Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Further Study Information

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.

Eligibility 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

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

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Cancer and Leukemia Group B

Gary D. Steinberg

Study Chair

Joseph W. Basler

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00002938
Information obtained from ClinicalTrials.gov on December 14, 2011

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