RATIONALE: Quality of life assessment in patients undergoing prostate cancer treatment may help determine the intermediate-term and long-term effects of surgery and brachytherapy.

PURPOSE: Randomized clinical trial to study quality of life in patients undergoing radical prostatectomy or brachytherapy for stage II prostate cancer.

Condition	Treatment or Intervention
Quality of Life stage II prostate cancer adenocarcinoma of the prostate	Procedure: quality-of-life assessment  Procedure: supportive care/therapy

Further Study Details: 

OBJECTIVES:

• Compare changes in health-related quality of life (HRQOL) in patients with stage II prostate cancer up to 2 years after treatment with radical prostatectomy or brachytherapy.
• Compare the effect of baseline HRQOL, age, and other covariates on HRQOL improvement or deterioration in these patients up to 10 years after these treatments.
• Compare the effect of treatment modality on HRQOL improvement or deterioration in these patients up to 10 years after these treatments.
• Compare the effects of treatment failure on HRQOL, in terms of disease progression, in these patients.

OUTLINE: Patients are randomized to 1 of 2 arms on ACOSOG-Z0070 (radical prostatectomy vs brachytherapy).

Patients in both arms complete a quality of life questionnaire at baseline, 2 and 6 months after treatment, and then at 1, 2, 4, 7, and 10 years after treatment.

PROJECTED ACCRUAL: A total of 500 patients (250 per group) will be accrued for this study within 2 years.

Ages Eligible for Study:  up to  75 Years,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the prostate within the past 120 days
• Stage II disease (T1c-T2a, N0, M0)
• Concurrent enrollment on ACOSOG-Z0070
• Not yet randomized to an intervention arm (radical prostatectomy or brachytherapy)
• Willing and able to complete heath-related quality of life questionnaires

PATIENT CHARACTERISTICS: Age

• 75 and under

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

PRIOR CONCURRENT THERAPY: Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• More than 6 months since prior hormonal therapy for prostate cancer

Radiotherapy

• See Disease Characteristics

Surgery

• See Disease Characteristics

California
      UCSF Comprehensive Cancer Center, San Francisco,  California,  94143-0128,  United States
District of Columbia
      Walter Reed Army Medical Center, Washington,  District of Columbia,  20307-5000,  United States
Iowa
      Holden Comprehensive Cancer Center at University of Iowa, Iowa City,  Iowa,  52242-1062,  United States
Massachusetts
      Beth Israel Deaconess Medical Center, Boston,  Massachusetts,  02215,  United States
Missouri
      Washington University School of Medicine, Saint Louis,  Missouri,  63110,  United States
New York
      James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester,  New York,  14642,  United States
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States
North Carolina
      Presbyterian Hospital, Charlotte,  North Carolina,  28233-3549,  United States
Ohio
      Cleveland Clinic Taussig Cancer Center, Cleveland,  Ohio,  44195,  United States
Vermont
      Fletcher Allen Health Care - Medical Center Campus, Burlington,  Vermont,  05401,  United States
Virginia
      Sentara Norfolk General Hospital, Norfolk,  Virginia,  23507,  United States
Washington
      Madigan Army Medical Center, Tacoma,  Washington,  98431-5048,  United States
      University Cancer Center at University of Washington Medical Center, Seattle,  Washington,  98195-6043,  United States

Study chairs or principal investigators

Martin G. Sanda, MD,  Study Chair,  Beth Israel Deaconess Medical Center   

Study ID Numbers:  CDR0000258478; ACOSOG-Z0071
Record last reviewed:  June 2004
Last Updated:  October 13, 2004
Record first received:  January 24, 2003
ClinicalTrials.gov Identifier:  NCT00052481
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08