Quality of Life in Patients Undergoing Surgery or Brachytherapy for Stage II Prostate Cancer

Alliance for Clinical Trials in Oncology500 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

Prostate Cancer

Interventions

quality-of-life assessmentPROCEDURE

Eligibility

Sex: MALEMax age: 75 Years

Medical Language ↔ Plain English

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 PRIOR CONCURRENT THERAPY: Endocrine therapy * More than 6 months since prior hormonal therapy for prostate cancer

Locations (13)

UCSF Comprehensive Cancer Center

San Francisco, California, United States

Walter Reed Army Medical Center

Washington D.C., District of Columbia, United States

Outcomes

Primary Outcomes

time to treatment failure

Time frame: Up to 10 years

Secondary Outcomes

disease progression

Time frame: Up to 10 years

Data from ClinicalTrials.gov

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