texas | 78681 | United States |
| Urology of Virginia | Virginia Beach | Virginia | 23462 | United States |
| MultiCare Regional Cancer Center - Gig Harbor | Gig Harbor | Washington | 98335 | United States |
| VA Puget Sound HCS | Seattle | Washington | 98108 | United States |
| University of Washington Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109 | United States |
| Southside Cancer Care Centre | Miranda | New South Wales | 2228 | Australia |
| Orange Health Service | Orange | New South Wales | 2800 | Australia |
| Northern Cancer Insitute, St. Leonards | Saint Leonards | New South Wales | 2065 | Australia |
| St John of God Hospital, Subiaco | Subiaco | Western Australia | 6008 | Australia |
| Peninsula & Southeast Oncology | Frankston | 3199 | Australia |
| Barwon Health, University Hospital Geelong | Geelong | 3220 | Australia |
| Royal Hobart Hospital | Hobart | 7000 | Australia |
| Riverina Cancer Care Centre | Wagga Wagga | 2650 | Australia |
| ZNA Middelheim | Antwerp | 2020 | Belgium |
| AZ Groeninge | Kortrijk | 8500 | Belgium |
| CHU Sart-Tilman | Liège | 4000 | Belgium |
| Clinique et Maternité Sainte-Elisabeth | Namur | 5000 | Belgium |
| Tom Baker Cancer Centre | Calgary | Alberta | T2N 4N2 | Canada |
| Cancer Care Manitoba | Winnipeg | Manitoba | R3E 0V9 | Canada |
| Centre Hospitalier Universitaire Dr-Georges-L.-Dumont | Moncton | New Brunswick | E1C 8X3 | Canada |
| London Health Sciences Centre | London | Ontario | N6A 4L6 | Canada |
| The Ottawa Hospital | Ottawa | Ontario | K1H8L6 | Canada |
| Princess Margaret Cancer Centre | Toronto | Ontario | M5G 2M9 | Canada |
| Lakeridge Health Medical Specialty Medical Oncology | Oshawa | L1G 2B9 | Canada |
| Sunnybrook Odette Cancer Centre | Toronto | M4N3M5 | Canada |
| Copenhagen University Hospital | Copenhagen | 2100 | Denmark |
| Herlev Hospital | Herlev | 2730 | Denmark |
| Vejle Sygehus | Vejle | 7100 | Denmark |
| Centre Georges François Leclerc | Dijon | 21079 | France |
| Clinique Victor Hugo Centre Jean Bernard | Le Mans | 72000 | France |
| Hôpital Privé La Louvière | Lille | 59000 | France |
| Centre Léon Bérard | Lyon | 69008 | France |
| Polyclinique de Gentilly (Centre D'Oncologie De Gentilly) | Nancy | 54000 | France |
| Institut Curie | Paris | 75248 | France |
| Centre Armoricain de Radiotherapie, Imagerie medicale et Oncologie, CARIO | Plérin | 22190 | France |
| CRLCC Eugene Marquis | Rennes | 35042 | France |
| Institut Gustave-Roussy | Villejuif | 94805 | France |
| Gemeinschaftspraxis für Hämatologie&Onkologie | Augsburg | 86150 | Germany |
| Charite - Universitaetsmedizin Berlin | Berlin | 12200 | Germany |
| Apotheke des Städtischen Klinikums Braunschweig | Braunschweig | 38102 | Germany |
| Universitätsklinikum Köln | Cologne | 50937 | Germany |
| University Hospital Carl Gustav Carus | Dresden | 01307 | Germany |
| Universitatsklinikum Dusseldorf | Düsseldorf | 40225 | Germany |
| Urologische Gemeinschaftspraxis | Emmendingen | 79312 | Germany |
| Universitaetsklinikum Hamburg-Eppendorf (UKE) | Hamburg | 20246 | Germany |
| Universitatsklinikum Jena | Jena | 07747 | Germany |
| Universitätsklinikum Schleswig-Holstein | Lübeck | 23538 | Germany |
| Medizinischen Fakultät Mannheim der Universität Heidelberg | Mannheim | 68167 | Germany |
| Studienpraxis Urologie | Nürtingen | 72622 | Germany |
| University of Tuebingen | Tübingen | 72076 | Germany |
| Die GesundheitsUnion (DGU) | Wuppertal | 42103 | Germany |
| Cork University Hospital | Cork | Ireland |
| Adelaide & Meath Hospital, Incorporating the National Children's Hospital | Dublin | Ireland |
| Mater Misericordiae University Hospital | Dublin | Ireland |
| Mater Private Hospital (MPH) | Dublin | Ireland |
| St James's Hospital | Dublin | Ireland |
| St. Vincent's University Hospital | Dublin | Ireland |
| Rambam Health Care Campus (RHCC), Rambam Medical Center | Haifa | 3109601 | Israel |
| Hadassah University Hospital | Jerusalem | 91120 | Israel |
| Meir Medical Center | Kfar Saba | 4428164 | Israel |
| Rabin Medical Center-Beilinson Campus | Petah Tikva | 4941492 | Israel |
| The Tel Aviv Sourasky Medical Center (Ichilov Hospital) | Tel Aviv | 6423 | Israel |
| Chaim Sheba Medical Center | Tel Litwinsky | 5262000 | Israel |
| Ospedale San Donato, Azienda USLSUDEST | Arezzo | 52100 | Italy |
| Ospedale Santa Maria delle Croci | Faenza | 48018 | Italy |
| Romagnolo per lo Studio e la Cura dei Tumori IRST-IRCCS - Oncologia medica | Meldola | 47014 | Italy |
| IEO Instituto Europeo di Oncologia | Milan | 20141 | Italy |
| University of Modena and Reggio Emilia | Modena | 41124 | Italy |
| Azienda Ospedaliera San Camillo-Forlanini | Roma | 00152 | Italy |
| Azienda Opsedaliera S. Maria di Terni | Terni | 05100 | Italy |
| Presidio Ospedaliero Santa Chiara di Trento | Trento | 38122 | Italy |
| Hospital Universitari Germans Trias i Pujol | Barcelona | 08916 | Spain |
| Hospital Universitario Reina Sofia | Córdoba | 14004 | Spain |
| Hospital General Universitario de Guadalajara | Guadalajara | 19002 | Spain |
| Hospital Universitario Lucus Augusti. | Lugo | 27004 | Spain |
| MD Anderson Cancer Center - Madrid | Madrid | 28033 | Spain |
| Hospital Universitario Ramón y Cajal | Madrid | 28034 | Spain |
| Hospital 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Hospital Clinico Universitario Virgen de la Victoria | Málaga | 29010 | Spain |
| Hospital Universitario Central de Asturias | Oviedo | 33011 | Spain |
| Corporacio Sanitaria Parc Tauli | Sabadell | 08208 | Spain |
| Marques de Valdecilla University Hospital (HUMV) | Santander | 39008 | Spain |
| Hospital Universitario Virgen del Rocío | Seville | 41013 | Spain |
| Instituto Valenciano de Oncología | Valencia | 46009 | Spain |
| Guy's and St Thomas' NHS Foundation Trust | London | England | SE1 9RT | United Kingdom |
| Royal Marsden Hospital | London | England | SM2 5PT | United Kingdom |
| Oxford Cancer Centre, Medical Oncology Unit | Oxford | England | OX3 7LE | United Kingdom |
| Royal Preston Hospital | Preston | England | PR2 9HT | United Kingdom |
| Wexham Park Hospital | Slough | England | SL2 4HL | United Kingdom |
| Velindre Hospital | Cardiff | CF14 2TL | United Kingdom |
| Royal Marsden Hospital | London | SM2 5PT | United Kingdom |
| The Clatterbridge Cancer Centre NHS Foundation Trust | Metropolitan Borough of Wirral | CH63 4JY | United Kingdom |
| Musgrove Park Hospital | Taunton | TA15DA | United Kingdom |
| Derived |
| Collins K, Cheng L. Reprint of: morphologic spectrum of treatment-related changes in prostate tissue and prostate cancer: an updated review. Hum Pathol. 2023 Mar;133:92-101. doi: 10.1016/j.humpath.2023.02.007. Epub 2023 Mar 8. |
| 32203306 | Derived | Maia MC, Salgia M, Pal SK. Harnessing cell-free DNA: plasma circulating tumour DNA for liquid biopsy in genitourinary cancers. Nat Rev Urol. 2020 May;17(5):271-291. doi: 10.1038/s41585-020-0297-9. Epub 2020 Mar 17. |
| FG002 | Rucaparib (Cross-Over Phase) | Oral rucaparib (monotherapy). Rucaparib: Rucaparib will be administered daily. Participants from the Abiraterone Acetate/Enzalutamide/Docetaxel arm who completed the Treatment Phase and radiographically progressed by independent radiology review (IRR) may receive rucaparib treatment during the Cross-Over Phase. After analysis of the primary endpoint, investigator-assessed radiographic disease progression will be used for cross-over eligibility evaluation. |
| Received at Least 1 Dose of Study Drug |
|
| Safety Population |
|
| COMPLETED | Treatment period completion was defined as discontinuation when criteria for treatment discontinuation were met. |
|
| NOT COMPLETED |
|
|
| Cross-Over Phase |
|
Intent-to-Treat (ITT) Population included all randomized participants (participants with breast cancer gene [BRCA] mutated metastatic castration-resistant prostate cancer [mCRPC] and participants with ataxia- telangiectasia mutated serine/threonine kinase [ATM] mutated mCRPC).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Rucaparib | Oral rucaparib (monotherapy). Rucaparib: Rucaparib will be administered daily. |
| BG001 | Abiraterone Acetate or Enzalutamide or Docetaxel | Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone). Abiraterone acetate or Enzalutamide or Docetaxel: Abiraterone acetate and enzalutamide will be administered daily. Docetaxel will be administered every 3 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| ECOG Performance Status (at stratification) | Measure Description: Eastern Cooperative Oncology Group (ECOG) Performance Status Scale. ECOG 0 = Fully active, able to carry on all pre-disease performance without restriction. ECOG 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (eg, light house work or office work) | Count of Participants | Participants |
| |||||||||||||||||
| Gene Alteration (at stratification) | Count of Participants | Participants |
| ||||||||||||||||||
| Baseline prostate specific antigen (PSA) | Median | Full Range | ng/ml |
| |||||||||||||||||
| Gleason score ≥8 at diagnosis | The scale for the Gleason score ranges from 2 to 10, with higher scores indicating a worse prognosis | Count of Participants | Participants |
| |||||||||||||||||
| Measurable Disease per Independent Radiological Review (IRR) | Count of Participants | Participants |
| ||||||||||||||||||
| Metastases site(s) by IRR | Participants may be counted in more than one category | Count of Participants | Participants |
| |||||||||||||||||
| Prior Therapies for CRPC | Count of Participants | Participants |
| ||||||||||||||||||
| Prior therapy (2nd generation androgen receptor pathway inhibitor (ARPI) or docetaxel only) | Participants may be counted in more than one category | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Radiographic Progression-free Survival (rPFS) by IRR in Participants With a BRCA Alteration | The primary efficacy endpoint for the study is rPFSirr, defined as the time from randomization to the first objective evidence of radiographic progression, or death due to any cause (whichever occurs first). Radiographic disease progression includes confirmed soft tissue disease progression and confirmed bone disease progression as per modified RECIST Version 1.1 (at least a 20% increase in the sum of the LD of target lesions or appearance of one or more new extra-skeletal lesions and/or unequivocal progression of existing nontarget lesions) or PCWG3 criteria Progression by bone is determined by PCWG3 criteria in which at least two new lesions appearing during the first 12-week flare window followed by 2 additional new lesions in the confirmatory scan appearing after the 12-week flare window, or after the 12-week flare window, at least 2 new lesions relative to the first post-treatment scan confirmed on a subsequent scan). | ITT Population with BRCA mutated mCRPC. | Posted | Median | 95% Confidence Interval | months | From enrollment to primary completion of study (Total follow-up was up to approximately 4 years) |
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| Primary | Radiographic Progression-free Survival (rPFS) by IRR in Participants With a BRCA or ATM Alteration Combined | The primary efficacy endpoint for the study is rPFSirr, defined as the time from randomization to the first objective evidence of radiographic progression, or death due to any cause (whichever occurs first). Radiographic disease progression includes confirmed soft tissue disease progression and confirmed bone disease progression as per modified RECIST Version 1.1 (at least a 20% increase in the sum of the LD of target lesions or appearance of one or more new extra-skeletal lesions and/or unequivocal progression of existing nontarget lesions) or PCWG3 criteria (Progression by bone is determined by PCWG3 criteria in which at least two new lesions appearing during the first 12-week flare window followed by 2 additional new lesions in the confirmatory scan appearing after the 12-week flare window, or after the 12-week flare window, at least 2 new lesions relative to the first post-treatment scan confirmed on a subsequent scan). | ITT Population included all randomized participants (participants with BRCA mutated mCRPC and participants with ATM mutated mCRPC). | Posted | Median | 95% Confidence Interval | months | From enrollment to primary completion of study (Total follow-up was up to approximately 4 years) |
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| Secondary | Overall Survival in Participants With a BRCA Alteration | Overall survival time is calculated as the time from randomization to death (by any cause) +1 day. Participants who have not died will be censored on the date the participant was last known to be alive. | ITT Population with BRCA mutated mCRPC. | Posted | Median | 95% Confidence Interval | months | From enrollment to completion of study (up to approximately 7 years) |
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| Secondary | Overall Survival in Participants With a BRCA or ATM Alteration Combined | Overall survival time is calculated as the time from randomization to death (by any cause) +1 day. Participants who have not died will be censored on the date the participants was last known to be alive. | ITT Population included all randomized participants (participants with BRCA mutated mCRPC and participants with ATM mutated mCRPC). | Posted | Median | 95% Confidence Interval | months | From enrollment to completion of study (up to approximately 7 years) |
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| Secondary | Objective Response Rate (ORR) by IRR in Participants With a BRCA Alteration | ORR is defined as the percentage of participants with a confirmed best response of Complete response (CR) or Partial Response (PR) in participants with measurable disease at study entry. Modified RECIST Version 1.1 criteria is used to determine ORR (ie, CR or PR by IRR assessment and no progression in bone per PCWG3 by IRR assessment). CR is disappearance of all target and non-target lesions; any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. | ITT Population with BRCA mutated mCRPC and measurable disease at baseline. | Posted | Count of Participants | Participants | From enrollment to primary completion of study (Total follow-up was up to approximately 4 years) |
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| Secondary | Objective Response Rate (ORR) by IRR in Participants With a BRCA or ATM Alteration Combined | ORR is defined as the percentage of participants with a confirmed best response of Complete response (CR) or Partial Response (PR) in participants with measurable disease at study entry. Modified RECIST Version 1.1 criteria is used to determine ORR (ie, CR or PR by IRR assessment and no progression in bone per PCWG3 by IRR assessment). CR is disappearance of all target and non-target lesions; any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. | ITT Population included all randomized participants (participants with BRCA mutated mCRPC and participants with ATM mutated mCRPC) with measurable disease at baseline. | Posted | Count of Participants | Participants | From enrollment to primary completion of study (Total follow-up was up to approximately 4 years) |
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| Secondary | Duration of Response (DOR) by IRR in Participants With a BRCA Alteration | DOR is defined as the time from the first confirmed response (CR or PR by modified RECIST Version 1.1 in participants with nodal or visceral ± nodal disease) until the first date that Progressive Disease (PD) (using the same criteria) is documented. | ITT Population with BRCA mutated mCRPC and measurable disease at baseline. 'Overall number of participants analyzed' = participants with objective response. | Posted | Median | 95% Confidence Interval | months | From enrollment to primary completion of study (Total follow-up was up to approximately 4 years) |
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| Secondary | Duration of Response (DOR) by IRR in Participants With a BRCA or ATM Alteration Combined | DOR is defined as the time from the first confirmed response (CR or PR by modified RECIST Version 1.1 in participants with nodal or visceral ± nodal disease) until the first date that Progressive Disease (PD) (using the same criteria) is documented. | ITT Population included all randomized participants (participants with BRCA mutated mCRPC and participants with ATM mutated mCRPC) with measurable disease at baseline. 'Overall number of participants analyzed' = participants with objective response. | Posted | Median | 95% Confidence Interval | months | From enrollment to primary completion of study (Total follow-up was up to approximately 4 years) |
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| Secondary | PSA Response in Participants With a BRCA Alteration | Confirmed PSA response is defined as ≥ 50% reduction in PSA from baseline on at least two assessments conducted at least 3 weeks apart. PSA response is calculated for all participants with PSA values at baseline and at least one post-baseline assessment. PSA is assessed by a local laboratory. | ITT Population with BRCA mutated mCRPC. | Posted | Number | percentage of participants | From enrollment to primary completion of study (up to approximately 5 years) |
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| Secondary | PSA Response in Participants With a BRCA or ATM Alteration Combined | Confirmed PSA response is defined as ≥ 50% reduction in PSA from baseline on at least two assessments conducted at least 3 weeks apart. PSA response is calculated for all participants with PSA values at baseline and at least one post-baseline assessment. PSA is assessed by a local laboratory. | ITT Population included all randomized participants (participants with BRCA mutated mCRPC and participants with ATM mutated mCRPC). | Posted | Number | percentage of participants | From enrollment to primary completion of study (up to approximately 5 years) |
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| Secondary | Clinical Benefit Rate (CBR) by IRR at 6 Months in Participants With a BRCA Alteration | Defined as the percentage of participants with a complete response (CR), partial response (PR), and stable disease (SD) according to modified RECIST Version 1.1 with no progression in bone per PCWG3 criteria. | The Safety Population included all participants with BRCA mutated mCRPC who received at least one dose of protocol-specified treatment and had 6 months of follow-up prior to the data cutoff. | Posted | Number | percentage of participants | From enrollment to 6 months |
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| Secondary | Clinical Benefit Rate (CBR) by IRR at 6 Months in Participants With a BRCA or ATM Alteration Combined | Defined as the percentage of participants with a Complete Response (CR), Partial Response (PR), and Stable Disease (SD), according to Modified RECIST Version 1.1 with no progression in bone per PCWG3 Criteria. | The Safety Population included all participants who received at least one dose of protocol-specified treatment and had 6 months of follow-up prior to the data cutoff. | Posted | Number | percentage of participants | From enrollment to 6 months |
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| Secondary | Time to Prostate Specific Antigen (PSA) Progression in Participants With a BRCA Alteration | Time to PSA progression is defined as the time from randomization to the date that a ≥ 25% increase and absolute increase of ≥ 2 ng/mL above the nadir (or baseline value for participants who did not have a decline in PSA) in PSA was measured. The increase must be confirmed by a second consecutive assessment conducted at least 3 weeks later. | ITT Population with BRCA mutated mCRPC. | Posted | Median | 95% Confidence Interval | months | From enrollment to primary completion of study (up to approximately 5 years) |
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| Secondary | Time to Prostate Specific Antigen (PSA) Progression in Participants With a BRCA or ATM Alteration Combined | Time to PSA progression is defined as the time from randomization to the date that a ≥ 25% increase and absolute increase of ≥ 2 ng/mL above the nadir (or baseline value for participants who did not have a decline in PSA) in PSA was measured. The increase must be confirmed by a second consecutive assessment conducted at least 3 weeks later. | ITT Population included all randomized participants (participants with BRCA mutated mCRPC and participants with ATM mutated mCRPC). | Posted | Median | 95% Confidence Interval | months | From enrollment to primary completion of study (up to approximately 5 years) |
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| Secondary | Change in Patient-reported Outcome (PRO) in Participants With a BRCA Alteration: FACT-P | Changes in health and pain status from baseline to week 25 using: Functional Assessment of Cancer Therapy-Prostate questionnaire (FACT-P total score, on a scale of 0 to 156 where a higher score is better quality of life). The greater the decrease in score (ie more negative) from baseline to week 25 the greater the decrease in health status. Assessments completed during screening, at study treatment visits (Day 1, Day 15, Day 29, Day 43, Day 57, and every 29 days thereafter) (during the Treatment Phase, the Treatment Discontinuation Visit, and during the Follow-up Phase. | ITT Population with BRCA mutated mCRPC. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | Least Squares Mean | Standard Error | units on a scale | From enrollment to up to approximately 25 weeks |
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| Secondary | Change in Patient-reported Outcome (PRO) in Participants With a BRCA Alteration: BPI-SF | Changes in health and pain status from baseline to week 25 using: Brief Pain Inventory-Short Form (BPI-SF) questionnaire (on a scale of 1 to 10, from mild to severe, for pain and pain-interference scores). A decrease indicates less severe pain/interference. Assessments completed during screening, at study treatment visits (Day 1, Day 15, Day 29, Day 43, Day 57, and every 29 days thereafter) (during the Treatment Phase, the Treatment Discontinuation Visit, and during the Follow-up Phase. | ITT Population with BRCA mutated mCRPC. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable for specified category. | Posted | Mean | Standard Error | units on a scale | From enrollment to up to approximately 25 weeks |
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| Secondary | Change in Patient-reported Outcome (PRO) in Participants With a BRCA Alteration: EQ-5D-5L | Changes in health and pain status from baseline to week 25 using: EuroQol-5D-5L Visual Analogue Scale (EQ-5D-5L VAS; on a scale from 100 to 0, from best to worst health status). The greater the increase in score (including more negative) from baseline to week 25 the greater the increase in health status. Assessments completed during screening, at study treatment visits (Day 1, Day 15, Day 29, Day 43, Day 57, and every 29 days thereafter) during the Treatment Phase, the Treatment Discontinuation Visit, and during the Follow-up Phase. | ITT Population with BRCA mutated mCRPC. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | Least Squares Mean | Standard Error | units on a scale | From enrollment to up to approximately 25 weeks |
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| Secondary | Trough Plasma PK (Cmin) of Rucaparib Based on Sparse Sampling | Mean trough PK plasma concentration over time in the safety population with at least one PK sample collected at timepoints week 5, 9, 13 and 17; only Week 5 data presented. | Safety Population with at least 1 PK sample collected. | Posted | Median | Full Range | ng/mL | From enrollment to week 5 of dosing |
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From first dose of study drug through 28 days after receiving the last dose of study drug (approximately 7 years).
All-Cause Mortality is reported for the ITT population. SAEs and AEs were assessed in the Safety Population. After 28 days following last dose of study drug, only SAEs assessed as potentially related to study drug are reported. Events of progression of the participant's underlying cancer, events clearly related to progression of the participant's cancer and progression of disease leading to death are not reported as an AE or SAE.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rucaparib (Treatment Phase) | Oral rucaparib (monotherapy). Rucaparib: Rucaparib will be administered daily. | 6 | 270 | 81 | 270 | 270 | 270 |
| EG001 | Abiraterone Acetate or Enzalutamide or Docetaxel (Treatment Phase) | Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone). Abiraterone acetate or Enzalutamide or Docetaxel: Abiraterone acetate and enzalutamide will be administered daily. Docetaxel will be administered every 3 weeks. | 3 | 135 | 36 | 130 | 127 | 130 |
| EG002 | Rucaparib (Cross-over Phase) | Oral rucaparib (monotherapy). Rucaparib: Rucaparib will be administered daily. Participants from the Abiraterone Acetate/Enzalutamide/Docetaxel arm who completed the Treatment Phase and radiographically progressed by independent radiology review (IRR) may receive rucaparib treatment during the Cross-Over Phase. After analysis of the primary endpoint, investigator-assessed radiographic disease progression will be used for cross-over eligibility evaluation. | 1 | 70 | 18 | 70 | 67 | 70 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v23.0 | Systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA v23.0 | Systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | MedDRA v23.0 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA v23.0 | Systematic Assessment |
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| Pancytopenia | Blood and lymphatic system disorders | MedDRA v23.0 | Systematic Assessment |
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| Splenic haematoma | Blood and lymphatic system disorders | MedDRA v23.0 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA v23.0 | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA v23.0 | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA v23.0 | Systematic Assessment |
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| Ischaemic cardiomyopathy | Cardiac disorders | MedDRA v23.0 | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA v23.0 | Systematic Assessment |
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| Myocardial ischaemia | Cardiac disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Ventricular fibrillation | Cardiac disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA v23.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Oesophageal fistula | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
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| Oesophageal perforation | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
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| Oesophagitis | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
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| Rectal haemorrhage | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
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| Small intestinal obstruction | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA v23.0 | Systematic Assessment |
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| Death | General disorders | MedDRA v23.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA v23.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA v23.0 | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA v23.0 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA v23.0 | Systematic Assessment |
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| Pain | General disorders | MedDRA v23.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA v23.0 | Systematic Assessment |
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| Systemic inflammatory response syndrome | General disorders | MedDRA v23.0 | Systematic Assessment |
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| Cholangitis | Hepatobiliary disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA v23.0 | Systematic Assessment |
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| Cholecystitis acute | Hepatobiliary disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA v23.0 | Systematic Assessment |
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| Hepatotoxicity | Hepatobiliary disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Blastocystis infection | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
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| Campylobacter infection | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
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| Clostridium difficile colitis | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Dermo-hypodermitis | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
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| Device related infection | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
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| Infection | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
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| Respiratory tract infection | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Salmonella bacteraemia | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
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| Staphylococcal bacteraemia | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
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| Urinary tract infection bacterial | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
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| Urosepsis | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v23.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA v23.0 | Systematic Assessment |
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| Hip fracture | Injury, poisoning and procedural complications | MedDRA v23.0 | Systematic Assessment |
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| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA v23.0 | Systematic Assessment |
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| Subdural haemorrhage | Injury, poisoning and procedural complications | MedDRA v23.0 | Systematic Assessment |
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| Blood bilirubin increased | Investigations | MedDRA v23.0 | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA v23.0 | Systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA v23.0 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA v23.0 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v23.0 | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v23.0 | Systematic Assessment |
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| Malnutrition | Metabolism and nutrition disorders | MedDRA v23.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
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| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
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| Compartment syndrome | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
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| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | Systematic Assessment |
| |
| Malignant neoplasm of eyelid | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | Systematic Assessment |
| |
| Metastatic malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | Systematic Assessment |
| |
| Oesophageal squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
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| Facial paralysis | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
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| Neuralgia | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
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| Sacral radiculopathy | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
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| Seizure | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
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| Spinal cord compression | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA v23.0 | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA v23.0 | Systematic Assessment |
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| Renal colic | Renal and urinary disorders | MedDRA v23.0 | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA v23.0 | Systematic Assessment |
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| Bronchopneumopathy | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
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| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA v23.0 | Systematic Assessment |
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| Orthostatic hypotension | Vascular disorders | MedDRA v23.0 | Systematic Assessment |
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| Thrombophlebitis superficial | Vascular disorders | MedDRA v23.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v23.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA v23.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v23.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Taste disorder | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v23.0 | Systematic Assessment |
|
Sponsor's agreements with investigators require proposed public disclosures of trial results to be submitted to Sponsor for review prior to publication. Sponsor may request deletion of confidential information or a delay in publication to address intellectual property concerns, but Sponsor may not suppress publication of the trial results indefinitely. Sponsor may request delay of a single-center publication until after the release of a multi-site publication or an agreed upon period of time.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Information Department | pharmaand GmbH | +43/1/3560006 | medinfo@pharmaand.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 1, 2022 | Jun 2, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| C531549 | rucaparib |
| D000069501 | Abiraterone Acetate |
| C540278 | enzalutamide |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Europe |
|
| Australia |
|
| Israel |
|
| 1 |
|
| BRCA2 |
|
| ATM |
|
| Nodal |
|
| Visceral |
|
| ≥1 |
|
| Apalutamide |
|
| Enzalutamide |
|
| Docetaxel for hormone-sensitive prostate cancer |
|
Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone).
Abiraterone acetate or Enzalutamide or Docetaxel: Abiraterone acetate and enzalutamide will be administered daily.
Docetaxel will be administered every 3 weeks.
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| Participants |
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| Participants |
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| Participants |
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| Participants |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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