Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information
Registry Information

Alternate Title

NCI HIGH PRIORITY CLINICAL TRIAL --- Prostatectomy Compared With Watchful Waiting in Treating Patients With Stage I or Stage II Prostate Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Closed 75 and under NCI VA-CSP-407 CALGB-9492, ECOG-VA407, SWOG-9450, PIVOT-1, NCI-T94-0131O, NCT00002606, T94-0131

Objectives

1. 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.
2. Compare the prostate cancer-specific survival of patients treated with these regimens.
3. Compare the quality of life of patients treated with these regimens.
4. Compare the progression-free survival of patients treated with these regimens.
5. Determine the effects of radical prostatectomy on disease recurrence in these patients.

Entry 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

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

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

Expected Enrollment

A total of 1,050 patients will be accrued for this study within 7 years.

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.

Wilt TJ, Brawer MK: The Prostate Cancer Intervention Versus Observation Trial (PIVOT). Oncology (Huntingt) 11 (8): 1133-9; discussion 1139-40, 1143, 1997.[PUBMED Abstract]

Moon TD, Brawer MK, Wilt TJ: Prostate Intervention Versus Observation Trial (PIVOT): a randomized trial comparing radical prostatectomy with palliative expectant management for treatment of clinically localized prostate cancer. PIVOT Planning Committee. J Natl Cancer Inst Monogr (19): 69-71, 1995.[PUBMED Abstract]

Wilt TJ, Brawer MK: Early intervention or expectant management for prostate cancer. The Prostate Cancer Intervention Versus Observation Trial (PIVOT): a randomized trial comparing radical prostatectomy with expectant management for the treatment of clinically localized prostate cancer. Semin Urol 13 (2): 130-6, 1995.[PUBMED Abstract]

Wilt TJ, Brawer MK: The prostate cancer intervention versus observation trial (PIVOT): a randomized trial comparing radical prostectomy versus expectant management for the treatment of clinically localized prostate cancer. Cancer 75(7 Suppl): 1963-1968, 1995.

Wilt TJ, Brawer MK: The Prostate Cancer Intervention Versus Observation Trial: a randomized trial comparing radical prostatectomy versus expectant management for the treatment of clinically localized prostate cancer. J Urol 152 (5 Pt 2): 1910-4, 1994.[PUBMED Abstract]

Screening for prostate cancer. American College of Physicians. Ann Intern Med 126 (6): 480-4, 1997.[PUBMED Abstract]

Wilt TJ: Expectant management or early intervention of clinically localized prostate cancer? What we need are randomized trials. Clinical Care for Prostatic Diseases 1 : 1-9, 1994.

Trial Contact Information

Trial Lead Organizations

Veterans Affairs Cooperative Studies Program Coordinating Center - Perry Point

Timothy James Wilt, MD, MPH, Protocol chair		Ph: 612-725-2158; 866-414-5058 Email: wilt.timothy@minneapolis.va.gov

Cancer and Leukemia Group B

Timothy James Wilt, MD, MPH, Protocol chair		Ph: 612-725-2158; 866-414-5058 Email: wilt.timothy@minneapolis.va.gov

Southwest Oncology Group

Daniel Culkin, MD, FACS, Protocol chair(Contact information may not be current)		Ph: 405-271-6673

Eastern Cooperative Oncology Group

Timothy Moon, MD, FRCSC, MBChB, Protocol chair		Ph: 608-262-0475; 800-283-2881 ext. 2866 Email: moon@surgery.wisc.edu

Registry Information
Official Title		PROSTATE CANCER INTERVENTION VERSUS OBSERVATION TRIAL (PIVOT): A RANDOMIZED TRIAL COMPARING RADICAL PROSTATECTOMY VERSUS PALLIATIVE EXPECTANT MANAGEMENT FOR THE TREATMENT OF CLINICALLY LOCALIZED PROSTATE CANCER
Registered in ClinicalTrials.gov		NCT00002606
Date Submitted to PDQ		1994-12-01
Information Last Verified		2003-04-18