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.

PURPOSE: Randomizedphase III trial to compare surgery with watchful waiting in men who have stage I or stage II prostate cancer.

Condition	Treatment or Intervention	Phase
adenocarcinoma of the prostate stage I prostate cancer stage II prostate cancer	Procedure: chemotherapy  Procedure: conventional surgery  Procedure: endocrine therapy  Procedure: hormone therapy  Procedure: radiation therapy  Procedure: surgery	Phase III

Further Study Details: 

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.

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

Iowa
      Iowa Lutheran Hospital, Des Moines,  Iowa,  50316-2301,  United States
      John Stoddard Cancer Center at Iowa Methodist Medical Center, Des Moines,  Iowa,  50309,  United States
      Mercy Cancer Center at Mercy Medical Center-Des Moines, Des Moines,  Iowa,  50314,  United States
Nebraska
      Midlands Cancer Center at Midlands Community Hospital, Papillion,  Nebraska,  68128-4157,  United States
New Mexico
      MBCCOP - University of New Mexico HSC, Albuquerque,  New Mexico,  87131,  United States
Pennsylvania
      Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey,  Pennsylvania,  17033-0850,  United States
Wisconsin
      CCOP - St. Vincent Hospital Cancer Center, Green Bay, Green Bay,  Wisconsin,  54307-3453,  United States
      University of Wisconsin Comprehensive Cancer Center, Madison,  Wisconsin,  53792-3236,  United States
Australia, New South Wales
      Westmead Hospital, Westmead,  New South Wales,  2145,  Australia
Peru
      Instituto de Enfermedades Neoplasicas, Lima,  34,  Peru
Puerto Rico
      San Juan City Hospital, San Juan,  00936-7344,  Puerto Rico

Study chairs or principal investigators

Timothy James Wilt, MD, MPH,  Study Chair,  Veterans Affairs Medical Center - Minneapolis   
Timothy James Wilt, MD, MPH,  Study Chair,  Veterans Affairs Medical Center - Minneapolis   
Daniel J. Culkin, MD, FACS,  Study Chair,  Oklahoma Medical Research Foundation   
Timothy David Moon, MD,  Study Chair,  University of Wisconsin Comprehensive Cancer Center   

Study ID Numbers:  CDR0000063882; VA-CSP-407; CALGB-9492; ECOG-VA407; SWOG-9450; PIVOT-1; NCI-T94-0131O
Record last reviewed:  September 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002606
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08