NCT00002938

Surgery in Treating Patients With Prostate Cancer

The Role of Salvage Prostatectomy for Radiation Failure in Prostate Carcinoma: A Phase II Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: Male
• Age: 75 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Prostatectomy may be an effective treatment for prostate cancer that has not responded to radiation therapy. PURPOSE: This phase II trial is studying how well prostatectomy works in treating patients with recurrent or persistent prostate cancer that has not responded to radiation therapy.

Detailed description

OBJECTIVES: * Determine the characteristics of failure-free survival, disease-free survival, overall survival, surgical morbidity and mortality, and quality of life of patients treated with salvage prostatectomy for the recurrence of persistent disease after treatment with prior radiotherapy for localized prostate cancer. * Develop expertise in the use of salvage prostatectomy prior to a possible phase III trial of salvage prostatectomy in this population versus a control arm such as hormonal therapy or cryotherapy. * Determine the quality of life measures in these patients. * Determine the preliminary data on the quality of life of patients undergoing salvage radical prostatectomy and use the data to design a phase III study. * Determine the histologic and morphometric characterization of the carcinoma. OUTLINE: Patients undergo modified bilateral pelvic lymph node dissection. Patients with negative nodes undergo salvage prostatectomy via either retropubic or perineal approach. Patients with positive nodes may undergo radical prostatectomy at the discretion of the investigator. Postoperative hormonal therapy may be given at time of symptomatic disease progression or a newly positive bone scan, or for a consistently rising prostate-specific antigen. Adjuvant hormonal therapy is also allowed. Quality of life is assessed prior to surgery and at 3, 6, 12, 18, and 24 months after surgery. Patients are followed at least every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 2 years.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
PROCEDURE	conventional surgery	Salvage prostatectomy

Timeline

• Start date: 1997-05-01
• Primary completion: 2005-02-01
• Completion: 2010-01-01
• First posted: 2003-01-27
• Last updated: 2016-07-06

Locations

61 sites across 1 country: United States