Prostate Cancer Intervention Versus Observation Trial (PIVOT)

Prostate Cancer Clinical Trial

— PIVOT  

Official title:

CSP #407 - 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00007644
• Other study ID #: 407
• Status: Completed
• Phase: Phase 3
• Start date: November 1994
• Est. completion date: January 2010

Study information

• Verified date: February 2020
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Radical prostatectomy provides potentially curative removal of the cancer. However, it subjects patients to the morbidity and mortality of the surgery and may be neither necessary nor effective. Expectant management does not offer potential cure. However, it provides palliative therapy for symptomatic or metastatic disease progression, avoids potentially excessive and morbid interventions in asymptomatic patients, and emphasizes management approaches for focus on relieving symptoms while minimizing therapeutic complications.

The primary objective of this study is to determine which of two strategies is superior for the management of clinically localized CAP: 1) radical prostatectomy with early aggressive intervention for disease persistence or recurrence, 2) expectant management with reservation of therapy for palliative treatment of symptomatic or metastatic disease progression. Outcomes include total mortality, CAP mortality, disease free and progression free survival, morbidity, quality of life, and cost effectiveness.

Description:

Primary Hypothesis: To determine whether radical prostatectomy or expectant management is more effective in reducing mortality and extending life.

Secondary Hypothesis: To determine which treatment strategy is superior in terms of prostate specific cancer mortality, quality of life, occurrence or recurrence of symptoms and need for cancer treatment.

Intervention: 1) Radical prostatectomy, plus intervention for evidence of disease persistence or recurrence, 2) Expectant management with palliative therapy reserved for symptomatic or metastatic disease progression.

Primary Outcomes: All cause mortality.

Study Abstract: Cancer of the prostate (CAP) is the most common nondermatologic and the second most frequent cause of cancer deaths in men. No cure is currently possible for disseminated disease. Cancer confined to the prostate is believed to be curable, with the most frequently recommended therapy being surgical extirpation of the tumor with radical prostatectomy. However, despite increasing cancer detection and aggressive surgical treatment, population-based mortality rates from prostate cancer have not decreased, neither nationally nor in states with high rates of radical prostatectomy. Existing evidence does not demonstrate the superiority of this procedure compared to expectant management in the treatment of localized prostate cancer. Data from case series suggest that either treatment approach provides equivalent all-cause as well as prostate cancer specific mortality. The only randomized trial was limited by a small sample size but the results favored expectant management.

Radical prostatectomy provides potentially curative removal of the cancer. However, it subjects patients to the morbidity and mortality of the surgery and may be neither necessary nor effective. Expectant management does not offer potential cure. However, it provides palliative therapy for symptomatic or metastatic disease progression, avoids potentially excessive and morbid interventions in asymptomatic patients, and emphasizes management approaches for focus on relieving symptoms while minimizing therapeutic complications.

The primary objective of this study is to determine which of two strategies is superior for the management of clinically localized CAP: 1) radical prostatectomy with early aggressive intervention for disease persistence or recurrence, 2) expectant management with reservation of therapy for palliative treatment of symptomatic or metastatic disease progression. Outcomes include total mortality, CAP mortality, disease free and progression free survival, morbidity, quality of life, and cost effectiveness.

Other known NCT identifiers

• NCT00002606

Recruitment information / eligibility

• Status: Completed
• Enrollment: 731
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A to 75 Years

Eligibility

Inclusion Criteria:

• Patients with clinically localized CAP

• Diagnosis of Prostate Cancer within previous 6 months

• Age 75 years or younger

Exclusion Criteria:

PSA > 50 ng/ml Bone scan consistent with metastatic disease Other evidence that cancer of the prostate is not clinically localized Diagnosis of prostate cancer greater than 12 months ago Life expectancy less than 10 years Serum creatinine greater than 3 mg/dl Myocardial infarction within last 6 months Unstable angina New York Heart Association Class III or IV congestive heart failure Severe pulmonary disease Lifer failure Severe dementia Debilitating illness Malignancies, except for nonmelanomatous skin cancer, in the last 5 years

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• Radical prostatectomy
Surgical removal of the prostate

Locations

Country	Name	City	State
United States	VA Stratton Medical Center, Albany	Albany	New York
United States	VA Ann Arbor Healthcare System	Ann Arbor	Michigan
United States	VA Medical Center, Birmingham	Birmingham	Alabama
United States	VA Medical Center, Boise	Boise	Idaho
United States	VA Medical Center, Bronx	Bronx	New York
United States	New York Harbor Health Care System, Brooklyn	Brooklyn	New York
United States	VA Western New York Healthcare System at Buffalo	Buffalo	New York
United States	Jesse Brown VAMC (WestSide Division)	Chicago	Illinois
United States	VA Medical Center, Clarksburg	Clarksburg	West Virginia
United States	VA North Texas Health Care System, Dallas	Dallas	Texas
United States	VA New Jersey Health Care System, East Orange	East Orange	New Jersey
United States	VA Medical Center, Hampton	Hampton	Virginia
United States	Richard Roudebush VA Medical Center, Indianapolis	Indianapolis	Indiana
United States	VA Medical Center, Iowa City	Iowa City	Iowa
United States	VA Medical Center, Lexington	Lexington	Kentucky
United States	VA Medical Center, Long Beach	Long Beach	California
United States	Wlliam S. Middleton Memorial Veterans Hospital, Madison	Madison	Wisconsin
United States	VA Medical Center, Memphis	Memphis	Tennessee
United States	Minneapolis VA Health Care System	Minneapolis	Minnesota
United States	Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock	North Little Rock	Arkansas
United States	VA Medical Center, Oklahoma City	Oklahoma City	Oklahoma
United States	VA Pittsburgh Health Care System	Pittsburgh	Pennsylvania
United States	VA Medical Center, Portland	Portland	Oregon
United States	VA Medical Center, Providence	Providence	Rhode Island
United States	VA Medical Center, San Francisco	San Francisco	California
United States	VA Puget Sound Health Care System, Seattle	Seattle	Washington
United States	VA Greater Los Angeles HCS, Sepulveda	Sepulveda	California
United States	Overton Brooks VA Medical Center, Shreveport	Shreveport	Louisiana
United States	VA Medical Center, Syracuse	Syracuse	New York
United States	James A. Haley Veterans Hospital, Tampa	Tampa	Florida
United States	Central Texas Veterans Health Care System	Temple	Texas

Sponsors (3)

Lead Sponsor	Collaborator
VA Office of Research and Development	Agency for Healthcare Research and Quality (AHRQ), National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (18)

Barry MJ, Andriole GL, Culkin DJ, Fox SH, Jones KM, Carlyle MH, Wilt TJ. Ascertaining cause of death among men in the prostate cancer intervention versus observation trial. Clin Trials. 2013;10(6):907-14. doi: 10.1177/1740774513498008. Epub 2013 Aug 29. — View Citation

Kaplan SA, McConnell JD, Roehrborn CG, Meehan AG, Lee MW, Noble WR, Kusek JW, Nyberg LM Jr; Medical Therapy of Prostatic Symptoms (MTOPS) Research Group. Combination therapy with doxazosin and finasteride for benign prostatic hyperplasia in patients with — View Citation

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 — View Citation

Wilt T, Brawer M. The Prostate Cancer Intervention versus Observation Trial. Cancer. 1995 May 12; 75:1963-1968.

Wilt T. Editorial comment. Urology. 2001 Nov 1; 58(6):964-965.

Wilt T. Expectant management or early intervention for clinically localized prostate cancer? What we need are randomized trials. Clinical Care For Prostatic Diseases. 1994 Jan 6; 1:1-9.

Wilt T. The importance of randomized treatment trials in early stage prostate cancer. New Developments in Prostate Cancer and Treatment. 1997 Feb 21; 2:29-35.

Wilt TJ, Brawer MK, Jones KM, Barry MJ, Aronson WJ, Fox S, Gingrich JR, Wei JT, Gilhooly P, Grob BM, Nsouli I, Iyer P, Cartagena R, Snider G, Roehrborn C, Sharifi R, Blank W, Pandya P, Andriole GL, Culkin D, Wheeler T; Prostate Cancer Intervention versus — View Citation

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 clinic — View Citation

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

Wilt TJ, Scardino PT, Carlsson SV, Basch E. Prostate-specific antigen screening in prostate cancer: perspectives on the evidence. J Natl Cancer Inst. 2014 Mar;106(3):dju010. doi: 10.1093/jnci/dju010. Epub 2014 Mar 4. — View Citation

Wilt TJ. Clarifying uncertainty regarding detection and treatment of early-stage prostate cancer. Semin Urol Oncol. 2002 Feb;20(1):10-7. Review. — View Citation

Wilt TJ. Implications of the prostate intervention versus observation trial (PIVOT). Asian J Androl. 2012 Nov;14(6):815. doi: 10.1038/aja.2012.103. Epub 2012 Sep 17. — View Citation

Wilt TJ. Prostate cancer screening: practice what the evidence preaches. Am J Med. 1998 Jun;104(6):602-4. — View Citation

Wilt TJ. Prostate carcinoma practice patterns: what do they tell us about the diagnosis, treatment, and outcomes of patients with prostate carcinoma? Cancer. 2000 Mar 15;88(6):1277-81. — View Citation

Wilt TJ. SPCG-4: a needed START to PIVOTal data to promote and protect evidence-based prostate cancer care. J Natl Cancer Inst. 2008 Aug 20;100(16):1123-5. doi: 10.1093/jnci/djn259. Epub 2008 Aug 11. — View Citation

Wilt TJ. 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 with watchful waiting for men with clini — View Citation

Wilt TJ. Uncertainty in prostate cancer care: the physician's role in clearing the confusion. JAMA. 2000 Jun 28;283(24):3258-60. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All Cause Mortality	Number of deaths from any cause.	From date of randomization until date of death from any cause, assessed until end of study, up to 16 years