Expired Study
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Long Beach, California 90822


Purpose:

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.


Study summary:

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.


Criteria:

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


Study is Available At:


Original ID:

407


NCT ID:

NCT00007644


Secondary ID:


Study Acronym:

PIVOT


Brief Title:

Prostate Cancer Intervention Versus Observation Trial (PIVOT):A Randomized Trial Comparing Radical Prostatectomy Versus Palliative Expectant Managemen


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


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Male


Minimum Age:

N/A


Maximum Age:

75 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Department of Veterans Affairs


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

731


Enrollment Type:

Actual


Overall Contact Information

Official Name:Timothy J. Wilt, MD MPH
Study Chair
Minneapolis Veterans Affairs Medical Center

Study Dates

Start Date:June 1994
Completion Date:January 2010
Completion Type:Actual
Primary Completion Date:January 2010
Primary Completion Type:Actual
Verification Date:August 2013
Last Changed Date:August 9, 2013
First Received Date:December 29, 2000

Study Outcomes

Outcome Type:Primary Outcome
Measure:All Cause Mortality
Time Frame:Annual
Safety Issues:False

Study Interventions

Intervention Type:Procedure
Name:Radical prostatectomy
Description:Surgical removal of the prostate
Arm Name:Arm 1
Intervention Type:Procedure
Name:Expectant management with palliative therapy
Description:palliative therapy for symptomatic or metastatic disease progression
Arm Name:Arm 2

Study Arms

Study Arm Type:Other
Arm Name:Arm 1
Description:Radical Prostatectomy
Study Arm Type:Other
Arm Name:Arm 2
Description:Watchful Waiting

Study Agencies

Agency Class:U.S. Fed
Agency Type:Lead Sponsor
Agency Name:Department of Veterans Affairs
Agency Class:U.S. Fed
Agency Type:Collaborator
Agency Name:Agency for Healthcare Research and Quality (AHRQ)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
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 Natl Cancer Inst Monogr. 1995;(19):69-71. No abstract available.
PMID:7577210
Reference Type:Results Reference
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 clinically localized prostate cancer. Semin Urol. 1995 May;13(2):130-6. No abstract available.
PMID:7638470
Reference Type:Results Reference
Citation: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.
PMID:9268976
Reference Type:Results Reference
Citation:Wilt TJ. Prostate cancer screening: practice what the evidence preaches. Am J Med. 1998 Jun;104(6):602-4. No abstract available.
PMID:9674725
Reference Type:Results Reference
Citation:Wilt TJ. Uncertainty in prostate cancer care: the physician's role in clearing the confusion. JAMA. 2000 Jun 28;283(24):3258-60. No abstract available.
PMID:10866876
Reference Type:Results Reference
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. No abstract available.
PMID:10717606
Reference Type:Results Reference
Citation:Wilt TJ. Clarifying uncertainty regarding detection and treatment of early-stage prostate cancer. Semin Urol Oncol. 2002 Feb;20(1):10-7. Review.
PMID:11828353
Reference Type:Results Reference
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. Epub 2008 Aug 11. No abstract available.
PMID:18695131
Reference Type:Results Reference
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 lower urinary tract symptoms and a baseline total prostate volume of 25 ml or greater. J Urol. 2006 Jan;175(1):217-20; discussion 220-1.
PMID:16406915
Reference Type:Results Reference
Citation: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 Observation Trial (PIVOT) Study Group. Radical prostatectomy versus observation for localized prostate cancer. N Engl J Med. 2012 Jul 19;367(3):203-13.
PMID:22808955

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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