Short-course Proton Radiation for Prostate Cancer
(PR07 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a shorter course of proton radiation therapy for prostate cancer, aiming to reduce treatment time while minimizing side effects on the bladder and rectum. The researchers aim to maintain the effectiveness of longer treatments in killing cancer cells. Participants should have prostate cancer with a Gleason score of 2-7 and a PSA level of 20 or less, without prior prostate surgery or inflammatory bowel disease.
As an unphased trial, it offers patients the opportunity to contribute to innovative research that could improve future treatment options.
Will I have to stop taking my current medications?
If you are taking Saw Palmetto or methotrexate, you will need to stop using them during the radiation treatment. If you are on certain blood thinners like Warfarin, Plavix, Pradaxa, Lovenox, or Aggrenox, you cannot participate in the trial.
What prior data suggests that hypofractionated proton radiation therapy is safe for prostate cancer?
Research has shown that hypofractionated proton radiation therapy is generally safe for treating prostate cancer. One study found it safe and effective for patients with low-risk prostate cancer, using 60 Gy over 20 sessions. Another study reported fewer bladder and urinary side effects compared to traditional photon therapy. Additionally, a different study showed a high survival rate, with only one prostate cancer death over five years. This evidence suggests the treatment is well-tolerated with few serious side effects.12345
Why are researchers excited about this trial?
Researchers are excited about hypofractionated proton radiation therapy for prostate cancer because it offers a more precise and potentially faster treatment option. Unlike traditional radiation therapies, which can take several weeks, hypofractionated proton therapy delivers higher doses of radiation in fewer sessions, possibly reducing treatment time and improving patient convenience. This method uses proton beams, which can more accurately target tumors while sparing surrounding healthy tissue, potentially leading to fewer side effects. By tailoring the radiation dose to the risk level, this approach might provide a more customized treatment strategy for both low-risk and intermediate-risk prostate cancer patients.
What evidence suggests that hypofractionated proton radiation therapy might be an effective treatment for prostate cancer?
Research has shown that a shorter course of proton radiation therapy effectively treats prostate cancer. One study found that 86.3% of patients who received this treatment remained cancer-free five years later, indicating that most did not experience a recurrence during that period. In this trial, participants will receive hypofractionated proton radiation therapy tailored to their risk level, with separate treatment arms for low-risk and intermediate-risk prostate cancer. Additionally, proton therapy often causes fewer urinary side effects than traditional radiation. Another study demonstrated its effectiveness for patients with both low- and intermediate-risk prostate cancer. These findings suggest that this type of proton radiation can effectively treat prostate cancer while reducing side effects.12456
Who Is on the Research Team?
Curtis Bryant, MD, MPH
Principal Investigator
University of Florida Proton Therapy Institute
Are You a Good Fit for This Trial?
Men with prostate cancer who have a PSA level of 20 ng/ml or lower and a Gleason score between 2-7 can join this trial. They shouldn't have had previous prostate cancer surgery, pelvic radiation, certain intrapelvic surgeries, systemic chemotherapy for prostate cancer, or be on specific anticoagulants like Warfarin.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Radiation
Participants receive hypofractionated proton radiation therapy for prostate cancer
Follow-up
Participants are monitored for disease control and overall survival after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Hypofractionated Proton Radiation Therapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Florida
Lead Sponsor