COMPPARE stands for “A Prospective COMparative Study of Outcomes with Proton and Photon RAdiation in PRostate CancEr (COMPPARE).” This study, which is funded by the Patient-Centered Outcomes Research Institute (PCORI) and approved by the University of Florida Institutional Review Board (IRB 201801001; PI: Nancy Mendenhall, MD), will compare the quality of life, side effects, and cure rates for prostate cancer patients treated with proton therapy or photon therapy. We will ask 3000 men between the ages of 30-85 across the US who will be treated with either protons or photons to participate in COMPPARE. Participants will answer brief surveys regarding treatment choice, quality of life, and side effects for at least 3 years. In addition, proton therapy patients can choose to participate in a randomized trial that will evaluate whether quality of life, side effects, and prostate cancer cure rates differ between patients receiving the standard therapy versus a shorter therapy.
Our goal is to answer the following patient-centered questions:
- How likely are men to experience different quality of life issues with protons versus photons?
- How likely are men to experience different side effects with either treatment?
- Which treatment will result in a better cure rate?
- Is a shorter treatment regimen as safe and effective as the standard treatment regimen?
In general, to be eligible for this study you must be:
- A man diagnosed with non-metastatic prostate cancer
- A candidate for radiation therapy
- Between the ages of 30-85 with a life expectancy ≥8 yrs
Your doctor can explain the study’s eligibility criteria in more detail.
If so, in Step 2, you give your consent to participate and register for the study.
Step 3: Complete the Pretreatment Questionnaires.
Step 4: Receive the radiation treatment that you and your doctor agree is best for you.*
Step 5: Complete Quality of Life and Side Effects Follow-up Questionnaires three months after radiotherapy and annually for at least three years and follow-up Assessments for PSA every six months after treatment.
*Proton therapy patients will also have the option of participating in a randomized controlled trial. Ask your physician for more information.
Currently, many insurers do not cover proton therapy for prostate cancer due to its higher cost and unanswered questions about its effectiveness compared to photon therapy. This study will directly compare the potential benefits and harms of protons versus photons. It will emphasize patient-centered outcomes and will help future patients make informed treatment decisions. The results will also provide insurers with the data needed to make coverage and policy decisions around the use of proton therapy for prostate cancer.
Patients will receive $50 for completing surveys before radiation begins and at follow-up visits for a total of up to $250 for the first 3 years of the study. But more importantly, by participating in this study patients will also be part of something bigger. You may help future patients make more informed treatment decisions regarding radiation therapy for their prostate cancer and potentially affect health care policy.
Talk to your doctor about this study to learn more. You can also contact our study team at firstname.lastname@example.org.