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

Alliance for Clinical Trials in Oncology

Status: Completed

Conditions: Prostate Cancer

Treatments: Procedure: quality-of-life assessment

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00052481

CDR0000258478 (Registry Identifier)

ACOSOG-Z0071

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 500 patients

Sex: Male

Ages: Under 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

PRIOR CONCURRENT THERAPY:

Endocrine therapy

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

Trial design

500 participants in 1 patient group

Quality of life questionnaire

Description:

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 as part of ACOSOG-Z0071.

Treatment:

Procedure: quality-of-life assessment