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

2014-08-27 03:59:06 | BioPortfolio


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.



- 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.

Study Design

Allocation: Randomized, Control: Active Control, Primary Purpose: Treatment


Prostate Cancer


chemotherapy, endocrine-modulating drug therapy, conventional surgery, radiation therapy


Iowa Lutheran Hospital
Des Moines
United States


Active, not recruiting


National Cancer Institute (NCI)

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:59:06-0400

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