Proton Beam Therapy for Prostate Cancer

Recruiting at 1 trial location

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Mayo Clinic

Must not be taking: Chemotherapy

Disqualifiers: Metastasis, Inflammatory bowel 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

Compensation: Varies

Number of Visits: Unknown

Duration: 5 weeks

56 Participants Needed

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.

Research Team

Mark R. Waddle, MD

Principal Investigator

Mayo Clinic

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive hypofractionation proton beam therapy with concurrent treatment of the prostate and pelvic nodes

5 weeks

Follow-up

Participants are monitored for late grade ≥ 3 gastrointestinal (GI) and genitourinary (GU) toxicity, and disease-free survival

24 months

Long-term Follow-up

Participants are monitored for disease-free survival including freedom from PSA relapse

5 years

Treatment Details

Interventions

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

Trial Overview 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.

Participant Groups

Group I: Hypofractionation Proton beam therapy Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+