Proton Therapy for Prostate Cancer

Recruiting in Palo Alto (17 mi)

Overseen byWilliam Barrett, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Cincinnati

No Placebo Group

Trial Summary

What is the purpose of this trial?This study uses photon radiation with a proton boost to treat prostate cancer. The purpose of this study is to determine if proton therapy as a boost following photon intensity modulated radiation therapy (IMRT) produces decreased toxicity as compared to conventional photon IMRT alone in the treatment of prostate cancer. Our secondary objective is to determine the effectiveness of this treatment regimen. Effectiveness will be determined by length of time to progression or recurrence of disease and overall survival. Patients on this study will be treated with a course of photon radiation therapy followed by a boost course of proton radiation.

Eligibility Criteria

Men over 18 with low (T1c-T2a, Gleason 6, PSA <10) or intermediate risk (T1c-T2c, Gleason 7 and/or PSA 10-20) prostate cancer can join. They must be able to consent and have a life expectancy of more than 10 years. Those with high-risk cancer, prior treatments like prostatectomy or brachytherapy, other cancers except non-melanoma skin cancer, or under hormone therapy cannot participate.

Inclusion Criteria

My prostate cancer is classified as low or intermediate risk.

I am 18 years old or older.

I have low risk prostate cancer.

+3 more

Exclusion Criteria

I am unable to sign the consent form by myself due to physical or mental reasons.

I am under 18 years old.

I have had cancer before, but not skin cancer.

+6 more

Participant Groups

The trial is testing if using proton radiation as an additional treatment after photon IMRT reduces side effects in treating prostate cancer compared to just photon IMRT. It also looks at how long patients stay disease-free and their overall survival after this combined treatment.

2Treatment groups

Experimental Treatment

Active Control

Group I: Prospective Treatment GroupExperimental Treatment1 Intervention

Proton Boost

Group II: Retrospective Comparison GroupActive Control1 Intervention

Retrospective patients previously treated with standard of care photon therapy. There is no patient interaction with this group. Data collection from medical records only.