Hypofractionated Radiation for Prostate Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Carlos E. Vargas, M.D. - Doctors and ...

Overseen byCarlos E. Vargas, M.D.

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

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well hypofractionated radiation therapy works in treating participants with prostate cancer high-risk features following radical prostatectomy. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects.

Eligibility Criteria

Men with prostate cancer showing high-risk features after surgery can join this trial. They should have no history of chemotherapy for prostate cancer, heart issues in the last 6 months, or major illnesses that could affect participation. No prior pelvic radiation or long-term androgen suppression therapy is allowed.

Inclusion Criteria

My cancer is at a specific stage according to my pathology report.

My prostate cancer has high-risk features like spread or PSA levels between 0.2 and <2.0 after surgery.

My PSA level is below 2 ng/ml, measured after surgery.

See 7 more

Exclusion Criteria

I have received chemotherapy for prostate cancer before.

Major medical, addictive or psychiatric illness which in the investigator's opinion, will prevent the consent process, completion of the treatment and/or interfere with follow-up. (Consent by legal authorized representative is not permitted for this study)

I have not had a heart attack or severe heart failure in the last 6 months.

See 6 more

Treatment Details

Interventions

Hypofractionated Radiation Therapy (Radiation)

Trial OverviewThe study tests if a shorter period of intense radiation therapy combined with hormone suppression can effectively treat prostate cancer post-surgery. It aims to see if this approach kills more tumor cells while causing fewer side effects.

Participant Groups

3Treatment groups

Experimental Treatment

Group I: Group III (radiation therapy, androgen suppression therapy)Experimental Treatment4 Interventions

Participants receive androgen suppression therapy as Group II for up to 18 months (at the discretion of the treating physician), then undergo hypofractionated radiation therapy over 15-30 minutes every other day over 1-2 weeks, for 1-5 treatments.

Group II: Group II (radiation therapy, androgen suppression therapy)Experimental Treatment4 Interventions

Beginning 8-10 weeks before radiation therapy, participants receive androgen suppression therapy SC or IM for up to 6 months (at the discretion of the treating physician). Participants then undergo hypofractionated radiation therapy as Group I.

Group III: Group I (hypofractionated radiation therapy)Experimental Treatment3 Interventions

Participants undergo hypofractionated radiation therapy over 15-30 minutes every other day over 2 weeks, for 5 treatments.

Hypofractionated Radiation Therapy is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Hypofractionated Radiotherapy for: