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 by National Cancer Institute (NCI), December 2008

First Received: October 8, 2008 Last Updated: May 9, 2009 History of Changes

Sponsor:	University of California, San Francisco
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00769223

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
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:

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

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:	February 2013 (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

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

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Mack Roach, MD

University of California, San Francisco

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	UCSF Helen Diller Family Comprehensive Cancer Center ( Mack Roach, III )
Study ID Numbers:	CDR0000597000, UCSF-H7056-08989
Study First Received:	October 8, 2008
Last Updated:	May 9, 2009
ClinicalTrials.gov Identifier:	NCT00769223 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

radiation toxicity
recurrent prostate cancer
stage II prostate cancer
stage III prostate cancer

stage I prostate cancer
stage IV prostate cancer
adenocarcinoma of the prostate

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on February 08, 2010