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



Status:Completed
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any - 75
Updated:4/21/2016
Start Date:September 2002
End Date:April 2004

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Health-Related Quality Of Life In Patients With Low Risk, Localized Prostate Cancer Randomized To Radical Prostatectomy Or Brachytherapy

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.

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
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