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

Sponsor:	Department of Veterans Affairs
Collaborators:	National Cancer Institute (NCI) Cancer and Leukemia Group B Southwest Oncology Group Eastern Cooperative Oncology Group
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00002606

Purpose

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

Condition	Intervention	Phase
Prostate Cancer	Drug: chemotherapy Drug: endocrine-modulating drug therapy Procedure: conventional surgery Radiation: radiation therapy	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer Surgery

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:

1050

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	up to 75 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002606

Locations

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

Sponsors and Collaborators

Department of Veterans Affairs

National Cancer Institute (NCI)

Cancer and Leukemia Group B

Southwest Oncology Group

Eastern Cooperative Oncology Group

Investigators

Study Chair:	Timothy James Wilt, MD, MPH	Veterans Affairs Medical Center - Minneapolis
Study Chair:	Timothy James Wilt, MD, MPH	Veterans Affairs Medical Center - Minneapolis
Study Chair:	Daniel J. Culkin, MD, FACS	Oklahoma Medical Research Foundation
Study Chair:	Timothy D. Moon, MD, FRCSC, MBChB	University of Wisconcin Cancer Center at Aspirus Wausau Hospital

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Wilt TJ, Brawer MK, Barry MJ, Jones KM, Kwon Y, Gingrich JR, Aronson WJ, Nsouli I, Iyer P, Cartagena R, Snider G, Roehrborn C, Fox S. 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. 2009 Jan;30(1):81-7. Epub 2008 Aug 23.

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

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. 1995;(19):69-71. No abstract available.

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. 1995 May;13(2):130-6. No abstract available.

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. 1994 Nov;152(5 Pt 2):1910-4.

[No authors listed] Screening for prostate cancer. American College of Physicians. Ann Intern Med. 1997 Mar 15;126(6):480-4. Review. No abstract available.

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.

Study ID Numbers:	CDR0000063882, VA-CSP-407, CALGB-9492, ECOG-VA407, SWOG-9450, PIVOT-1, NCI-T94-0131O
Study First Received:	November 1, 1999
Last Updated:	July 25, 2009
ClinicalTrials.gov Identifier:	NCT00002606 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009