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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00769223
Enrollment
3561
Registered
2008-10-09
Start date
1993-02-25
Completion date
2042-01-31
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer, Radiation Toxicity

Keywords

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

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.

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.

Interventions

OTHERmedical chart review
OTHERquestionnaire administration
PROCEDUREquality-of-life assessment
RADIATIONbrachytherapy
RADIATIONradiation therapy

Sponsors

University of California, San Francisco
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
MALE
Age
18 Years to 120 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Value of the pre-operative Gleason score, prostate-specific antigen level, and clinical stage in predicting the risk of failure and deathUp to 30 years or until deathThe 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

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORMack Roach, MD

University of California, San Francisco

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 15, 2026