|Phase III||Treatment||Completed||Under 80||NCI, Other||PR3|
CAN-NCIC-PR3, ECOG-JPR03, MRC-PR07, SWOG-JPR3, EU-99013, NCI-T94-0110O, ISRCTN24991896, CDR0000064065, CALGB-9593, T94-0110, NCT00002633
RATIONALE: Hormones can stimulate the growth of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether hormone therapy plus surgery is more effective than hormone therapy plus radiation therapy for prostate cancer.
PURPOSE: This randomized phase III trial is studying giving hormone therapy alone to see how well it works compared to giving hormone therapy together with bilateral orchiectomy or radiation therapy in treating patients with stage III or stage IV prostate cancer.
Further Study Information
- Compare the overall survival, disease specific survival, and time to progression in patients with locally advanced adenocarcinoma of the prostate treated with total androgen suppression with or without pelvic irradiation.
- Compare the symptomatic control as measured by the rates of surgical interventions needed for control of local disease (e.g., transurethral resections, stent insertions, nephrostomies, and colostomies) in patients treated with these regimens.
- Compare the quality of life of patients treated with these regimens.
- Compare the sensitivity of the EORTC-QLQ-C30+3 and a trial-specific checklist (PR17) with the FACT-P questionnaire in measuring changes in quality of life of patients treated with these regimens.
OUTLINE: This a randomized, multicenter study. Patients are stratified according to center, initial PSA level (less than 20 vs 20-50 vs greater than 50 ng/mL), method of node staging (clinical [no CT scan] vs radiological [CT scan negative] vs surgical), Gleason score (less than 8 vs 8-10), prior hormonal therapy (excluding orchiectomy) (yes vs no), and choice of hormonal therapy (bilateral orchiectomy with or without antiandrogen vs luteinizing hormone-releasing hormone [LHRH] with antiandrogen). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive antiandrogen therapy comprising oral flutamide every 8 hours, oral nilutamide every 8 hours for 1 month and then once daily, or oral bicalutamide once daily. Patients also choose to undergo bilateral orchiectomy or LHRH agonist therapy comprising goserelin subcutaneously (SC) every 4 weeks (short-acting formulation) or every 3 months (long-acting formulation), leuprolide intramuscularly every 4 weeks (short-acting formulation) or every 3 months (long-acting formulation), or buserelin SC every 8 weeks or every 12 weeks. Patients choosing orchiectomy may receive an antiandrogen for at least 6 weeks before surgery to counter any flare phenomenon and may continue the antiandrogen after surgery (at the physician's discretion).
- Arm II: Patients undergo total androgen ablation as in arm I. Patients with node-negative dissection undergo radiotherapy 5 days a week for 6.5-7 weeks. All other patients undergo radiotherapy 5 days a week for 5 weeks, followed by boost radiotherapy 5 days a week for 2-2.4 weeks.
Hormonal therapy on both arms continues in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, on the last day of radiotherapy, at 6 months, and then every 6 months thereafter.
Patients are followed at 1, 2, and 6 months and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 1,200 patients will be accrued for this study within 7.5 years.
- Histologically proven locally advanced adenocarcinoma of the prostate, defined as 1 of the following:
- T3-4, N0 or NX, M0
- T2, PSA greater than 40 µg/L
- T2, PSA greater than 20 µg/L AND Gleason score at least 8
- Diagnosis made within the past 6 months
- Gleason score and PSA known
- Pelvic lymph nodes must be clinically negative
- Lymph nodes no more than 1.5 cm in greatest diameter by CT scan or MRI of the pelvis
- Negative needle aspirate required for any lymph node more than 1.5 cm
- If a lymph node dissection was performed, it must be histologically negative
- No small cell or transitional cell carcinoma by biopsy
- No bony metastases by bone scan
- Under 80
- ECOG 0-2
- At least 5 years excluding malignancy
- Hemoglobin at least 10.0 g/dL
- WBC at least 2,000/mm^3
- Platelet count at least 100,000/mm^3
- Bilirubin less than 2 times upper limit of normal (ULN)
- SGOT and SGPT less than 2 times ULN
- Alkaline phosphatase less than 2 times ULN
- No history of chronic liver disease
- Creatinine less than 2 times ULN
- No contraindication to wide-field pelvic irradiation (e.g., inflammatory bowel disease or severe bladder irritability)
- No other malignancy within the past 5 years except nonmelanoma skin cancer
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- Not specified
- Not specified
- Prior hormonal therapy within the past 12 weeks allowed provided the following conditions are met:
- Negative bone scan before beginning any hormonal therapy
- Extracapsular extension remains palpable on rectal re-exam
- Baseline PSA known before beginning any hormonal therapy
- At least 4-6 weeks since prior 5-alpha-reductase inhibitor (e.g., finasteride) for benign prostatic hypertrophy
- No prior pelvic irradiation
- No prior radical prostatectomy
- Prior transurethral resection of the prostate allowed
- No prior cytotoxic anticancer therapy
- No other prior treatment for prostate cancer
- No other concurrent anticancer therapy unless documented disease progression
Trial Lead Organizations/Sponsors
NCIC-Clinical Trials GroupNational Cancer Institute
Eastern Cooperative Oncology Group
Southwest Oncology Group
Medical Research Council's Working Party on Leukemia in Adults and Children
|Padraig R. Warde||Study Chair|
|Richard R. Whittington||Study Chair|
|Srinivasan Vijayakumar||Study Chair|
|Patricia Lillis-Hearne||Study Chair|
|Malcolm D. Mason||Study Chair|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00002633
ClinicalTrials.gov processed this data on September 30, 2013
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