Radiation Therapy for Prostate Cancer

Palo Alto (17 mi)

Overseen byBrian J. Davis, 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

Trial Summary

What is the purpose of this trial?This phase II trial studies the side effects of radiation therapy (hypofractionated proton beam therapy or IMRT) for the treatment of prostate cancer that has come back (recurrent) or that has spread to a limited number of sites (oligometastatic) following primary localized treatment. Hypofractionated proton beam radiation therapy delivers smaller doses of radiation therapy over time and may kill more tumor cells and have fewer side effects. IMRT uses high energy x-rays to kill tumor cells and shrink tumors. This trial is being done to find out if a shorter course of radiation therapy is better with fewer side effects for patients with recurrent prostate cancer.

Eligibility Criteria

Men over 18 with recurrent prostate cancer limited to certain lymph nodes, who've had primary radiotherapy. They must have a good performance status (able to carry out daily activities) and no bone or visceral metastases, other recent malignancies, or conditions that prevent radiation therapy or informed consent.

Inclusion Criteria

My cancer is only in my pelvic or nearby lymph nodes.

My prostate cancer has been confirmed through a biopsy.

I am a man aged 18 or older.

My prostate cancer has returned after I had radiation therapy.

My cancer has returned and spread to my lymph nodes, confirmed by advanced PET scans.

My cancer has spread but only to a few places.

I am fully active and can carry on all my pre-disease activities without restriction.

Exclusion Criteria

My cancer has spread to my bones or internal organs.

I cannot undergo treatments that lower testosterone levels.

I do not have conditions like uncontrolled IBD that prevent radiation therapy.

I am not currently taking any cancer drugs.

My cancer has spread to lymph nodes beyond my pelvis.

Treatment Details

The trial is testing two types of radiation: Hypofractionated Proton Beam Therapy which gives smaller doses over time, and IMRT which uses high-energy x-rays. The goal is to see if a shorter course of radiation can effectively treat recurrent prostate cancer with fewer side effects.

2Treatment groups

Experimental Treatment

Group I: Arm II (IMRT)Experimental Treatment5 Interventions

Patients undergo IMRT 5 days a week over 5 weeks. Patients undergo PET scan, CT scan, MRI, and blood sample collection throughout the study.

Group II: Arm I (proton beam radiation therapy)Experimental Treatment6 Interventions

Patients undergo proton beam radiation therapy 5 days a week over 3 weeks. Patients undergo PET scan, CT scan, MRI, and blood sample collection throughout the study.

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

🇺🇸 Approved in United States as IMRT for: