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.