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

This study has been completed.
Sponsor:
Collaborator:
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
  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
Prostate Cancer
Procedure: quality-of-life assessment

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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
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
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States, 98195-6043
Madigan Army Medical Center
Tacoma, Washington, United States, 98431-5048
Sponsors and Collaborators
American College of Surgeons
Investigators
Study Chair: Martin G. Sanda, MD Beth Israel Deaconess Medical Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00052481     History of Changes
Other Study ID Numbers: CDR0000258478, ACOSOG-Z0071
Study First Received: January 24, 2003
Last Updated: February 18, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IIB prostate cancer
stage IIA prostate cancer
adenocarcinoma of the prostate

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 21, 2014