Prostatectomy Compared With Watchful Waiting in Treating Patients With Stage I or Stage II Prostate Cancer

RATIONALE: Watchful waiting until symptoms appear may be effective in patients with prostate cancer. It is not yet known if watchful waiting is more effective than prostatectomy for early prostate cancer.

Official Title

NCI HIGH PRIORITY CLINICAL TRIAL — Phase III Randomized Study of Prostatectomy Versus Expectant Management With Palliative Therapy in Patients With Clinically Localized Prostate Cancer (PIVOT)

Conditions

– adenocarcinoma of the prostate- stage I prostate cancer- stage II prostate cancer

Study Type

Interventional

Study Design

Treatment

Further Details

PURPOSE: Randomizedphase III trial to compare surgery with watchful waiting in men who have stage I or stage II prostate cancer.OBJECTIVES:Compare the overall mortality rate in patients with clinically localized prostate cancer treated with radical prostatectomy and early intervention for subsequent disease progression vs expectant management with therapy reserved for palliation of symptomatic or metastatic disease. Compare the prostate cancer-specific survival of patients treated with these regimens. Compare the quality of life of patients treated with these regimens. Compare the progression-free survival of patients treated with these regimens. Determine the effects of radical prostatectomy on disease recurrence in these patients. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.Arm I: Within 6 weeks after randomization, patients undergo pelvic lymph node dissection (at the discretion of the urologist) followed within 2 weeks by radical prostatectomy. The choice of surgical procedure (retropubic, perineal, nerve sparing, or nonnerve sparing) is at the discretion of the urologist. Patients with metastases may undergo standard therapy, including prostatectomy, observation, orchiectomy or hormonal therapy, or radiotherapy. Patients with disease progression may undergo standard therapy, including hormonal therapy, radiotherapy, mechanical intervention, or observation. Arm II: Patients undergo expectant management with interventions reserved for symptomatic or metastatic disease. Asymptomatic disease progression (e.g., enlarging mass on digital rectal exam or imaging study, increase in PSA) without evidence of metastatic disease is not considered an indication for intervention. Patients with symptomatic local progression are treated first with alpha blockers or mechanical intervention (e.g., transurethral resection of the prostate (TURP), transurethral incision of the prostate, stent placement). Patients with symptomatic regional progression undergo mechanical intervention, radiotherapy, or hormonal therapy, as indicated. Hormonal therapy is considered first-line therapy for patients with disease progression requiring nonmechanical therapy. Patients with disease that continues to progress or fails to respond to hormonal therapy undergo radiotherapy or chemotherapy. Patients with symptomatic local disease progression (defined as recurrent and persistent gross hematuria or bladder outlet obstruction) despite TURP, stents, and alpha blockers may undergo prostatectomy. Quality of life is assessed at baseline and then every 6 months. Patients are followed every 3 months for 1 year and then every 6 months for 15 years.PROJECTED ACCRUAL: A total of 1,050 patients will be accrued for this study within 7 years.

Study Start

Eligibility & Criteria

Ages Eligible for Study: up to 75 Years, Genders Eligible for Study: Both Criteria DISEASE CHARACTERISTICS:Adenocarcinoma of the prostate diagnosed within the past year Clinically localized disease (T1a-c or T2a-c, NX, M0) PSA no greater than 50 ng/mL No evidence of metastatic disease on bone scan No evidence of nonlocalized disease on other imaging studies PATIENT CHARACTERISTICS: Age:75 and under Performance status:Not specified Life expectancy:At least 10 years Hematopoietic:Not specified Hepatic:No severe hepatic impairment Renal:Creatinine no greater than 3.0 mg/dL No severe renal impairment Cardiovascular:No New York Heart Association class III or IV heart disease No myocardial infarction within the past 6 months No unstable angina No other severe cardiac impairment Pulmonary:No severe pulmonary impairment Other:No other significant concurrent medical condition that is acute or debilitating or would increase risk No dementia No nondermatologic malignancy within the past 5 years PRIOR CONCURRENT THERAPY: Biologic therapy:Not specified Chemotherapy:No prior chemotherapy for prostate cancer Endocrine therapy:No prior hormonal therapy for prostate cancer No concurrent estrogens or antiandrogens Radiotherapy:No prior radiotherapy for prostate cancer Surgery:No prior surgery for prostate cancer except transurethral resection Other:No concurrent participation in another intervention research study

Total Enrolment

1050

Contact Details

[1] Westmead Hospital, Westmead, New South Wales, 2145, Australia[2] Department of Veterans Affairs Cooperative Studies Program[3] National Cancer Institute (NCI)[4] Cancer and Leukemia Group B[5] Southwest Oncology Group[6] Eastern Cooperative Oncology Group