Stereotactic Body Radiation Therapy in Treating Patients With Low- and Intermediate-Risk Prostate Cancer
Stopped early · Not applicable
Conditions studied: Prostate Adenocarcinoma, Stage I Prostate Cancer
In brief
This clinical trial studies stereotactic body radiation therapy in treating patients with low- and intermediate-risk prostate cancer. Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.
Key facts
- Study ID
- NCT01737151
- Run by
- Virginia Commonwealth University
- People needed
- 19
- Starts
- 2013-03-08
- Expected to finish
- 2017-11-09
- Last updated by the study team
- 2019-09-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients must have low or intermediate risk adenocarcinoma of the prostate as defined by:
- Low-risk disease - Histopathology score (Gleason sum): =<6, T-stage (per current AJCC staging criteria): T1c-T2a, and PSA: <10
- Intermediate-risk disease as either:
- Histopathology score (Gleason sum) =< 6, T-stage (per current American Joint Committee on Cancer [AJCC] staging criteria): T1c-T2a, and prostate-specific antigen (PSA) > 10 but =< 20; or
- Histopathology score (Gleason sum) 7 with =< 50% of any cores positive, T-stage (per current AJCC staging criteria): T1c-T2a, and PSA < 10
- Charlson index of comorbidity score =< 4
- Ability to understand and the willingness to sign a written informed consent document
You may not qualify if…
- Patients with history of inflammatory bowel disease, or who require steroid or cytotoxic therapy for collagen vascular disease
- Patients with a history of cancer other than skin cancer within 5 years of the initiation of protocol treatment
- Patients with a history of pelvic irradiation for any reason
- Life expectancy < 10 years - Prior treatment with an anti-androgen, luteinizing hormone-releasing hormone (LHRH) agonist, or a combination of the two
- Prior radiation therapy, brachytherapy, or cryotherapy
- Prior surgical procedure involving peri-rectal and peri-prostatic area
Where it is running
- University of Virginia Medical Center — Charlottesville, Virginia, United States
- Hunter Holmes McGuire VA Medical Center — Richmond, Virginia, United States
- Virginia Commonwealth University/Massey Cancer Center — Richmond, Virginia, United States
Full record on ClinicalTrials.gov
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