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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00052481
• Other study ID #: ACOSOG-Z0071
• Secondary ID: ACOSOG-Z0071CDR0
• Status: Completed
• Phase: N/A
• First received: January 24, 2003
• Last updated: July 1, 2016
• Start date: September 2002
• Est. completion date: April 2004

Study information

• Verified date: July 2016
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: April 2004
• Est. primary completion date: April 2004
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A to 75 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• quality-of-life assessment

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Fletcher Allen Health Care - Medical Center Campus	Burlington	Vermont
United States	Presbyterian Hospital	Charlotte	North Carolina
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	Holden Comprehensive Cancer Center at University of Iowa	Iowa City	Iowa
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	James P. Wilmot Cancer Center at University of Rochester Medical Center	Rochester	New York
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	UCSF Comprehensive Cancer Center	San Francisco	California
United States	University Cancer Center at University of Washington Medical Center	Seattle	Washington
United States	Madigan Army Medical Center	Tacoma	Washington
United States	Walter Reed Army Medical Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to treatment failure		Up to 10 years	No
Secondary	disease progression		Up to 10 years	No