Predicting the Risk of Failure in Patients Undergoing Radiation Therapy for Localized Prostate Cancer

Sponsor

University of California, San Francisco (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT00769223

Collaborator

(none)

3,561

Enrollment

Location

383.2

Anticipated Duration (Months)

9.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RATIONALE: Gathering information about the Gleason score, prostate-specific antigen (PSA) level, and cancer stage from patients who have undergone radiation therapy for prostate cancer may help doctors predict how patients respond to treatment and help plan the best treatment.

PURPOSE: This clinical trial is studying the Gleason score, PSA level, and cancer stage in predicting outcome in patients who have undergone radiation therapy for localized prostate cancer.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer Radiation Toxicity	Other: medical chart review Other: questionnaire administration Procedure: quality-of-life assessment Radiation: brachytherapy Radiation: radiation therapy

Detailed Description

OBJECTIVES:

Evaluate the value of the pre-operative Gleason score, prostate-specific antigen level, and clinical stage in predicting the risk of failure and death in patients who have undergone radiotherapy for localized prostate cancer.

OUTLINE: This is a multicenter study.

Patient medical records are reviewed to collect data about pre-treatment prostate biopsy, assigned Gleason score, prostate-specific antigen level, and radionucleotide bone scan.

Patients complete a Bowel Toxicity questionnaire to assess quality of life related to acute and long-term bowel toxicity after radiotherapy.

Study Design

Study Type:

Observational

Actual Enrollment :

3561 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

Pre-Operative Gleason Score and PSA and Clinical Stage in Predicting the Risk of Failure in Patients Undergoing Radiation Therapy for Localized Prostate Cancer

Actual Study Start Date :

Feb 25, 1993

Anticipated Primary Completion Date :

Jan 31, 2025

Anticipated Study Completion Date :

Jan 31, 2025

Outcome Measures

Primary Outcome Measures

Value of the pre-operative Gleason score, prostate-specific antigen level, and clinical stage in predicting the risk of failure and death [Up to 30 years or until death]
The investigator will be analyzing the effect of baseline patient and clinical features such as age, Gleason score, PSA, clinical stage and percent positive biopsies on survival as well as quality of life parameters including potency, continence, and American Urological Association (AUA) symptoms scores

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Diagnosis of localized adenocarcinoma of the prostate
Has undergone radiotherapy (external beam radiotherapy and/or brachytherapy) with or without hormonal therapy for adenocarcinoma of the prostate in the University of California, San Francisco (UCSF) Radiation Oncology Department at San Francisco General Hospital or Veterans Administration Medical Center of San Francisco between 1987 and 2006