Prostate Cancer Clinical Trial
Official title:
Intermittent Androgen Deprivation in Patients With Stage D2 Prostate Cancer, Phase III
Verified date | April 2009 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | Unspecified |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 1512 |
Est. completion date | |
Est. primary completion date | June 2013 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed adenocarcinoma of the prostate - Metastatic stage IV (stage D2) - Any number of bone metastases by bone scan allowed - Unequivocal visceral organ metastases (liver, brain, or lung) allowed - 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: - No more than 1 month from the beginning of antiandrogen therapy to the beginning of luteinizing hormone-releasing hormone (LHRH) agonist therapy - No more than 6 months since initiation of current combined androgen-deprivation therapy (LHRH agonist and antiandrogen) - The effectiveness of the current depot LHRH agonist would not extend beyond 8 months after initiation of combined androgen therapy - PSA at least 5 ng/mL - No acute spinal cord compression PATIENT CHARACTERISTICS: Age: - Adult Performance status: - SWOG 0-2 Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Not specified 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: - Adequately treated basal cell or squamous cell skin cancer - Adequately treated carcinoma in situ of the bladder - Adequately treated other superficial cancer PRIOR CONCURRENT THERAPY: Biologic therapy: - No concurrent biological response modifier therapy Chemotherapy: - No concurrent 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 - Single or combination therapy allowed - 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: - No concurrent radiotherapy other than palliation of painful bone metastases Surgery: - No prior bilateral orchiectomy - Recovered from any prior major surgery |
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Tom Baker Cancer Centre - Calgary | Calgary | Alberta |
Canada | Cross Cancer Institute at University of Alberta | Edmonton | Alberta |
Canada | Nova Scotia Cancer Centre | Halifax | Nova Scotia |
Canada | Cancer Centre of Southeastern Ontario at Kingston General Hospital | Kingston | Ontario |
Canada | London Regional Cancer Program at London Health Sciences Centre | London | Ontario |
Canada | Hopital Notre-Dame du CHUM | Montreal | Quebec |
Canada | McGill Cancer Centre at McGill University | Montreal | Quebec |
Canada | Ottawa Hospital Regional Cancer Centre - General Campus | Ottawa | Ontario |
Canada | Centre Hospitalier Universitaire de Quebec | Quebec City | Quebec |
Canada | Saskatoon Cancer Centre at the University of Saskatchewan | Saskatoon | Saskatchewan |
Canada | CHUS-Hopital Fleurimont | Sherbrooke | Quebec |
Canada | Odette Cancer Centre at Sunnybrook | Toronto | Ontario |
Canada | Princess Margaret Hospital | Toronto | Ontario |
Canada | University of British Columbia | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
Southwest Oncology Group | Canadian Cancer Trials Group, Cancer and Leukemia Group B, Eastern Cooperative Oncology Group, European Organisation for Research and Treatment of Cancer - EORTC, National Cancer Institute (NCI) |
Canada,
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.
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. — View Citation
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 — View Citation
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.
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 C
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.
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, 201
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] Proc
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Treatment-specific symptoms as measured on the four-item Medical Outcomes Study Short Form-36 (SF-36) and Vitality scale | No | ||
Primary | Physical functioning as measured by the SF-36 | No | ||
Primary | Emotional functioning as measured by the SF-36 Mental Health Inventory | No | ||
Secondary | Symptoms as assessed by the Symptom Distress Scale | No | ||
Secondary | Role functioning as assessed by the Role Functioning Scale SF-20 | No | ||
Secondary | Social functioning as assessed by the General Health Survey SF-20 | No | ||
Secondary | Global quality of life (QOL) and health-related QOL | No | ||
Secondary | Comorbidity, social support, and demographic variables | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05540392 -
An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues
|
Phase 1/Phase 2 | |
Recruiting |
NCT05613023 -
A Trial of 5 Fraction Prostate SBRT Versus 5 Fraction Prostate and Pelvic Nodal SBRT
|
Phase 3 | |
Recruiting |
NCT05156424 -
A Comparison of Aerobic and Resistance Exercise to Counteract Treatment Side Effects in Men With Prostate Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT03177759 -
Living With Prostate Cancer (LPC)
|
||
Completed |
NCT01331083 -
A Phase II Study of PX-866 in Patients With Recurrent or Metastatic Castration Resistant Prostate Cancer
|
Phase 2 | |
Recruiting |
NCT05540782 -
A Study of Cognitive Health in Survivors of Prostate Cancer
|
||
Active, not recruiting |
NCT04742361 -
Efficacy of [18F]PSMA-1007 PET/CT in Patients With Biochemial Recurrent Prostate Cancer
|
Phase 3 | |
Completed |
NCT04400656 -
PROState Pathway Embedded Comparative Trial
|
||
Completed |
NCT02282644 -
Individual Phenotype Analysis in Patients With Castration-Resistant Prostate Cancer With CellSearch® and Flow Cytometry
|
N/A | |
Recruiting |
NCT06305832 -
Salvage Radiotherapy Combined With Androgen Deprivation Therapy (ADT) With or Without Rezvilutamide in the Treatment of Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer
|
Phase 2 | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT05761093 -
Patient and Physician Benefit/ Risk Preferences for Treatment of mPC in Hong Kong: a Discrete Choice Experiment
|
||
Completed |
NCT04838626 -
Study of Diagnostic Performance of [18F]CTT1057 for PSMA-positive Tumors Detection
|
Phase 2/Phase 3 | |
Recruiting |
NCT03101176 -
Multiparametric Ultrasound Imaging in Prostate Cancer
|
N/A | |
Completed |
NCT03290417 -
Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Prostate Cancer
|
N/A | |
Completed |
NCT00341939 -
Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
|
||
Completed |
NCT01497925 -
Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer
|
Phase 1 | |
Recruiting |
NCT03679819 -
Single-center Trial for the Validation of High-resolution Transrectal Ultrasound (Exact Imaging Scanner ExactVu) for the Detection of Prostate Cancer
|
||
Completed |
NCT03554317 -
COMbination of Bipolar Androgen Therapy and Nivolumab
|
Phase 2 | |
Completed |
NCT03271502 -
Effect of Anesthesia on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy
|
N/A |