Hypofractionated Radiation for Prostate Cancer

Recruiting at 1 trial location

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Mayo Clinic

Must be taking: Androgen suppression

Must not be taking: Anticoagulants

Disqualifiers: Pelvic radiation, Chemotherapy, Rectal disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

52 Participants Needed

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.

Research Team

Carlos E. Vargas, M.D.

Principal Investigator

Mayo Clinic

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Androgen Suppression Therapy

Participants receive androgen suppression therapy subcutaneously or intramuscularly for up to 6 months before radiation therapy

6 months

Radiation Therapy

Participants undergo hypofractionated radiation therapy over 15-30 minutes every other day for 1-2 weeks, for 1-5 treatments

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Follow-up at 3 and 12 months, annually for 4 years, then every 2 years

Treatment Details

Interventions

• Hypofractionated Radiation Therapy

Trial Overview The 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

Group I: Group III (radiation therapy, androgen suppression therapy) Experimental Treatment 4 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 Treatment 4 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 Treatment 3 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:

• Soft tissue sarcoma
• Extremity soft tissue sarcoma

Approved in European Union as Hypofractionated Radiotherapy for:

• Soft tissue sarcoma
• Extremity soft tissue sarcoma

Approved in Canada as Hypofractionated Radiotherapy for:

• Soft tissue sarcoma
• Extremity soft tissue sarcoma

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+