Proton Beam Therapy for Prostate Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byRyan M. Phillips, MD, PhD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Mayo Clinic

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?The study is to examine a moderate hypofractionation regimen of proton beam therapy for high risk or unfavorable intermediate risk prostate cancer. The prostate and seminal vesicles are treated with 6750 centigray (RBE) in 25 fractions (i.e. 270 centigray/fraction), while the regional pelvic nodes receive 4500 centigray (RBE) in 25 fractions (i.e. 180 centigray/fraction) simultaneously. The overall treatment time is 5 weeks.

Eligibility Criteria

Men over 18 with high risk or unfavorable intermediate risk prostate cancer, confirmed within the last 6 months. They should have specific clinical stages and PSA levels, good liver and kidney function, and a performance score indicating they can carry out daily activities. Excluded are those who've had long-term hormone therapy for cancer, bowel disease history, hip replacements, prior pelvic radiation or surgery on the prostate, other recent cancers except skin cancer that's not melanoma.

Inclusion Criteria

My prostate cancer is in an early or specific advanced stage with certain PSA levels.

Signed informed consent

I am a man aged 18 or older.

+6 more

Exclusion Criteria

I have not had cancer other than non-melanoma skin cancer in the last 5 years.

I have received chemotherapy before.

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

+6 more

Participant Groups

The trial is testing a proton beam therapy regimen where the prostate and seminal vesicles receive one dose while pelvic nodes get another at the same time. The goal is to see how well this works over a five-week period for treating certain stages of prostate cancer.

1Treatment groups

Experimental Treatment

Group I: Hypofractionation Proton beam therapyExperimental Treatment1 Intervention

Hypofractionation Proton beam therapy with Concurrent Treatment of the Prostate and Pelvic Nodes