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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00052481
First Posted: January 27, 2003
Last Update Posted: July 6, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
  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
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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 Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • time to treatment failure [ Time Frame: Up to 10 years ]

Secondary Outcome Measures:
  • disease progression [ Time Frame: Up to 10 years ]

Enrollment: 500
Study Start Date: September 2002
Study Completion Date: April 2004
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Quality of life questionnaire

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 as part of ACOSOG-Z0071.

Procedure: quality-of-life assessment

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   up to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with adenocarcinoma of the prostate and previously enrolled on ACOSOG-Z0070.
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
Study Chair: Sandra G. Martin, MD Beth Israel Deaconess Medical Center
  More Information

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00052481     History of Changes
Other Study ID Numbers: ACOSOG-Z0071
CDR0000258478 ( Registry Identifier: NCI Physician Data Query )
First Submitted: January 24, 2003
First Posted: January 27, 2003
Last Update Posted: July 6, 2016
Last Verified: July 2016

Keywords provided by Alliance for Clinical Trials in Oncology:
stage IIB prostate cancer
stage IIA prostate cancer
adenocarcinoma of the prostate

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