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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00769223
- Acronym / sponsor ID
- CDR0000597000
- 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
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,561 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 25 Feb 1993 (actual)
- Primary completion
- 31 Jan 2042 (estimated)
- Study completion
- 31 Jan 2042 (estimated)
- First posted
- 9 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Prostate Cancer patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| medical chart review | Other | – |
| questionnaire administration | Other | – |
| quality-of-life assessment | Procedure or surgery | – |
| brachytherapy | Radiation | – |
| radiation therapy | Radiation | – |
Primary outcome
Value of the pre-operative Gleason score, prostate-specific antigen level, and clinical stage in predicting the risk of failure and death
Time frame: Up to 30 years or until 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mack Roach, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Radiation Toxicity, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Value of the pre-operative Gleason score, prostate-specific antigen level, and clinical stage in predicting the risk of failure and death (time frame: Up to 30 years or until death). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.