A Study Comparing Proton And Photon Radiation Outcomes In Prostate Cancer Patients
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Mankato, Minnesota: 18-008447
- Rochester, Minnesota: 18-008447
- Jacksonville, Florida: 18-008447
- La Crosse, Wisconsin: 18-008447
- Eau Claire, Wisconsin: 18-008447
NCT ID: NCT03561220
Sponsor Protocol Number: COMPPARE
About this study
The purpose of this study is to determine if prostate cancer patients treated with proton therapy as compared to IMRT experience improved QOL (validated EPIC instrument measuring bowel, urinary, and sexual QOL).
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Diagnosis of adenocarcinoma of the prostate.
- Localized prostate cancer, as confirmed by staging with PSA, biopsy, Gleason score, DRE, and clinical stage.
- Low-risk, intermediate-risk, or high-risk disease, based on NCCN Prostate Cancer Risk Group Guidelines and Joint AUA/ASTRO/SUO Guidelines.
- If patient has high-risk disease, nuclear medicine bone imaging must be performed to document the absence of overt metastatic disease in bones.
- Candidate for definitive prostate radiotherapy (either IMRT or proton).
- If patient is to be treated with IMRT, all treatment must be planned with IMRT; if patient is to be treated with protons, all treatment must be planned with protons (including pelvic nodes if treated).
- No previous prostate cancer treatment, with the exception of short-term (≤ 6 months) ADT according to NCCN guidelines.
- Age 30-80 years old at the time of consent.
- Life expectancy estimate (LEE) of ≥10 years.
- ECOG/Zubrod Performance Status 0-2.
- Non-English speaking patients may be enrolled.
Exclusion Criteria:
- Findings of metastatic disease (nodal or distant, N1 or M1).
- Very low-risk or very high-risk prostate cancer based on NCCN Prostate Cancer Risk Group Guidelines and Joint AUA/ASTRO/SUO Guidelines.
- Prior prostate surgical procedure, including transurethral resection of the prostate (TURP) and GreenLight Laser Therapy.
- History of invasive rectal malignancy or other pelvic malignancy, regardless of disease-free interval.
- Active inflammatory bowel disease (i.e., patients requiring medical interventions or who are symptomatic) or documented history of inflammatory bowel disease requiring intervention.
- Prior pelvic RT for any reason.
- Documented lack of psychological ability or general health permitting completion of the study requirements and required follow-up.
- Documented diminished capacity to understand the risks and benefits of participation in research and to autonomously provide informed consent.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
Contact |
Mankato, Minn.
Mayo Clinic principal investigator Ron Smith, M.D. |
Closed for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
Rochester, Minn.
Mayo Clinic principal investigator Mark Waddle, M.D. |
Closed for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
Jacksonville, Fla.
Mayo Clinic principal investigator Bradford Hoppe, M.D., M.P.H. |
Closed for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
La Crosse, Wis.
Mayo Clinic principal investigator Abigail Stockham, M.D. |
Closed for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
Eau Claire, Wis.
Mayo Clinic principal investigator Now Bahar Alam, M.D. |
Closed for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
More information
Publications
Publications are currently not available