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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00052481

Enrollment

500

Registered

2003-01-27

Start date

2002-09-30

Completion date

2004-04-30

Last updated

2016-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

stage IIB prostate cancer, stage IIA prostate cancer, adenocarcinoma of the prostate

Brief summary

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.

Detailed 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.

Interventions

PROCEDUREquality-of-life assessment

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

No minimum to 75 Years

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame
time to treatment failure	Up to 10 years

Secondary

Measure	Time frame
disease progression	Up to 10 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026