Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Surgery in Treating Patients With Prostate Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	75 and under	NCI	CALGB-9687 SWOG-C9687, NCT00002938

Objectives

1. 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.
2. 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.
3. Determine the quality of life measures in these patients.
4. 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.
5. Determine the histologic and morphometric characterization of the carcinoma.

Entry Criteria

Disease Characteristics:

• Histologically proven recurrent or persistent prostate cancer



• Prostate-specific antigen (PSA) no greater than 20 ng/mL



• Must have been previously treated with at least 60 cGy of external beam radiotherapy or brachytherapy for clinical stages T1-2NXM0 with PSA no greater than 30 ng/mL



• No metastatic disease at time of biopsy

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• Not specified

Endocrine therapy:

• At least 3 months since prior adjuvant hormonal therapy

Radiotherapy:

• See Disease Characteristics
• At least 18 months since prior external beam or interstitial radiotherapy

Surgery:

• Not specified

Patient Characteristics:

Age:

• 75 and under

Performance status:

• CALGB (Zubrod) 0-1

Life expectancy:

• At least 5-10 years

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

Other:

• No other "currently Temporarily closed" malignancy except nonmelanoma skin cancer
  • Patients are not considered to have a "currently Temporarily closed" malignancy if they have completed therapy and are considered to be at less than 30% risk of relapse

Expected Enrollment

A total of 40 patients will be accrued for this study within 2 years.

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.

Sokoloff MH, Halabi S, Sanford B, et al.: Management of recurrent prostate cancer after radiotherapy: preliminary results of CALGB 9687, a contemporary salvage prostatectomy series. [Abstract] American Society of Clinical Oncology 2005 Prostate Cancer Symposium, 17-19 February 2005, Orlando, Florida. A-166, 2005.

Trial Contact Information

Trial Lead Organizations

Cancer and Leukemia Group B

Gary Steinberg, MD, Protocol chair		Ph: 773-702-3080; 888-824-0200 Email: gsteinbe@surgery.bsd.uchicago.edu

Southwest Oncology Group

Joseph Basler, MD, PhD, Protocol chair		Ph: 210-567-5643 Email: basler@uthscsa.edu

Registry Information
Official Title		The Role of Salvage Prostatectomy for Radiation Failure in Prostate Carcinoma: A Phase II Trial
Registered in ClinicalTrials.gov		NCT00002938
Date Submitted to PDQ		1997-05-31
Information Last Verified		2006-03-16
NCI Grant/Contract Number		CA31946

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