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Randomized Study of Health-Related Quality of Life in Patients With Stage II Prostate Cancer Treated With Radical Prostatectomy or Brachytherapy

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
No phase specified Natural history/Epidemiology Completed 75 and under NCI ACOSOG-Z0071
ACOSOG-Z0071, NCT00052481

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.

Entry 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

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

Patient Characteristics:

Age

75 and under

Performance status

Not specified

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Not specified

Renal

Not specified

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

American College of Surgeons Oncology Group

Martin Sanda, MD, Protocol chair
Ph: 617-667-2960

Related Information

PDQ® clinical trial ACOSOG-Z0070

Registry Information

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

Trial Start Date		2002-09-24

Trial Completion Date		2004-04-09

Registered in ClinicalTrials.gov		NCT00052481

Date Submitted to PDQ		2002-10-03

Information Last Verified		2004-02-18

NCI Grant/Contract Number		CA76001

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.