Proton Beam Therapy for Prostate Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines a specific type of radiation therapy, called proton beam therapy, for treating prostate cancer. The researchers aim to determine if a shorter, more intense treatment schedule is effective for men with high-risk or challenging cases of prostate cancer. Participants must have recently confirmed prostate cancer, no metastasis, and no extensive prior treatments for prostate cancer. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in prostate cancer treatment.
Do I need to stop my current medications for the trial?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on chemotherapy or have had androgen deprivation therapy for more than 6 months, you may not be eligible to participate.
What prior data suggests that proton beam therapy is safe for prostate cancer treatment?
Research has shown that hypofractionated proton beam therapy is generally well-tolerated by patients with prostate cancer. One study found that patients with low-risk prostate cancer received a similar treatment safely and effectively. Another study demonstrated that ultra-hypofractionated proton therapy worked well for both low- and intermediate-risk prostate cancer, with no major safety issues reported.
However, strong evidence specifically for hypofractionated proton therapy in more advanced prostate cancer remains insufficient. While early studies are promising, more research is needed to fully confirm its safety across different risk levels. Prospective participants should discuss these findings with their doctor to make a more informed decision about joining a clinical trial.12345Why do researchers think this study treatment might be promising for prostate cancer?
Researchers are excited about hypofractionation proton beam therapy for prostate cancer because it offers a more precise and potentially less harmful way to target cancer cells. Unlike traditional radiation therapy, which may take several weeks and involve a broader area, this method focuses energy directly on the prostate and pelvic nodes, potentially reducing damage to surrounding healthy tissue. Additionally, the hypofractionation approach means fewer treatment sessions are needed, which can be more convenient for patients and may result in fewer side effects. This precision and efficiency in treatment make it a promising option for improving patient outcomes.
What evidence suggests that hypofractionation proton beam therapy might be an effective treatment for prostate cancer?
Studies have shown that hypofractionated proton beam therapy works well for prostate cancer. For patients with low to intermediate risk, this method is both safe and effective, and it shortens treatment time. Proton therapy uses fewer sessions with higher doses, maintaining effectiveness while reducing overall exposure. This approach not only reduces treatment time but also precisely targets cancer cells, potentially lessening side effects. Research suggests that proton therapy could be promising for more aggressive prostate cancer cases, such as those studied in this trial.12467
Who Is on the Research Team?
Mark R. Waddle, MD
Principal Investigator
Mayo Clinic
Are You a Good Fit for This Trial?
Men over 18 with high risk or unfavorable intermediate risk prostate cancer, confirmed within the last 6 months. They should have specific clinical stages and PSA levels, good liver and kidney function, and a performance score indicating they can carry out daily activities. Excluded are those who've had long-term hormone therapy for cancer, bowel disease history, hip replacements, prior pelvic radiation or surgery on the prostate, other recent cancers except skin cancer that's not melanoma.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive hypofractionation proton beam therapy with concurrent treatment of the prostate and pelvic nodes
Follow-up
Participants are monitored for late grade ≥ 3 gastrointestinal (GI) and genitourinary (GU) toxicity, and disease-free survival
Long-term Follow-up
Participants are monitored for disease-free survival including freedom from PSA relapse
What Are the Treatments Tested in This Trial?
Interventions
- Hypofractionation Proton beam therapy with Concurrent Treatment of the Prostate and Pelvic Nodes
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor