Surgery in Treating Patients With Prostate Cancer - Full Text View

Sponsor:	Cancer and Leukemia Group B
Collaborators:	National Cancer Institute (NCI) Southwest Oncology Group
Information provided by:	Cancer and Leukemia Group B
ClinicalTrials.gov Identifier:	NCT00002938

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 II

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Further study details as provided by Cancer and Leukemia Group B:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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:	June 2008 (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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002938

Show 61 Study Locations

Sponsors and Collaborators

Cancer and Leukemia Group B

National Cancer Institute (NCI)

Southwest Oncology Group

Investigators

Study Chair:	Gary D. Steinberg, MD	University of Chicago
Study Chair:	Joseph W. Basler, MD, PhD	University of Texas

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

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.

Responsible Party:	Monica M Bertagnolli, MD, 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 8, 2011
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 February 12, 2012