Trial Information

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

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.