NCT01368055Completed
Hypofractionated Proton Radiation Therapy for Low and Intermediate Risk Prostate Cancer
An Expanded Phase II Study of Hypofractionated Dose Intense Image Guided Proton Radiation Therapy for Low and Intermediate Risk Adenocarcinoma of the Prostate
Source: ClinicalTrials.gov · Last updated 29 Aug 2025
Brief summary (registry, in English)
The purpose of this trial is to give a shorter course (5 ½-6 weeks) of proton radiation that has as little side effects on normal bladder and rectal tissues as the usual longer course (8 weeks) of proton radiation, without decreasing the chance of killing prostate cancer cells.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 361 (actual)
- First submitted
- 1 Jun 2011
- Start date
- Sept 2011
- Primary completion date
- Aug 2025
- Lead sponsor
- University of Florida
- Diseases
- Prostate cancer
- NCT number
- NCT01368055
What you commit to
- Study type: Interventional
- Participants enrolled: 361
- From Sept 2011 to the primary completion date, Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous prostate cancer surgery or pelvic radiation.
- Prior/concurrent systemic chemotherapy for prostate cancer.
- Prior intrapelvic surgery.
- Taking Saw Palmetto or methotrexate and unable or unwilling to discontinue its uses during radiation.
Other illness
- Active inflammatory bowel disease (Crohn's disease, diverticulitis or ulcerative colitis) affecting the rectum.
- History of hip replacement.
Lab values
- Receiving continuous and current anticoagulation with Warfarin sodium (Coumadin), Clopidogrel bisulfate (Plavix), dabigatran etexilate mesylate (Pradaxa),enoxaparin sodium (Lovenox), or aspirin/er dipyridamole (Aggrenox).
Who the study is looking for
- Prostate cancer.
- Gleason score 2-6 or 7.
- PSA ≤ 20 ng/ml.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Florida Proton Therapy Institute Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.