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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)
Alternate Title NCI HIGH PRIORITY CLINICAL TRIAL --- Prostatectomy Compared With Watchful Waiting in Treating Patients With Stage I or Stage II Prostate Cancer
Objectives
Entry Criteria Disease Characteristics:
Prior/Concurrent Therapy: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Patient Characteristics: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
Expected Enrollment 1050A 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.
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. Published ResultsWilt TJ, Brawer MK, Barry MJ, et al.: The Prostate cancer Intervention Versus Observation Trial:VA/NCI/AHRQ Cooperative Studies Program #407 (PIVOT): design and baseline results of a randomized controlled trial comparing radical prostatectomy to watchful waiting for men with clinically localized prostate cancer. Contemp Clin Trials 30 (1): 81-7, 2009.[PUBMED Abstract] 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] Related PublicationsScreening 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 Lead Organizations Veterans Affairs Cooperative Studies Program Coordinating Center - Perry Point
Cancer and Leukemia Group B
Southwest Oncology Group
Eastern Cooperative Oncology Group
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
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