Surgery in Treating Patients With Prostate Cancer
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Procedure: conventional surgery |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Role of Salvage Prostatectomy for Radiation Failure in Prostate Carcinoma: A Phase II Trial |
- Survival characteristics [ Time Frame: pre treatment; q 3 mon for 2 years, then q 6 mon for 2 yrs, then q year ] [ Designated as safety issue: No ]
- QOL assessment [ Time Frame: pre treatment; 3, 6, 12, 18, and 24 mon post treatment ] [ Designated as safety issue: No ]Quality of life questionnaire
| Enrollment: | 49 |
| Study Start Date: | May 1997 |
| Estimated Study Completion Date: | March 2016 |
| Primary Completion Date: | February 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Surgery
Salvage prostatectomy
|
Procedure: conventional surgery
Salvage prostatectomy
|
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.
Eligibility| Ages Eligible for Study: | up to 75 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Show 61 Study Locations| Study Chair: | Gary D. Steinberg, MD | University of Chicago |
| Study Chair: | Joseph W. Basler, MD, PhD | University of Texas Health Science Center at San Antonio |
More Information
Additional Information:
Publications:
| Responsible Party: | Cancer and Leukemia Group B |
| ClinicalTrials.gov Identifier: | NCT00002938 History of Changes |
| Other Study ID Numbers: | CDR0000065381, U10CA031946, CALGB-9687, SWOG-C9687 |
| Study First Received: | November 1, 1999 |
| Last Updated: | March 15, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Cancer and Leukemia Group B:
|
recurrent prostate cancer |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013