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| ID | Type | Description | Link |
|---|---|---|---|
| 56021927PCR2041 | Other Identifier | Janssen Research & Development, LLC |
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Main Study: The purpose of main study is to assess if the combination of apalutamide and androgen deprivation therapy (ADT) in participants with high-risk localized prostate cancer improves the biochemical recurrence (BCR) free rate.
Sub-study: The purpose of the sub-study is to assess if the co administration of apalutamide and relugolix is able to maintain castrate levels of testosterone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apalutamide + Androgen Deprivation Therapy (ADT) | Experimental | In the main study, participants will receive apalutamide 240 milligram (mg) once daily orally along with ADT for 12 cycles (Each cycle is of 28 days). Participants who enrolled in the sub-study will receive apalutamide 240 mg once daily along with relugolix (a type of ADT) 120 mg once daily following a loading dose of 360 mg relugolix orally. Sub-study participants will be receiving relugolix up to Day 28 after which they will be transitioned into the main study from Cycle 2 Day 1 and will continue to receive conventional or oral ADT. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apalutamide | Drug | Participants will receive apalutamide 240 mg (4 tablets of 60 mg each) oral tablets during the main study and sub-study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Confirmed Biochemical Recurrence (BCR)-Free Rate at Month 24 | Confirmed BCR-free rate was estimated from primary efficacy variable, time to confirmed BCR. This was measured as the interval between the date of the first dose of study drug and the date of the first occurrence of confirmed prostate specific antigen (PSA) greater than (>) 0.2 nanogram per milliliter (ng/mL). Confirmation of the PSA value was conducted within 3 to 4 weeks, regardless of study visit and timing. Participants without confirmed PSA > 0.2 ng/mL (including those who were lost to follow-up) were censored on their last PSA measurement date during the treatment phase of the study. | At Month 24 |
| Sub-study: Percentage of Participants Who Maintained Testosterone Level Less Than (<) 50 Nanograms Per Deciliter (ng/dL) Through Day 28 | Percentage of participants maintaining testosterone level <50 ng/dL through Day 28 were reported. | From Day -14 through Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Confirmed Biochemical Recurrence (BCR)-Free Rate at Month 12 | Confirmed BCR-free rate was estimated from primary efficacy variable, time to confirmed BCR. This was measured as the interval between the date of the first dose of study drug and the date of the first occurrence of confirmed PSA >0.2 ng/mL. Confirmation of the PSA value was conducted within 3 to 4 weeks, regardless of study visit and timing. Participants without confirmed PSA > 0.2 ng/mL (including those who were lost to follow-up) were censored on their last PSA measurement date during the treatment phase of the study. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Urology Specialists 1 | Tucson | Arizona | 85704 | United States | ||
| Arizona Urology Specialists |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39088398 | Derived | Shore N, Hafron J, Saltzstein D, Brown G, Belkoff L, Aggarwal P, Phillips J, Bhaumik A, McGowan T. Apalutamide for High-Risk Localized Prostate Cancer Following Radical Prostatectomy (Apa-RP). J Urol. 2024 Nov;212(5):682-691. doi: 10.1097/JU.0000000000004163. Epub 2024 Aug 1. | |
| 36472728 | Derived | Brown G, Belkoff L, Hafron JM, Saltzstein DR, Potdar R, Bhaumik A, Phillips J, McGowan T, Shore ND. Coadministration of Apalutamide and Relugolix in Patients with Localized Prostate Cancer at High Risk for Metastases. Target Oncol. 2023 Jan;18(1):95-103. doi: 10.1007/s11523-022-00932-8. Epub 2022 Dec 6. |
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The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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Study consisted of main study (12 treatment cycles) and sub study (single treatment cycle). Each cycle was of 28 days. Unique participants were enrolled either into main or sub-study. Study treatment was initiated between Day 29 and 90 post radical prostatectomy. After sub-study completion and serum testosterone assessment (primary analysis) and safety (secondary analysis), participants were transitioned into main study from Cycle 2 Day 1 and continued treatment through Cycle 12 in main study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Main Study: Apalutamide Plus Androgen Deprivation Therapy (ADT) | In main study, participants received apalutamide 240 milligrams (mg; 4 tablets of 60 mg) orally once daily (QD) along with ADT intramuscular or subcutaneous injection from Cycle 1 Day 1 up to Cycle 12. Each cycle was of 28 days. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 20, 2021 | Oct 25, 2024 |
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|
| ADT | Drug | Participants will receive ADT intramuscular or subcutaneously during the main study. |
|
| Relugolix | Drug | Participants will receive 120 mg of relugolix following a loading dose of 360 mg of (3 tablets of 120 mg each) relugolix during the sub-study. |
|
| At Month 12 |
| Serum Testosterone Recovery (>=150 ng/dL) at Months 18 and 24 | Percentage of participants with serum testosterone recovery (>=150 ng/dL) at Months 18 and 24 were reported. Testosterone recovery was defined as a serum testosterone level greater than or equal to (>=)150 nanograms per deciliter (ng/dL). | At Months 18 and 24 |
| Sub-study: Number of Participants With Treatment-emergent Adverse Events | An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product and it does not necessarily have a causal relationship with the intervention. TEAEs were defined as any AEs with onset or worsening on or after date of first dose of study intervention through the day of last dose in sub-study. | From 1st dose of study intervention (relugolix on Day -14) up to end of sub-study (Day 28) |
| Tucson |
| Arizona |
| 85741 |
| United States |
| Arkansas Urology | Little Rock | Arkansas | 72211 | United States |
| Skyline Urology | Sherman Oaks | California | 91411 | United States |
| Genesis Research | Torrance | California | 90505 | United States |
| The Urology Center of Colorado | Denver | Colorado | 80211 | United States |
| Foothills Urology - Golden Off | Lakewood | Colorado | 80228 | United States |
| Urological Research Network | Hialeah | Florida | 33016 | United States |
| Idaho Urologic Institute | Meridian | Idaho | 83642 | United States |
| First Urology, PSC | Jeffersonville | Indiana | 47130 | United States |
| The Iowa Clinic | West Des Moines | Iowa | 50266 | United States |
| Wichita Urology Group | Wichita | Kansas | 67226 | United States |
| Ochsner LSU Health Shreveport - Regional Urology | Shreveport | Louisiana | 71106 | United States |
| Michigan Institute of Urology, PC | Troy | Michigan | 48084 | United States |
| Adult Pediatric Urology & Urogynecology, P.C | Omaha | Nebraska | 68114 | United States |
| New Jersey Urology LLC | Voorhees Township | New Jersey | 08043 | United States |
| Great Lakes Physician PC d/b/a Western New York Urology Associates | Cheektowaga | New York | 14225 | United States |
| Associated Medical Professionals | Syracuse | New York | 13210 | United States |
| Associated Urologists of North Carolina | Raleigh | North Carolina | 27612 | United States |
| The Urology Group | Cincinnati | Ohio | 45212 | United States |
| Oregon Urology Institute | Springfield | Oregon | 97477 | United States |
| MidLantic Urology | Bala-Cynwyd | Pennsylvania | 19004 | United States |
| Lancaster Urology | Lancaster | Pennsylvania | 17604 | United States |
| Carolina Urologic Research Center | Myrtle Beach | South Carolina | 29572 | United States |
| Lexington Urology | West Columbia | South Carolina | 20169 | United States |
| Urology Associates | Nashville | Tennessee | 37209 | United States |
| Urology Austin | Austin | Texas | 78745 | United States |
| Houston Metro Urology | Houston | Texas | 77027 | United States |
| Urology San Antonio Research | San Antonio | Texas | 78229 | United States |
| Virginia Urology | Richmond | Virginia | 23235 | United States |
| Urology Of Virginia, Pllc | Virginia Beach | Virginia | 23462 | United States |
| Spokane Urology | Spokane | Washington | 99202 | United States |
| Sub Study: Relugolix Followed by Apalutamide Plus Relugolix |
In sub-study, participants received a loading dose of relugolix 360 mg (3 tablets of 120 mg) on Day -14 and then relugolix 120 mg orally QD up to Day 28 and accompanied by apalutamide 240 mg (4 tablets of 60 mg tablets) orally QD from Day 1 up to Day 28. Upon completion of 28-day sub-study, participants were transitioned into the main study from Cycle 2 Day 1 and continued to receive apalutamide with ADT (oral relugolix) through Cycle 12. Each cycle was of 28 days. |
| Sub-study Participants Who Completed and Transitioned to Main Study |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Main Study: Apalutamide Plus Androgen Deprivation Therapy (ADT) | In main study, participants received apalutamide 240 milligrams (mg; 4 tablets of 60 mg) orally once daily (QD) along with ADT intramuscular or subcutaneous injection from Cycle 1 Day 1 up to Cycle 12. Each cycle was of 28 days. |
| BG001 | Sub Study: Relugolix Followed by Apalutamide Plus Relugolix | In sub-study, participants received a loading dose of relugolix 360 mg (3 tablets of 120 mg) on Day -14 and then relugolix 120 mg orally QD up to Day 28 and accompanied by apalutamide 240 mg (4 tablets of 60 mg tablets) orally QD from Day 1 up to Day 28. Upon completion of 28-day sub-study, participants were transitioned into the main study from Cycle 2 Day 1 and continued to receive apalutamide with ADT (oral relugolix) through Cycle 12. Each cycle was of 28 days. |
| 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, Continuous | Mean | Standard Deviation | 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 | 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 | Confirmed Biochemical Recurrence (BCR)-Free Rate at Month 24 | Confirmed BCR-free rate was estimated from primary efficacy variable, time to confirmed BCR. This was measured as the interval between the date of the first dose of study drug and the date of the first occurrence of confirmed prostate specific antigen (PSA) greater than (>) 0.2 nanogram per milliliter (ng/mL). Confirmation of the PSA value was conducted within 3 to 4 weeks, regardless of study visit and timing. Participants without confirmed PSA > 0.2 ng/mL (including those who were lost to follow-up) were censored on their last PSA measurement date during the treatment phase of the study. | Modified intent-to-treat (MITT) analysis set included all participants who were enrolled in the study, received at least 1 dose of apalutamide, and had a baseline prostate-specific antigen (PSA) and at least 1 post-treatment PSA assessment. Data for this outcome measures was planned to be collected and analyzed for combined population of main study and sub-study (after the participants transitioned into main study). | Posted | Number | 90% Confidence Interval | Percentage of participants | At Month 24 |
|
|
| |||||||||||||||||||||||||
| Primary | Sub-study: Percentage of Participants Who Maintained Testosterone Level Less Than (<) 50 Nanograms Per Deciliter (ng/dL) Through Day 28 | Percentage of participants maintaining testosterone level <50 ng/dL through Day 28 were reported. | MITT analysis set included all participants were enrolled in the study, received at least 1 dose of apalutamide, and had a baseline PSA and at least 1 post-treatment PSA assessment. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for main study. | Posted | Number | Percentage of participants | From Day -14 through Day 28 |
|
| |||||||||||||||||||||||||||
| Secondary | Confirmed Biochemical Recurrence (BCR)-Free Rate at Month 12 | Confirmed BCR-free rate was estimated from primary efficacy variable, time to confirmed BCR. This was measured as the interval between the date of the first dose of study drug and the date of the first occurrence of confirmed PSA >0.2 ng/mL. Confirmation of the PSA value was conducted within 3 to 4 weeks, regardless of study visit and timing. Participants without confirmed PSA > 0.2 ng/mL (including those who were lost to follow-up) were censored on their last PSA measurement date during the treatment phase of the study. | MITT analysis set included all participants were enrolled in the study, received at least 1 dose of apalutamide, and had a baseline PSA and at least 1 post-treatment PSA assessment. Data for this outcome measures was planned to be collected and analyzed for combined population of main study and sub-study (after the participants transitioned into main study). | Posted | Number | 90% Confidence Interval | Percentage of participants | At Month 12 |
| |||||||||||||||||||||||||||
| Secondary | Serum Testosterone Recovery (>=150 ng/dL) at Months 18 and 24 | Percentage of participants with serum testosterone recovery (>=150 ng/dL) at Months 18 and 24 were reported. Testosterone recovery was defined as a serum testosterone level greater than or equal to (>=)150 nanograms per deciliter (ng/dL). | MITT analysis set included all participants were enrolled in the study, received at least 1 dose of apalutamide, and had a baseline PSA and at least 1 post-treatment PSA assessment. Data for this outcome measures was planned to be collected and analyzed for combined population of main study and sub-study (after the participants transitioned into main study). | Posted | Number | 95% Confidence Interval | Percentage of participants | At Months 18 and 24 |
| |||||||||||||||||||||||||||
| Secondary | Sub-study: Number of Participants With Treatment-emergent Adverse Events | An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product and it does not necessarily have a causal relationship with the intervention. TEAEs were defined as any AEs with onset or worsening on or after date of first dose of study intervention through the day of last dose in sub-study. | Safety analysis set included all participants who received at least 1 dose of apalutamide. Data for this outcome measure was not planned to be collected and analyzed for main study. | Posted | Count of Participants | Participants | From 1st dose of study intervention (relugolix on Day -14) up to end of sub-study (Day 28) |
|
|
Main study and sub-study combined: From first dose of study drug (Cycle 1 Day 1 for main study and Cycle 2 Day 1 for sub-study [post transition into main study]) up to end of study (Month 36); sub-study alone: From Day -14 up to end of sub-study treatment (Day 28)
Safety analysis set included all participants who received at least 1 dose of apalutamide. Adverse events data were planned to be collected and analyzed for unique sub-study participants alone and for combined population (along with main study after sub-study participants transitioned into main study).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Main Study Plus Sub-study (Post Transition) | In main study, participants received apalutamide 240 milligrams (mg; 4 tablets of 60 mg) orally once daily (QD) along with ADT intramuscular or subcutaneous injection from Cycle 1 Day 1 up to Cycle 12. Each cycle was of 28 days. Sub-study participants upon completion of 28-day sub-study treatment were transitioned into the main study from Cycle 2 Day 1 and continued to receive apalutamide with ADT (oral relugolix) and were included in the main study analysis. | 0 | 108 | 16 | 108 | 107 | 108 |
| EG001 | Sub Study Alone (Before Transition) | In sub-study, participants received a loading dose of relugolix 360 mg (3 tablets of 120 mg) on Day -14 and then relugolix 120 mg orally QD up to Day 28 and accompanied by apalutamide 240 mg (4 tablets of 60 mg tablets) orally QD from Day 1 up to Day 28. Upon completion of 28-day sub-study, participants were transitioned into the main study from Cycle 2 Day 1. | 0 | 12 | 0 | 12 | 8 | 12 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Abdominal Incarcerated Hernia | Gastrointestinal disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Cholecystitis Acute | Hepatobiliary disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Post Procedural Haemorrhage | Injury, poisoning and procedural complications | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Colon Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Squamous Cell Carcinoma of the Tongue | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Transient Ischaemic Attack | Nervous system disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Bladder Neck Obstruction | Renal and urinary disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Stevens-Johnson Syndrome | Skin and subcutaneous tissue disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Hypertensive Crisis | Vascular disorders | MedDRA Version 26.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Hot Flush | Vascular disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Restless legs syndrome | Nervous system disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Taste disorder | Nervous system disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Increased appetite | Metabolism and nutrition disorders | MedDRA Version 26.0 | Non-systematic Assessment |
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If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application..
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Group Medical Director Oncology | Janssen Research & Development, LLC | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 14, 2023 | Oct 25, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C572045 | apalutamide |
| C561634 | relugolix |
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| 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 |
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
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|
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