Proton Radiation Therapy for Prostate Cancer
(PR11 Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does exclude people who are currently taking certain blood thinners like warfarin, heparin, and others. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the treatment HR-A, HR-B in the clinical trial for Proton Radiation Therapy for Prostate Cancer?
Is proton radiation therapy safe for prostate cancer patients?
How does proton radiation therapy differ from other treatments for prostate cancer?
Proton radiation therapy is unique because it uses a proton beam that can deliver high doses of radiation directly to the prostate tumor with minimal impact on surrounding healthy tissues, thanks to a property called the Bragg peak. This allows for potentially higher doses of radiation compared to traditional X-ray therapies, which may lead to fewer side effects.26111213
What is the purpose of this trial?
The purpose of this research study is to determine if dose-escalated proton radiation therapy is a good way to treat high-risk prostate cancer. The study features hypofractionation and a simultaneous integrated boost to the magnetic resonance imaging (MRI) identified intraprostatic tumor (IPT) as a method of dose-escalating radiation therapy. The study will include patients with high-risk prostate cancer who are at the highest risk for recurrence. Radiation therapy will be delivered over the course of 8-9 weeks. Additionally, androgen deprivation therapy (ADT) will be started 8-10 weeks prior to starting radiation and continued for a total of 18 months if the patient decides to receive ADT.
Research Team
Curtis M Bryant, MD, MPH
Principal Investigator
University of Florida Health Proton Therapy Institute
Eligibility Criteria
Men over 18 with high-risk prostate cancer, who haven't had previous local treatments or pelvic radiation. They must have a visible tumor on MRI, no distant metastasis or positive lymph nodes, and be able to start treatment within 16 weeks of signing up. Participants should not have severe heart failure, end stage renal disease, inflammatory bowel diseases affecting the rectum, or recent major intrapelvic surgery.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Androgen Deprivation Therapy (ADT)
ADT is started 8-10 weeks prior to radiation and continued for a total of 18 months
Radiation Therapy
Dose-escalated proton radiation therapy delivered over 8-9 weeks with a simultaneous integrated boost to the MRI identified intraprostatic tumor
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of biochemical failure, local recurrence, and overall survival
Treatment Details
Interventions
- HR-A
- HR-B
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Florida
Lead Sponsor