Gleason Score, Prostate-Specific Antigen Level, and Cancer Stage in Predicting Outcome in Patients Who Have Undergone Radiation Therapy for Localized Prostate Cancer

This study is currently recruiting participants.
Verified January 2014 by University of California, San Francisco
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00769223
First received: October 8, 2008
Last updated: January 23, 2014
Last verified: January 2014
  Purpose

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 Intervention
Prostate Cancer
Radiation Toxicity
Other: medical chart review
Other: questionnaire administration
Procedure: quality-of-life assessment
Radiation: brachytherapy
Radiation: radiation therapy

Study Type: Observational
Study Design: Observational Model: Cohort
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

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

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 [ Designated as safety issue: No ]

Estimated Enrollment: 3500
Study Start Date: February 1993
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Prostate Cancer patients

Criteria

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 UCSF Radiation Oncology Department at San Francisco General Hospital or Veterans Administration Medical Center of San Francisco between 1987 and 2006

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00769223

Locations
United States, California
UCSF Helen Diller Family Comprehensive Cancer Center Recruiting
San Francisco, California, United States, 94115
Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensi    877-827-3222      
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Mack Roach, MD University of California, San Francisco
  More Information

Additional Information:
No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00769223     History of Changes
Other Study ID Numbers: CDR0000597000, UCSF-H7056-08989
Study First Received: October 8, 2008
Last Updated: January 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
radiation toxicity
recurrent prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
stage I prostate cancer
stage IV prostate cancer
adenocarcinoma of the prostate

Additional relevant MeSH terms:
Prostatic Neoplasms
Radiation Injuries
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on April 17, 2014