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

This study has been completed.

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by:

National Cancer Institute (NCI)

ClinicalTrials.gov Identifier:

NCT00052481

First received: January 24, 2003

Last updated: February 18, 2011

Last verified: February 2004

History of Changes

Tracking Information

First Received Date ^ICMJE

January 24, 2003

Last Updated Date

February 18, 2011

Start Date ^ICMJE

September 2002

Primary Completion Date

April 2004 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00052481 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Not Provided

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Not Provided

Study Population

Not Provided

Condition ^ICMJE

Prostate Cancer

Intervention ^ICMJE

Procedure: quality-of-life assessment

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Not Provided

Completion Date

Not Provided

Primary Completion Date

April 2004 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Performance status

Not specified

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Not specified

Renal

Not specified

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

Gender

Male

Ages

up to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00052481

Other Study ID Numbers ^ICMJE

CDR0000258478, ACOSOG-Z0071

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

American College of Surgeons

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Martin G. Sanda, MD

Beth Israel Deaconess Medical Center

Information Provided By

National Cancer Institute (NCI)

Verification Date

February 2004

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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