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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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This randomized study is looking at the benefits of using docetaxel (chemotherapy) added to one of the standard treatments (radiation and hormones) for men with high-risk prostate cancer.
Radiation therapy plus six months of hormone therapy is one standard way of treating men with high-risk prostate cancer. In this study, we want to see whether or not adding the chemotherapy drug docetaxel (Taxotere)will make this treatment more effective. Docetaxel has shown a benefit in median survival when given to men who have become resistant to hormonal therapy and in men who have metastatic prostate cancer (spread to other areas of the body).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm1: Androgen Suppression Therapy + Radiation Therapy | Other | Androgen Suppression Therapy and Radiation therapy |
|
| Arm 2: Docetaxel + Androgen Suppression Therapy + Radiation Therapy | Experimental | Docetaxel plus androgen suppression therapy and radiation therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel | Drug | 60 mg/m² q 3 weeks for 3 cycle at the start of treatment followed by weekly Docetaxel at 20 mg/m² per week beginning at week one of radiation therapy and continuing for seven weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| 10-Year Restricted Mean Survival Time for Overall Survival | Overall survival (OS) was measured from the date of random assignment to death from any cause, censored at the date of last follow-up in surviving patients. The 10-Year Restricted Mean Survival Time was calculated as the area under the Kaplan Meier plot for OS, from randomization to 10-years follow-up | Following the end of RT patients were seen for follow up every 6 months for 5 years and annually thereafter, 10 years. |
| Measure | Description | Time Frame |
|---|---|---|
| 10-year Biochemical Recurrence (PSA Failure) | Time to biochemical recurrence was defined as the time from date of random assignment to the earliest of PSA failure or initiation of salvage therapy, or censored at the date of last disease assessment for those without PSA failure. PSA failure was defined according to the 2006 RTOG-ASTRO Phoenix definition (i.e., A PSA rise by 2 ng/mL or more above the nadir). 10-year biochemical recurrence rate was estimated from a competing risk model where non-prostate cancer death was counted as competing risk. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anthony V. D'Amico, MD, PhD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana-Farber Cancer Institute and (Sanofi-Aventis Consortium) | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38691823 | Derived | Sayan M, Chen MH, Loffredo M, McMahon E, Moningi S, Orio PF, Nguyen PL, D'Amico AV. Elective Pelvic Lymph Node Radiation Therapy and the Risk of Death in Patients With Unfavorable-Risk Prostate Cancer: A Postrandomization Analysis. J Clin Oncol. 2024 Jul 20;42(21):2558-2564. doi: 10.1200/JCO.23.02394. Epub 2024 May 1. | |
| 37801315 |
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9/21/2005 to 1/13/2015
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm1: Androgen Suppression Therapy + Radiation Therapy | Androgen Suppression Therapy + Radiation therapy Weeks 1-9: total androgen suppression Weeks 10-17: total androgen suppression and external beam radiation Weeks 18-26: total androgen suppression |
| FG001 | Arm2: Docetaxel + Androgen Suppression Therapy + Radiation Therapy |
| 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 2, 2005 |
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|
| Androgen Hormonal Suppression and Radiation | Drug | Total Androgen Ablation and external beam radiation therapy |
|
| Androgen Suppression Therapy and Radiation Therapy | Drug | Total Androgen Ablation and External Beam Radiation Therapy |
|
| PSA was measured following the end of RT, then every 6 months for 5 years and annually thereafter, 10 years |
| 10-year Prostate Cancer Mortality | Measured from the date of random assignment to date of death from prostate cancer, or censored at the date of last follow-up in surviving patients. Patients who died due to other reasons were counted as competing risk in a competing risk model. | Following the end of RT patients were seen for follow up every 6 months for 5 years and annually thereafter, 10 years. |
| Number of Participants With Acute Adverse Events | Adverse acute events were reported via the clinical database only for toxicities considered reportable via the SAE mechanism (those of grade 2 and grade 3 events that are unexpected and possibly, probably, or definitely related/associated with treatment; or all grade 4 and grade 5 events). Common Toxicity Criteria Volume 3.0 (CTCAE) is used for this study. | During study treatment or within 30 days of the last dose of study, up to 7.2 months from randomization |
| Number of Participants With Late Adverse Events, Any Grade and Attribution | Late adverse events will be focused on GU/GI including Urinary/Fecal Incontinence, Hematuria, Diarrhea, Rectal Bleeding and other. | Every 6 months post radiation therapy for 5 years (+/-90 days), then annually, up to 13.9 years from randomization |
| Sayan M, Huang J, Xie W, Chen MH, Loffredo M, McMahon E, Orio P, Nguyen P, D'Amico AV. Risk of Short-Term Prostate-Specific Antigen Recurrence and Failure in Patients With Prostate Cancer: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2023 Oct 2;6(10):e2336390. doi: 10.1001/jamanetworkopen.2023.36390. |
| 34197181 | Derived | D'Amico AV, Xie W, McMahon E, Loffredo M, Medeiros S, Joseph D, Denham J, Kumar P, Bubley G, Sullivan M, Hellwig R, Carlos Vera J, Freter R, Jeffrey Baker W, Wong JY, Renshaw AA, Kantoff PW. Radiation and Androgen Deprivation Therapy With or Without Docetaxel in the Management of Nonmetastatic Unfavorable-Risk Prostate Cancer: A Prospective Randomized Trial. J Clin Oncol. 2021 Sep 10;39(26):2938-2947. doi: 10.1200/JCO.21.00596. Epub 2021 Jul 1. |
| 24423462 | Derived | Guttilla A, Bortolus R, Giannarini G, Ghadjar P, Zattoni F, Gnech M, Palumbo V, Valent F, Garbeglio A, Zattoni F. Multimodal treatment for high-risk prostate cancer with high-dose intensity-modulated radiation therapy preceded or not by radical prostatectomy, concurrent intensified-dose docetaxel and long-term androgen deprivation therapy: results of a prospective phase II trial. Radiat Oncol. 2014 Jan 14;9:24. doi: 10.1186/1748-717X-9-24. |
Docetaxel + Androgen Suppression Therapy + Radiation Therapy Weeks 1-9: total androgen suppression and docetaxel 60 mg/m2/q3 weeks x 3 cycles Weeks 10-17: total androgen suppression + external beam radiation therapy + docetaxel 20 mg/m2/week beginning at week 10 x 7 cycles Weeks 18-26: total androgen suppression |
| Treated |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm1: Androgen Suppression Therapy + Radiation Therapy | Androgen Suppression Therapy + Radiation therapy Weeks 1-9: total androgen suppression Weeks 10-17: total androgen suppression and external beam radiation Weeks 18-26: total androgen suppression |
| BG001 | Arm2: Docetaxel + Androgen Suppression Therapy + Radiation Therapy | Docetaxel + Androgen Suppression Therapy + Radiation Therapy Weeks 1-9: total androgen suppression and docetaxel 60 mg/m2/q3 weeks x 3 cycles Weeks 10-17: total androgen suppression + external beam radiation therapy + docetaxel 20 mg/m2/week beginning at week 10 x 7 cycles Weeks 18-26: total androgen suppression |
| 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 | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | 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 | 10-Year Restricted Mean Survival Time for Overall Survival | Overall survival (OS) was measured from the date of random assignment to death from any cause, censored at the date of last follow-up in surviving patients. The 10-Year Restricted Mean Survival Time was calculated as the area under the Kaplan Meier plot for OS, from randomization to 10-years follow-up | Posted | Mean | Standard Error | years | Following the end of RT patients were seen for follow up every 6 months for 5 years and annually thereafter, 10 years. |
|
|
| |||||||||||||||||||||||||||||
| Secondary | 10-year Biochemical Recurrence (PSA Failure) | Time to biochemical recurrence was defined as the time from date of random assignment to the earliest of PSA failure or initiation of salvage therapy, or censored at the date of last disease assessment for those without PSA failure. PSA failure was defined according to the 2006 RTOG-ASTRO Phoenix definition (i.e., A PSA rise by 2 ng/mL or more above the nadir). 10-year biochemical recurrence rate was estimated from a competing risk model where non-prostate cancer death was counted as competing risk. | Posted | Number | 95% Confidence Interval | percentage of subjects | PSA was measured following the end of RT, then every 6 months for 5 years and annually thereafter, 10 years |
| |||||||||||||||||||||||||||||||
| Secondary | 10-year Prostate Cancer Mortality | Measured from the date of random assignment to date of death from prostate cancer, or censored at the date of last follow-up in surviving patients. Patients who died due to other reasons were counted as competing risk in a competing risk model. | Posted | Number | 95% Confidence Interval | percentage of subjects | Following the end of RT patients were seen for follow up every 6 months for 5 years and annually thereafter, 10 years. |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Acute Adverse Events | Adverse acute events were reported via the clinical database only for toxicities considered reportable via the SAE mechanism (those of grade 2 and grade 3 events that are unexpected and possibly, probably, or definitely related/associated with treatment; or all grade 4 and grade 5 events). Common Toxicity Criteria Volume 3.0 (CTCAE) is used for this study. | Adverse acute events were evaluated in patients who received at least one dose of protocol treatment (174 out of 175 subjects in Arm1, 171 out of 175 subjects in Arm2). | Posted | Count of Participants | Participants | During study treatment or within 30 days of the last dose of study, up to 7.2 months from randomization |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Late Adverse Events, Any Grade and Attribution | Late adverse events will be focused on GU/GI including Urinary/Fecal Incontinence, Hematuria, Diarrhea, Rectal Bleeding and other. | Adverse late event was evaluated in patients who received at least one dose of protocol treatment (174 out of 175 subjects in Arm1, 171 out of 175 subjects in Arm2). | Posted | Count of Participants | Participants | Every 6 months post radiation therapy for 5 years (+/-90 days), then annually, up to 13.9 years from randomization |
|
Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
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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 | Arm1: Androgen Suppression Therapy + Radiation Therapy | Androgen Suppression Therapy and Radiation therapy Androgen Hormonal Suppression and Radiation: Total Androgen Ablation and external beam radiation therapy Androgen Suppression Therapy and Radiation Therapy: Total Androgen Ablation and External Beam Radiation Therapy | 45 | 175 | 63 | 174 | 128 | 174 |
| EG001 | Arm 2: Docetaxel + Androgen Suppression Therapy + Radiation Therapy | Docetaxel plus androgen suppression therapy and radiation therapy Docetaxel: 60 mg/m² q 3 weeks for 3 cycle at the start of treatment followed by weekly Docetaxel at 20 mg/m² per week beginning at week one of radiation therapy and continuing for seven weeks. Androgen Hormonal Suppression and Radiation: Total Androgen Ablation and external beam radiation therapy Androgen Suppression Therapy and Radiation Therapy: Total Androgen Ablation and External Beam Radiation Therapy | 44 | 175 | 87 | 171 | 142 | 171 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Weight loss | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Perforation, colon | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pulmonary/Upper Respiratory-other | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Skin-other | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Thrombosis/thrombus/embolism | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Ulcer, duodenum | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cardiac-ischemia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cystitis | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hot flashes | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bladder anastomotic leak | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| (ARDS) | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bronchospasm, wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| C5 tetraplegia | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| CNS cerebrovascular ischemia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fever w/o neutropenia | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Gynecomastia | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Infection Gr0-2 neut, urinary tract | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Infection w/ gr 3-4 neut, blood | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Infection w/ unk ANC lung | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Leukocytes | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Liver dysfunction/failure | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Musculoskeletal/soft tissue-other | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Allergic reaction | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Infection-other | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cardiac-other | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Erectile impotence | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Incontinence, anal | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rectum, hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Incontinence urinary | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Neutrophils | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| GI-other | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bladder, hemorrhage | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Diarrhea w/o prior colostomy | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Urinary frequency/urgency | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Renal/GU-other | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bladder spasms | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Constitutional, other | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Death - sudden death | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Distention/bloating, abdominal | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Endocrine-other | Endocrine disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Infection Gr0-2 neut, lung | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bladder, hemorrhage | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ALT, SGPT | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bladder spasms | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bladder, hemorrhage | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cardiac-other | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Chest/thoracic pain NOS | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Constitutional, other | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cystitis | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Diarrhea w/o prior colostomy | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Erectile impotence | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| GI-other | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Incontinence urinary | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Incontinence, anal | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Infection Gr0-2 neut, urinary tract | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Infection w/ unk ANC wound | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Infection-other | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Bladder anastomotic leak | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pleural effusion (non-malignant) | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pulmonary/Upper Respiratory-other | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rectum, hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Renal/GU-other | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rigors/chills | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Stenosis (incl anastomotic) small bowel | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Testicle, pain | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Thrombosis/thrombus/embolism | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Upper GI, hemorrhage NOS | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Urinary frequency/urgency | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Vasovagal episode | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anthony D'Amico | Dana Farber Cancer Institute | 617.732.6310 | ADAMICO@LROC.HARVARD.EDU |
| Jul 7, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D009362 | Neoplasm Metastasis |
| 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 |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D011827 | Radiation |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D055585 | Physical Phenomena |
| D013812 | Therapeutics |
Not provided
Not provided
| Male |
|
| Black or African American |
|
| Asian |
|
| Other |
|
| Australia |
|
| New Zealand |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|