Proton Therapy vs. Photon Radiation for Prostate Cancer (COMPPARE Trial)

Palo Alto (17 mi)

Overseen byNancy P. Mendenhall, MD

Age: 18+

Sex: Male

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

Waitlist Available

Sponsor: University of Florida

No Placebo Group

Trial Summary

What is the purpose of this trial?This study is a large, prospective, pragmatic, controlled comparison of patient-centric outcomes \[quality of life (QOL), toxicity, and disease control\] between parallel cohorts of men with prostate cancer treated simultaneously at proton therapy facilities and at geographically similar conventional (photon-based) radiation facilities using intensity-modulated radiation therapy (IMRT) techniques.

Eligibility Criteria

Men aged 30-85 with localized prostate cancer and a life expectancy of at least 8 years can join. They must have no history of invasive pelvic cancers, prior prostate cancer treatments (except certain therapies for benign conditions), or metastatic disease. Participants need to be physically able to complete the study and give informed consent.

Inclusion Criteria

My prostate cancer is localized and has been confirmed with specific tests.

I've had a bone scan to check for cancer spread if my disease is high-risk.

I have been diagnosed with prostate adenocarcinoma.

I am between 30 and 85 years old and expected to live 8 more years or longer.

I am a candidate for specific prostate cancer radiation treatment.

I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

My cancer has spread to nearby lymph nodes or other parts of my body.

I have difficulty understanding the risks and benefits of research studies.

My prostate cancer is classified as very high-risk.

I have had cancer in my pelvis area before.

I have active symptoms of inflammatory bowel disease.

I have had radiation therapy to my pelvic area before.

Treatment Details

This trial compares quality of life, toxicity, and disease control between proton therapy and conventional photon-based IMRT in treating prostate cancer. Patients are treated at different facilities but under similar standards to see which method is more effective.

4Treatment groups

Experimental Treatment

Active Control

Group I: Standard Proton TherapyExperimental Treatment1 Intervention

78.0 Gy (RBE) in 39 fractions. This is Arm 1 of the embedded randomized trial.

Group II: Hypofractionated Proton therapyExperimental Treatment1 Intervention

60.0 Gy (RBE) in 20 fractions This is Arm 2 of the embedded randomized trial.

Group III: IMRT (Photon)Active Control1 Intervention

As this trial is pragmatic, all treatment will be standard of care.

Group IV: Proton Therapy Standard of CareActive Control1 Intervention

As this trial is pragmatic, all treatment will be standard of care.