MR-Guided Radiotherapy for Prostate Cancer

Recruiting in Palo Alto (17 mi)

Overseen byMichael Zelefsky, M.D

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: NYU Langone Health

No Placebo Group

Trial Summary

What is the purpose of this trial?The purpose of this study is to assess the impact of this MR-guided radiotherapy on tumor control of the dominant intraprostatic lesion among patients with intermediate risk prostate cancer. This study of Radiotherapy to the Prostate and Dominant Lesion Using Ultra-Hypofractionated, MR-adaptive Radiation Therapy aims to evaluate tumor control after definitive ultra-hypofractionated external beam radiation therapy (including a simultaneously delivered high-dose boost to a dominant lesion as detected on prostate magnetic resonance imaging (MRI)) in patients with intermediate-risk prostate cancer. This will incorporate the use of multiparametric MRI for target segmentation and the use of the MR-linac with adaptive radiation planning to treat the prostate gland, incorporating a dose boost to the dominant intraprostatic lesion (DIL) that is visible on T2-weighted and diffusion-weighted imaging and de-escalation of dose to the remainder of the prostate.

Eligibility Criteria

This trial is for patients with intermediate-risk prostate cancer. Participants should have a dominant lesion within the prostate visible on MRI. Key eligibility criteria include having a specific type of prostate cancer and being suitable for MR-guided radiotherapy.

Inclusion Criteria

MRI findings: Lesion may contact the capsular edge, possible extracapsular extension (ECE) permitted

I can carry out normal activities without assistance.

My prostate is smaller than 90 cubic centimeters.

+5 more

Exclusion Criteria

MRI findings: suspicious for/probable ECE

I have received hormone therapy for prostate cancer.

My scans show cancer has spread to my bones.

+16 more

Participant Groups

The study tests ultra-hypofractionated, MR-adaptive radiation therapy targeting the dominant intraprostatic lesion (DIL) using an advanced MR-Linac system, along with a hydrogel rectal spacer to minimize damage to surrounding tissues.

1Treatment groups

Experimental Treatment

Group I: MRI-guided Intensity Modulated RadiotherapyExperimental Treatment2 Interventions

All patients will undergo the injection of a hydrogel rectal spacer (SpaceOAR) 1 week before simulation. Patients will undergo ultra-hypofractionated radiation utilizing MR-guided, daily online adaptive planning. Patients will receive 9 Gy/fraction for five fractions for a total dose of 45 Gy to the prostate DIL while the rest of the prostate will be treated to a minimum dose to the rest of the prostate of 30 Gy in five fractions. Radiation will be given every other day, Monday through Friday, until 5 treatments have been completed. Patients will be followed at three and six months after treatment, and every six months thereafter through month 24 (+/- 4 weeks).