Prostate CancerNCT00769223
Predicting the Risk of Failure in Patients Undergoing Radiation Therapy for Localized Prostate Cancer
An observational study of Prostate Cancer and Radiation Toxicity, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years, men only
- Conditions the study is for
- Prostate Cancer, Radiation Toxicity
- What is being tested?
- medical chart review, questionnaire administration and quality-of-life assessment
- Type of treatment
- Surgery or procedure
- How many people
- 3,561 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 1993to 31 Jan 2042
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Prostate Cancer patients
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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
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
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.
Read the 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.
- Conditions
- Prostate Cancer, Radiation Toxicity
- Being tested
- medical chart review, questionnaire administration, quality-of-life assessment, brachytherapy, radiation therapy
- 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
- Medical subject headings
- Prostatic Neoplasms, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medical chart reviewOther
questionnaire administrationOther
quality-of-life assessmentProcedure or surgery
brachytherapyRadiation
radiation therapyRadiation
What is being measured
The primary outcome is the main question the study is designed to answer.
Value of the pre-operative Gleason score, prostate-specific antigen level, and clinical stage in predicting the risk of failure and 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
Measured: Up to 30 years or until death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2008 (estimated)
- Study start25 Feb 1993
- Primary completion31 Jan 2042 (estimated)
- Study completion31 Jan 2042 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 3,561 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mack Roach, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00769223
- Sponsor's protocol ID
- CDR0000597000
- Other IDs
- H7056-08989, NCI-2019-08819, 01558
- Status last verified
- Sep 2026
- First submitted
- 8 Oct 2008
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No