Quality of Life in Patients Undergoing Surgery or Brachytherapy for Stage II Prostate Cancer - Full Text View

Purpose

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.

Condition	Intervention
Cancer-Related Problem/Condition Prostate Cancer	Procedure: quality-of-life assessment

MedlinePlus related topics:

Cancer Prostate Cancer

U.S. FDA Resources

Study Type:	Observational

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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:	September 2002
Primary Completion Date:	April 2004 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	up to 75 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00052481

Locations


United States, California
	UCSF Comprehensive Cancer Center
	San Francisco, California, United States, 94143-0128

United States, District of Columbia
	Walter Reed Army Medical Center
	Washington, District of Columbia, United States, 20307-5000

United States, Iowa
	Holden Comprehensive Cancer Center at University of Iowa
	Iowa City, Iowa, United States, 52242-1062

United States, Massachusetts
	Beth Israel Deaconess Medical Center
	Boston, Massachusetts, United States, 02215

United States, Missouri
	Washington University School of Medicine
	Saint Louis, Missouri, United States, 63110

United States, New York
	James P. Wilmot Cancer Center at University of Rochester Medical Center
	Rochester, New York, United States, 14642
	Memorial Sloan-Kettering Cancer Center
	New York, New York, United States, 10021

United States, North Carolina
	Presbyterian Hospital
	Charlotte, North Carolina, United States, 28233-3549

United States, Ohio
	Cleveland Clinic Taussig Cancer Center
	Cleveland, Ohio, United States, 44195

United States, Vermont
	Fletcher Allen Health Care - Medical Center Campus
	Burlington, Vermont, United States, 05401

United States, Virginia
	Sentara Norfolk General Hospital
	Norfolk, Virginia, United States, 23507

United States, Washington
	Madigan Army Medical Center
	Tacoma, Washington, United States, 98431-5048
	University Cancer Center at University of Washington Medical Center
	Seattle, Washington, United States, 98195-6043

Sponsors and Collaborators

American College of Surgeons

National Cancer Institute (NCI)

Investigators


Study Chair:	Martin G. Sanda, MD	Beth Israel Deaconess Medical Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000258478, ACOSOG-Z0071
First Received:	January 24, 2003
Last Updated:	October 18, 2008
ClinicalTrials.gov Identifier:	NCT00052481
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

quality of life

stage II prostate cancer

adenocarcinoma of the prostate

Study placed in the following topic categories:

Prostatic Diseases

Genital Neoplasms, Male

Quality of Life

Urogenital Neoplasms

Genital Diseases, Male

Adenocarcinoma

Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

ClinicalTrials.gov processed this record on November 20, 2008

Sponsors and Collaborators:	American College of Surgeons National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00052481