Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| SWOG-9346 | |||
| CAN-NCIC-PR8 | |||
| CALGB-9594 | |||
| ECOG-S9346 | |||
| EORTC-30985 | |||
| CAN-NCIC-JPR8 | |||
| INT-0162 |
Not provided
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| NCIC Clinical Trials Group | NETWORK |
| Cancer and Leukemia Group B | NETWORK |
| Eastern Cooperative Oncology Group |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
RATIONALE: Testosterone can stimulate the growth of prostate cancer cells. Hormone therapy may be effective treatment for prostate cancer. It is not yet known which regimen of hormone therapy is most effective for stage IV prostate cancer.
PURPOSE: This randomized phase III trial is studying two different regimens of hormone therapy and comparing how well they work in treating men with stage IV prostate cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to SWOG performance status (0-1 vs 2), severity of disease (minimal vs extensive), and prior hormonal therapy (neoadjuvant hormonal therapy vs finasteride vs neither).
Induction therapy: Patients receive combined androgen-deprivation (CAD) therapy comprising goserelin subcutaneously once a month and oral bicalutamide once daily for 8 courses (7 months).
Consolidation therapy: Patients are randomized to 1 of 2 consolidation regimens.
Quality of life is assessed before induction therapy, at 3 months (before consolidation therapy), and then at 9 and 15 months.
Patients are followed every 6-12 months for at least 10 years.
PROJECTED ACCRUAL: Approximately 1,500 patients will be accrued for this study.
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Consolidation arm I | Active Comparator | Patients continue CAD therapy comprising goserelin subcutaneously once a month and oral bicalutamide once daily. Treatment continues in the absence of disease progression. |
|
| Consolidation arm II | Experimental | Patients undergo observation in the absence of rising prostate-specific antigen (PSA) or clinical symptoms of progressive disease. Patients with rising PSA or progressive disease begin CAD therapy as in consolidation arm I. Patients whose PSA normalizes after 8 courses return to observation. Patients whose PSA does not normalize after 8 courses continue CAD therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bicalutamide | Drug | Given orally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Non-inferiority test to determine if intermittent combined androgen deprivation (CAD) overall survival is not substantially worse than continuous CAD overall survival. Specifically, the trial is designed for a one-sided test of the hypothesis that the hazard ratio of intermittent CAD to continuous CAD is 1.2. The assumptions used to compute the trial size are an overall type I error rate of 0.05 and a type II error of 0.10 (power = 0.9). | Up to 15 years |
| Physical Functioning as Measured by the SF-36 | This outcome was scored on a scale of 0 to 100, with higher scores indicating better functioning. Change from Baseline in SF-36 Score at 3 Months | 3 months |
| Emotional Functioning as Measured by the SF-36 Mental Health Inventory | This outcome was scored on a scale of 0 to 100, with higher scores indicating better functioning. Change from Baseline in SF-36 Score at 3 Months | 3 months |
| Erectile Dysfunction | This outcome was assessed by having patients report whether they had erectile dysfunction (a score of 1) or no erectile dysfunction (a score of 0). This analysis looks at change from Baseline to 3 Months. | 3 months |
| High Libido | This outcome was assessed by having patients report whether their interest in sexual activities was very high, high, or moderate (a score of 1) or low or very low (a score of 0). This outcome measure is reporting a change from baseline in the percentage of participants with High Libido at 3 months. "High Libido" is defined as very high, high or moderate interest in sexual activities. | 3 months |
| Vitality |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Global Perception of Quality of Life | 15 months | |
| Social Functioning | Mean of the change in social functioning from randomization | 15 months |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma of the prostate
Metastatic stage IV (stage D2)
No suspected second primary tumors unless metastases are histologically confirmed, including special stains (e.g., prostate specific antigen [PSA] and prostatic alkaline phosphatase [PAP])
For entry into late induction therapy:
PSA at least 5 ng/mL
No acute spinal cord compression
PATIENT CHARACTERISTICS:
Age:
Performance status:
Hematopoietic:
Hepatic:
Renal:
Other:
Recovered from any major infection
No active medical illness that would preclude study or limit survival
No other malignancy within the past 5 years except:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
See Disease Characteristics
More than 1 year since any prior neoadjuvant or adjuvant hormonal therapy for a duration of no more than 4 months
More than 1 year since prior finasteride for prostate cancer for a duration of no more than 9 months (less than 6 months for benign prostatic hypertrophy)
Prior or concurrent megestrol for hot flashes allowed
No other concurrent hormonal therapy
Radiotherapy:
Surgery:
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Maha Hadi A. Hussain, MD | University of Michigan Rogel Cancer Center | Study Chair |
| Bryan J. Donnelly, MD, FRCSC, MSC | Tom Baker Cancer Centre - Calgary | Study Chair |
| Eric J. Small, MD | University of California, San Francisco | Study Chair |
| George Wilding, MD | University of Wisconsin, Madison | Study Chair |
| Atif Akdas, MD | Marmara University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tom Baker Cancer Centre - Calgary | Calgary | Alberta | T2N 4N2 | Canada | ||
| Cross Cancer Institute at University of Alberta |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22921015 | Background | Tangen CM, Hussain MH, Higano CS, Eisenberger MA, Small EJ, Wilding G, Donnelly BJ, Schelhammer PF, Crawford ED, Vogelzang NJ, Powell IJ, Thompson IM Jr. Improved overall survival trends of men with newly diagnosed M1 prostate cancer: a SWOG phase III trial experience (S8494, S8894 and S9346). J Urol. 2012 Oct;188(4):1164-9. doi: 10.1016/j.juro.2012.06.046. Epub 2012 Aug 22. | |
| Background | Hussain M, Tangen CM, Higano CS, et al.: Improved overall survival (OS) of patients (pts) with new metastatic prostate cancer (pca): better efficacy or stage migration? Data from SWOG: S9346 and 8894. [Abstract] 2010 Genitourinary Cancers Symposium, March 5-7, 2010, San Francisco, California. A-30, 2010. | ||
| 19380444 |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Combined Androgen Deprivation (CAD) | Patients receive goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily for 7 months. |
| FG001 | Continuous Hormonal Therapy | Patients continue to receive goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily until progression of disease |
| FG002 | Intermittent Hormonal Therapy | Patients are cycled between observation periods and Combined Androgen Deprivation (CAD) periods based on PSA results. Patients undergo observation in the absence of rising prostate-specific antigen (PSA) or clinical symptoms of progressive disease. Patients with rising PSA or progressive disease begin CAD therapy (goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily ). Patients whose PSA normalizes after 8 cycles of CAD treatment return to observation. Patients whose PSA does not normalize after 8 cycles of CAD treatment continue CAD therapy until progression (1 cycle of CAD treatment = 7 months with 8 injections. There are 2 injections in the first month on Days 1 and 29). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Induction |
|
| |||||||||||||||||||||||||||
| Consolidation and Randomization |
|
Randomized and eligible patients (After induction, Patients with stable or declining PSA levels of 4.0 ng per milliliter or lower at months 6 and 7 were eligible for randomization).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Continuous Hormonal Therapy | Patients continue to receive goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily until progression of disease |
| BG001 | Intermittent Hormonal Therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Overall Survival | Non-inferiority test to determine if intermittent combined androgen deprivation (CAD) overall survival is not substantially worse than continuous CAD overall survival. Specifically, the trial is designed for a one-sided test of the hypothesis that the hazard ratio of intermittent CAD to continuous CAD is 1.2. The assumptions used to compute the trial size are an overall type I error rate of 0.05 and a type II error of 0.10 (power = 0.9). | Posted | Median | 95% Confidence Interval | years | Up to 15 years |
|
Up to 10 years after registration to Induction
Participants were monitored for toxicity every 3 months while on protocol therapy or at more frequent intervals appropriate for that participant, as judged by the treating physician.
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 | Continuous Hormonal Therapy | Patients continue to receive goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily until progression of disease |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac ischemia/infarction | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Statistician | SWOG Statistical Center | 206-667-4623 |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C053541 | bicalutamide |
| D017273 | Goserelin |
| D057832 | Watchful Waiting |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
Not provided
Not provided
| NETWORK |
| European Organisation for Research and Treatment of Cancer - EORTC | NETWORK |
Not provided
Not provided
Not provided
Not provided
Not provided
| goserelin acetate |
| Drug |
Given subcutaneously |
|
| clinical observation | Other | Patients undergo observation in the absence of rising prostate-specific antigen (PSA) or clinical symptoms of progressive disease. |
|
This outcome was scored on a scale of 0 to 100, with higher scores indicating better functioning. This analysis looks at mean change from Baseline score to 3 Months. |
| 3 months |
| Role Functioning |
Mean of the change in role functioning from randomization |
| 15 months |
| General Symptoms | 15 months |
| Edmonton |
| Alberta |
| T6G 1Z2 |
| Canada |
| University of British Columbia | Vancouver | British Columbia | V5Z 1M9 | Canada |
| Nova Scotia Cancer Centre | Halifax | Nova Scotia | B3H 1V7 | Canada |
| Cancer Centre of Southeastern Ontario at Kingston General Hospital | Kingston | Ontario | K7L 5P9 | Canada |
| London Regional Cancer Program at London Health Sciences Centre | London | Ontario | N6A 4L6 | Canada |
| Ottawa Hospital Regional Cancer Centre - General Campus | Ottawa | Ontario | K1H 8L6 | Canada |
| Odette Cancer Centre at Sunnybrook | Toronto | Ontario | M4N 3M5 | Canada |
| Princess Margaret Hospital | Toronto | Ontario | M5G 2M9 | Canada |
| Hopital Notre-Dame du CHUM | Montreal | Quebec | H2L 4M1 | Canada |
| McGill Cancer Centre at McGill University | Montreal | Quebec | H2W 1S6 | Canada |
| Centre Hospitalier Universitaire de Quebec | Québec | Quebec | G1R 2J6 | Canada |
| CHUS-Hopital Fleurimont | Sherbrooke | Quebec | J1H 5N4 | Canada |
| Saskatoon Cancer Centre at the University of Saskatchewan | Saskatoon | Saskatchewan | S7N 4H4 | Canada |
| Background |
| Hussain M, Goldman B, Tangen C, Higano CS, Petrylak DP, Wilding G, Akdas AM, Small EJ, Donnelly BJ, Sundram SK, Burch PA, Dipaola RS, Crawford ED. Prostate-specific antigen progression predicts overall survival in patients with metastatic prostate cancer: data from Southwest Oncology Group Trials 9346 (Intergroup Study 0162) and 9916. J Clin Oncol. 2009 May 20;27(15):2450-6. doi: 10.1200/JCO.2008.19.9810. Epub 2009 Apr 20. |
| Background | Goldman B, Hussain M, Tangen C, et al.: Prostate-specific antigen progression (PSA-P) as a predictor of overall survival (OS) in patients (pts) with metastatic prostate cancer (PC): data from S9346 and S9916. [Abstract] American Society of Clinical Oncology 2008 Genitourinary Cancers Symposium, Feb 14-16, 2008, San Francisco, CA. A-165, 2008. |
| Background | Hussain MH, Goldman B, Tangen CM, et al.: Use of prostate-specific antigen progression (PSA-P) to predict overall survival (OS) in patients (pts) with metastatic prostate cancer (PC): data from S9346 and S9916. [Abstract] J Clin Oncol 26 (Suppl 15): A-5015, 2008. |
| Result | Hussain M, Tangen CM, Higano CS, et al.: Intermittent (IAD) versus continuous androgen deprivation (CAD) in hormone sensitive metastatic prostate cancer (HSM1PC) patients (pts): results of S9346 (INT-0162), an international phase III trial. [Abstract] J Clin Oncol 30 (Suppl 15): A-4, 2012. |
| Result | Moinpour C, Berry DL, Ely B, et al.: Preliminary quality-of-life outcomes for SWOG-9346: Intermittent androgen deprivation in patients with hormone-sensitive metastatic prostate cancer (HSM1PC)-phase III. [Abstract] J Clin Oncol 30 (Suppl 15): A-4571, 2012. |
| 16921051 | Result | Hussain M, Tangen CM, Higano C, Schelhammer PF, Faulkner J, Crawford ED, Wilding G, Akdas A, Small EJ, Donnelly B, MacVicar G, Raghavan D; Southwest Oncology Group Trial 9346 (INT-0162). Absolute prostate-specific antigen value after androgen deprivation is a strong independent predictor of survival in new metastatic prostate cancer: data from Southwest Oncology Group Trial 9346 (INT-0162). J Clin Oncol. 2006 Aug 20;24(24):3984-90. doi: 10.1200/JCO.2006.06.4246. |
| Result | Tangen CM, Hussain M, Wilding G, et al.: Determinants of prostate specific antigen (PSA) normalization in prostate cancer (PCa) patients (pts) treated with androgen deprivation (AD) on Southwest Oncology Group (SWOG) study 9346 (INT-0162). [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-1591, 2003. |
| 26720308 | Derived | Hershman DL, Unger JM, Wright JD, Ramsey S, Till C, Tangen CM, Barlow WE, Blanke C, Thompson IM, Hussain M. Adverse Health Events Following Intermittent and Continuous Androgen Deprivation in Patients With Metastatic Prostate Cancer. JAMA Oncol. 2016 Apr;2(4):453-61. doi: 10.1001/jamaoncol.2015.4655. |
| 25087673 | Derived | Eggener S. Commentary on "Intermittent versus continuous androgen deprivation in prostate cancer." Hussain M, Tangen CM, Berry DL, Higano CS, Crawford ED, Liu G, Wilding G, Prescott S, Kanaga Sundaram S, Small EJ, Dawson NA, Donnelly BJ, Venner PM, Vaishampayan UN, Schellhammer PF, Quinn DI, Raghavan D, Ely B, Moinpour CM, Vogelzang NJ, Thompson IM Jr, University of Michigan, Division of Hematology/Oncology, Ann Arbor, MI. N Engl J Med 2013; 368(14):1314-25. doi: 10.1056/NEJMoa1212299. Urol Oncol. 2014 Aug;32(6):936-7. doi: 10.1016/j.urolonc.2014.01.009. |
| 23550669 | Derived | Hussain M, Tangen CM, Berry DL, Higano CS, Crawford ED, Liu G, Wilding G, Prescott S, Kanaga Sundaram S, Small EJ, Dawson NA, Donnelly BJ, Venner PM, Vaishampayan UN, Schellhammer PF, Quinn DI, Raghavan D, Ely B, Moinpour CM, Vogelzang NJ, Thompson IM Jr. Intermittent versus continuous androgen deprivation in prostate cancer. N Engl J Med. 2013 Apr 4;368(14):1314-25. doi: 10.1056/NEJMoa1212299. |
| Progression/relapse |
|
| Death |
|
| Other |
|
| not eligible |
|
|
| Assessable for Toxicity | Patients with no AE evaluations, received wrong protocol arm, or received non-protocol trt excluded |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Patients are cycled between observation periods and Combined Androgen Deprivation (CAD) periods based on PSA results. Patients undergo observation in the absence of rising prostate-specific antigen (PSA) or clinical symptoms of progressive disease. Patients with rising PSA or progressive disease begin CAD therapy (goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily ). Patients whose PSA normalizes after 8 cycles of CAD treatment return to observation. Patients whose PSA does not normalize after 8 cycles of CAD treatment continue CAD therapy until progression (1 cycle of CAD treatment = 7 months with 8 injections. There are 2 injections in the first month on Days 1 and 29).
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Consolidation Arm II |
Patients undergo observation in the absence of rising prostate-specific antigen (PSA) or clinical symptoms of progressive disease. Patients with rising PSA or progressive disease begin CAD therapy as in consolidation arm I. Patients whose PSA normalizes after 8 courses return to observation. Patients whose PSA does not normalize after 8 courses continue CAD therapy. bicalutamide: Given orally goserelin acetate: Given subcutaneously clinical observation: Patients undergo observation in the absence of rising prostate-specific antigen (PSA) or clinical symptoms of progressive disease. |
|
|
|
| Primary | Physical Functioning as Measured by the SF-36 | This outcome was scored on a scale of 0 to 100, with higher scores indicating better functioning. Change from Baseline in SF-36 Score at 3 Months | Only eligible patients with a usable form set for Physical Functioning portion of the SF-36 both at baseline and 3 months were included in this analysis. | Posted | Mean | Standard Error | units on a scale | 3 months |
|
|
|
|
| Primary | Emotional Functioning as Measured by the SF-36 Mental Health Inventory | This outcome was scored on a scale of 0 to 100, with higher scores indicating better functioning. Change from Baseline in SF-36 Score at 3 Months | Only eligible patients with a usable form set for SF-36 Mental Health Inventory both at baseline and 3 months were included in this analysis. | Posted | Mean | Standard Error | units on a scale | 3 months |
|
|
|
|
| Primary | Erectile Dysfunction | This outcome was assessed by having patients report whether they had erectile dysfunction (a score of 1) or no erectile dysfunction (a score of 0). This analysis looks at change from Baseline to 3 Months. | Only eligible patients with a usable answers regarding erectile dysfunction both at baseline and 3 months were included in this analysis. | Posted | Number | percentage of participants | 3 months |
|
|
|
|
| Primary | High Libido | This outcome was assessed by having patients report whether their interest in sexual activities was very high, high, or moderate (a score of 1) or low or very low (a score of 0). This outcome measure is reporting a change from baseline in the percentage of participants with High Libido at 3 months. "High Libido" is defined as very high, high or moderate interest in sexual activities. | Only eligible patients with a usable answers regarding libido both at baseline and 3 months were included in this analysis. | Posted | Number | percentage of participants | 3 months |
|
|
|
|
| Primary | Vitality | This outcome was scored on a scale of 0 to 100, with higher scores indicating better functioning. This analysis looks at mean change from Baseline score to 3 Months. | Only eligible patients with a usable form set for Vitality both at baseline and 3 months were included in this analysis. | Posted | Mean | Standard Error | units on a scale | 3 months |
|
|
|
|
| Other Pre-specified | Global Perception of Quality of Life | Not Posted | 15 months | Participants |
| Other Pre-specified | Social Functioning | Mean of the change in social functioning from randomization | Not Posted | 15 months | Participants |
| Other Pre-specified | Role Functioning | Mean of the change in role functioning from randomization | Not Posted | 15 months | Participants |
| Other Pre-specified | General Symptoms | Not Posted | 15 months | Participants |
| 19 |
| 732 |
| 665 |
| 732 |
| EG001 | Intermittent Hormonal Therapy | Patients are cycled between observation periods and Combined Androgen Deprivation (CAD) periods based on PSA results. Patients undergo observation in the absence of rising prostate-specific antigen (PSA) or clinical symptoms of progressive disease. Patients with rising PSA or progressive disease begin CAD therapy (goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily ). Patients whose PSA normalizes after 8 cycles of CAD treatment return to observation. Patients whose PSA does not normalize after 8 cycles of CAD treatment continue CAD therapy until progression (1 cycle of CAD treatment = 7 months with 8 injections. There are 2 injections in the first month on Days 1 and 29). | 10 | 702 | 609 | 702 |
| Cardiovascular-other | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
|
| LVEF decrease/CHF | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
|
| Flu-like symptoms-other | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| Second primary | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (2.0) | Systematic Assessment |
|
| Cerebrovascular ischemia | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Lung-other | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Pleural effusions | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Hemorrhage-other | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
|
| Thrombosis/embolism | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
|
| Constipation/bowel obstruction | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Diarrhea without colostomy | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Fatigue/malaise/lethargy | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| Pain-other | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| Alkaline phosphatase increase | Investigations | CTCAE (2.0) | Systematic Assessment |
|
| Creatinine increase | Investigations | CTCAE (2.0) | Systematic Assessment |
|
| SGOT (AST) increase | Investigations | CTCAE (2.0) | Systematic Assessment |
|
| Weight gain | Investigations | CTCAE (2.0) | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| Dizziness/light headedness | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Sensory neuropathy | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Weakness (motor neuropathy) | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Anxiety/agitation | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
|
| Libido loss | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
|
| Urinary frequency/urgency | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
|
| Erectile impotence | Reproductive system and breast disorders | CTCAE (2.0) | Systematic Assessment |
|
| Gynecomastia | Reproductive system and breast disorders | CTCAE (2.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| Sweating | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| Hot flashes | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
|
Not provided
Not provided
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |