androgen deprivation therapy in treating patients with prostate cancer

Conditions: Prostate Cancer

Summary: rationale: androgens can cause the growth of prostate cancer cells. androgen deprivation therapy may stop the adrenal glands from making androgens. purpose: this randomized phase iii trial is studying how well androgen deprivation therapy works in treating patients with prostate cancer.

objectives: primary * compare overall survival (with acceptable morbidity) of patients with prostate cancer treated with delayed vs immediate androgen deprivation therapy (adt). secondary * compare cancer-specific survival of patients treated with these regimens. * compare clinical progression in patients treated with these regimens. * compare time to first androgen independence in patients treated with these regimens. * compare complication rate incidence and timing (e.g., cord compression or pathological failure) in patients treated with these regimens. * compare treatment-related morbidity (including cognitive morbidity or osteoporosis) in patients treated with these regimens. * compare quality of life of patients treated with these regimens. * determine prognostic factors for progression in patients treated with delayed adt. outline: this is a multicenter, randomized, controlled study. patients in group 1 are stratified according to prior therapy (prostatectomy vs radiotherapy vs prostatectomy and radiotherapy), relapse-free interval (\< 2 years vs ≥ 2 years), type of planned androgen deprivation therapy (adt) (continuous vs intermittent), and participating center. patients in group 2 are stratified according to type of planned adt (continuous vs intermittent), disease type (localized vs metastatic), and participating center. patients in both groups are randomized to 1 of 2 treatment arms. * arm i (delayed adt): beginning at least 2 years after study entry or after exhibiting evidence of significant disease progression\*, patients receive either continuous adt or intermittent adt comprising either bilateral orchiectomy or luteinizing hormone-releasing hormone agonist with or without oral antiandrogen therapy. * arm ii (immediate adt): beginning immediately after randomization, patients receive either continuous adt or intermittent adt as in arm i. note: \*patients in group 1 begin delayed adt at least 2 years after study entry unless 1 of the following clinical criteria is present: prostate-specific antigen (psa) doubling time of \< 12 months with psa ≥ 10 ng/ml or psa doubling time of ≤ 6 months based on 3 consecutive measurements obtained ≥ 2 months apart or development of metastases or symptoms. patients in group 2 begin delayed adt at least 2 years after study entry unless 1 of the following clinical criteria is present: development of symptoms or psa ≥ 60 ng/ml or psa doubling time of ≤ 6 months based on 3 consecutive measurements obtained ≥ 2 months apart. after 9 months of adt, all patients are assessed for response. patients with psa \ 20 ng/ml or psa is \> the psa level at study entry or at clinical progression. quality of life is assessed at baseline, every 6 months for 2 years, and then annually for 3 years. patients are followed every 3 months for 2 years, every 6 months for 3 years, and then periodically thereafter at the discretion of the principal investigator. projected accrual: a total of 300-2,000 patients will be accrued for this study within 2-5 years.

Eligibility criteria:
disease characteristics: * histologically confirmed adenocarcinoma of the prostate * prostate-specific antigen (psa) relapse or incurable disease diagnosed within the past 2 months and meets criteria for either of the following groups: * group 1 * in psa relapse after definitive radical treatment (prostatectomy or radiotherapy), as evidenced by 1 the following: * post-prostatectomy psa level ≥ 0.2 ng/ml * at least 3 rising psa levels (post-radiotherapy) obtained ≥ 1 month apart, with the last psa obtained within the past 2 months * no metastatic disease by bone scan or abdomino-pelvic ct scan * group 2 * not suitable for radical treatment at primary diagnosis * not planning to receive curative treatment * localized or metastatic disease * no symptomatic disease requiring radiotherapy or immediate hormonal therapy * no symptomatic disease requiring therapy patient characteristics: age * any age performance status * not specified life expectancy * at least 5 years hematopoietic * not specified hepatic * not specified renal * not specified other * no other significant comorbid condition that would limit life expectancy to \< 5 years prior concurrent therapy: biologic therapy * not specified chemotherapy * not specified endocrine therapy * at least 12 months since prior androgen deprivation therapy (adt) administered in the neoadjuvant or concurrent (with radiotherapy) setting (group 1) * no prior adt (group 2) radiotherapy * see disease characteristics * see endocrine therapy surgery * see disease characteristics other * no concurrent enrollment in trog-96.01 or trog-radar protocols

Keywords: adenocarcinoma of the prostate stage i prostate cancer stage iib prostate cancer stage iia prostate cancer stage iii prostate cancer stage iv prostate cancer recurrent prostate cancer