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A prospective comparative study of outcomes with proton and photon radiation in prostate cancer
Investigator (PI): Mendenhall, Nancy
Performing Organization (PO): (Current): University of Florida, College of Medicine, Department of Radiation Oncology / (352) 265-0287
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2018
Final Year: 2027
Record Source/Award ID: PCORI/PCS-2017C1-6312
Funding: Total Award Amount: $11,507,757
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: Comparing Radiation Treatments for Localized Prostate Cancer PCORI has identified the need for large studies that look at real-life questions facing diverse patients, caregivers, and clinicians. In 2014, PCORI launched the Pragmatic Clinical Studies initiative to support large-scale comparative effectiveness studies focusing on everyday care for a wide range of patients. The Pragmatic Clinical Studies initiative funded this research project. This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final. What is the research about? Prostate cancer is one of the most common cancers and a leading cause of cancer death among men in the United States. About one-third of all men with prostate cancer get treatment with a type of radiation called photon therapy. This treatment can cause bowel and bladder damage and sexual dysfunction. These side effects can worsen patients’ quality of life. Proton therapy is another treatment option. But researchers don’t know how well proton therapy works compared with photon therapy or what dose of proton therapy works best. In this study, the research team is comparing photon therapy to proton therapy. The team wants to know how each treatment affects patients’ quality of life, side effects, and risk of cancer coming back. Also, the team is testing two different doses of proton therapy to see if shorter, higher dose treatment is as safe and effective as longer, lower dose treatment. Who can this research help? Doctors and patients can use these results when considering how to treat prostate cancer. Insurance companies may also use the results when considering the benefits and harms of these treatments. What is the research team doing? The research team is working with cancer clinics around the country to recruit men with localized prostate cancer, or cancer that hasn’t spread to other areas in the body. The team is recruiting 1,500 patients at clinics that provide photon therapy and 1,500 patients at clinics that provide proton therapy. All men in the study receive either photon or proton therapy as part of their regular care. The team is surveying patients before and during treatment and again three months and one, two, and three years later. The survey asks patients about their quality of life and treatment side effects. Every six months for three years, the team is also checking to see if the prostate cancer has come back. The 1,500 patients receiving proton therapy can choose to take part in another study. In this other study, the research team is assigning patients to receive one of two proton therapy regimens by chance. Half of the patients receive eight weeks of therapy with a standard dose. The other half receives four weeks of therapy with a higher dose at each treatment. The team wants to know whether quality of life, side effects, and cancer recurrence differ between standard therapy and higher dose therapy. Patients, caregivers, prostate cancer advocacy groups, insurers, and companies that make radiation equipment helped to design and are helping to conduct the study. Research methods at a glance Design Element Description Design Pragmatic clinical trial and randomized controlled trial Population 3,000 men ages 30–85 with localized prostate cancer and a life expectancy ≤8 years Interventions/ Comparators Photon therapy Proton therapy Proton arm 1: standard proton therapy 78.0 Gy (RBE) in 39 fractions Proton arm 2: hypofractionated proton therapy 60.0 Gy (RBE) in 20 fractions Outcomes Primary: prostate cancer quality of life (bowel, urinary, and sexual dysfunction symptoms) Secondary: toxicity of adverse events, prostate cancer recurrence Timeframe 2-year follow-up for primary outcome.
Abstract Archived: Problem: Prostate cancer is the most common form of cancer and a leading cause of cancer death in men in the US, with over 160,000 cases and 28,000 deaths occurring each year. Approximately one-third of all men with prostate cancer receive primary treatment with radiation therapy, which can cause short-term and long-term (permanent) bowel and bladder damage that leads to organ dysfunction and significantly impacts patient quality of life. The majority of radiation treatment is delivered using X-rays (commonly called intensity-modulated radiation therapy [IMRT]). Proton therapy is an alternative type of radiation, but its use in prostate cancer is controversial. Proton therapy has known physical properties that allow less radiation dose to be delivered to the bowel and bladder compared to IMRT. However, it is a more expensive treatment, and its effects on patient quality of life, organ dysfunction, and prostate cancer cure rates relative to IMRT are unknown. Objective: Our objective is to compare proton therapy versus IMRT with respect to quality of life, side effects, and cancer control outcomes in prostate cancer. Methods: Fifteen hundred patients treated with proton therapy will be compared to 1500 patients treated with IMRT from a total of 42 treatment centers across the US; patients between the ages of 30-80 with a life expectancy of >10 years and localized (non-metastatic) prostate cancer will be eligible to participate. The study will collect information on patient-reported quality of life, physician-reported and patient-reported side effects, and prostate cancer recurrence. We will use several statistical techniques to minimize the chance that differences between patients who receive proton therapy and IMRT will lead to misleading results about the comparative effects of the treatments on the study outcomes. In addition, the 1500 proton patients can choose to participate in a randomized trial where half of the patients will be randomly assigned to receive 8 weeks of treatment with a conventional treatment schedule (fractionation) and the other half will receive only 4 weeks of treatment with a higher dose per session (hypofractionation); this additional study will evaluate whether quality of life, side effects, and prostate cancer recurrence outcomes differ between patients receiving the longer conventional proton therapy versus the shorter hypofractionated proton therapy. Outcomes: A goal of the proposed study is to answer the following patient-centered questions: (1) How likely am I to experience different quality of life issues with proton therapy versus IMRT? (2) How likely am I to experience different side effects with proton therapy versus IMRT? (3) Given my prostate cancer, will proton therapy or IMRT result in a better cure rate? and (4) If I choose proton therapy, is shorter treatment as safe and effective as longer treatment? Another important goal is to assess whether quality of life, side effects, and cancer recurrence outcomes differ between proton therapy and IMRT. Specifically, we have engaged a minority engagement group to help enroll more black men, who have a disproportionate burden of prostate cancer, ensuring that our results are more generalizable. Importance to patients: Currently, many insurers do not cover proton therapy for prostate cancer due to its high cost and unanswered questions about its effectiveness compared to IMRT. This study will directly compare the potential benefits and harms of proton therapy versus IMRT, emphasizing patient-centered outcomes and providing patients with the necessary data to make informed decisions regarding treatment of their prostate cancer. In addition, our results will also provide insurers with the data needed to make coverage and policy decisions around the use of proton therapy for prostate cancer. If the study finds that proton therapy is no better (or actually worse) than IMRT, it will help patients avoid costly treatments and curtail the use of proton therapy in prostate cancer. On the other hand, if proton therapy decreases treatment-related side effects and provides better quality of life, this can lead to increased coverage of proton therapy and a significant benefit to prostate cancer patients. Patient and stakeholder engagement: We have collaborated with a large and diverse group of patients and other relevant stakeholders, including caregivers, prostate cancer advocacy groups, organizations that emphasize minority patients, insurers, and radiation equipment manufacturers, to design this study. Together, we identified proton therapy versus IMRT in prostate cancer to be a high-priority research topic, and subsequently developed relevant research questions and selected outcomes identified by patients as the highest priority and greatest need. Patients and other relevant stakeholders were involved in designing recruitment strategies to maximize participation and will continue to be closely involved throughout the study conduct, including engagement in interpretation of data analysis and results and dissemination and implementation of study findings.

MeSH Terms:
  • African Americans
  • Comparative Effectiveness Research
  • Humans
  • Male
  • Outcome Assessment, Health Care
  • Patient-Centered Care
  • * Photons
  • Prospective Studies
  • Prostatic Neoplasms /ethnology
  • /psychology /*radiotherapy
  • * Protons
  • Quality of Life
  • Radiotherapy /*methods
  • Radiotherapy, Intensity-Modulated
  • Randomized Controlled Trials as Topic
  • United States
  • X-Rays
Country: United States
State: Florida
Zip Code: 32610
UI: 20184425
CTgovId: NCT03561220
Project Status: Ongoing
Record History: ('2021: Project extended to 2027; Abstract archived and replaced. ',)