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

NCT ID: NCT00769223

Last Updated: 2025-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

3561 participants

Study Classification

OBSERVATIONAL

Study Start Date

1993-02-25

Study Completion Date

2026-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Prostate Cancer Radiation Toxicity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Interventions

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medical chart review

Intervention Type OTHER

questionnaire administration

Intervention Type OTHER

quality-of-life assessment

Intervention Type PROCEDURE

brachytherapy

Intervention Type RADIATION

radiation therapy

Intervention Type RADIATION

Eligibility Criteria

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Inclusion 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 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

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mack Roach, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California, San Francisco

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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H7056-08989

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2019-08819

Identifier Type: REGISTRY

Identifier Source: secondary_id

01558

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000597000

Identifier Type: -

Identifier Source: org_study_id

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