Hypofractionated Proton Therapy for Prostate Cancer
Trial Summary
What is the purpose of this trial?
This study is being proposed to evaluate the use of moderate hypofractionated proton therapy in low and intermediate risk prostate cancer patients. Quality of life outcomes as well as gastrointestinal and genitourinary early and late toxicities will be analyzed and compared to conventional proton therapy regimens. It is thought that this regimen will produce comparable findings and would result in substantial health care cost savings, as well as, be more convenient for patients.
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Hypofractionated Proton Therapy for Prostate Cancer?
Is hypofractionated proton therapy safe for humans?
How is hypofractionated proton therapy different from other treatments for prostate cancer?
Research Team
J. Ben Wilkinson, M.D.
Principal Investigator
Provision Center for Proton Therapy
Eligibility Criteria
Men over 18 with low or intermediate risk prostate cancer, PSA <20 ng/mL, ECOG status 0-1, no evidence of distant metastases or regional lymph node involvement. Eligible patients must have a Gleason Score <7 and clinical stage T1-T2c. Prior systemic therapy for prostate cancer disqualifies participation.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive hypofractionated proton therapy, 62 Gy (RBE) in 20 fractions of 3.1 Gy (RBE) over 4 weeks
Follow-up
Participants are monitored for safety, effectiveness, and quality of life outcomes after treatment
Treatment Details
Interventions
- Hypofractionated Proton Therapy
Hypofractionated Proton Therapy is already approved in United States, European Union, Japan for the following indications:
- Prostate cancer
- Brain tumors
- Spinal cord tumors
- Head and neck cancers
- Retroperitoneal sarcomas
- Prostate cancer
- Brain tumors
- Spinal cord tumors
- Head and neck cancers
- Eye tumors
- Prostate cancer
- Brain tumors
- Spinal cord tumors
- Head and neck cancers
- Pediatric cancers
Find a Clinic Near You
Who Is Running the Clinical Trial?
Provision Center for Proton Therapy
Lead Sponsor
Center for Biomedical Research, LLC
Collaborator