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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


Phase 3
N/A
75 Years
Open (Enrolling)
Male
Prostate Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Timothy James Wilt, MD, MPH

Investigator Role:

Study Chair

Investigator Affiliation:

Veterans Affairs Medical Center - Minneapolis

Authority:

United States: Federal Government

Study ID:

CDR0000063882

NCT ID:

NCT00002606

Start Date:

Completion Date:

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage I prostate cancer
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • Prostatic Neoplasms

Name

Location

Penn State Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
MBCCOP - University of New Mexico HSCAlbuquerque, New Mexico  87131
CCOP - St. Vincent Hospital Cancer Center, Green BayGreen Bay, Wisconsin  54301
Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa  50309
Mercy Cancer Center at Mercy Medical Center-Des MoinesDes Moines, Iowa  50314
Midlands Cancer Center at Midlands Community HospitalPapillion, Nebraska  68128-4157