MR-Guided Radiotherapy for Prostate Cancer
Palo Alto (17 mi)Overseen byMichael Zelefsky, M.D
Age: 18+
Sex: Male
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
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
I can carry out normal activities without assistance.
My prostate is smaller than 90 cubic centimeters.
My prostate symptoms are mild to moderate.
My prostate cancer is classified as intermediate-risk.
I am older than 18.
My prostate cancer has a visible lesion larger than 0.5 cm and no more than two high-risk areas.
Exclusion Criteria
I have received hormone therapy for prostate cancer.
My scans show cancer has spread to my bones.
My prostate cancer has a Gleason score above 7.
I cannot have gadolinium contrast due to health reasons.
My health limits my daily activities significantly.
My scans show advanced prostate cancer.
I have a history of inflammatory bowel disease.
I am unable to understand and give consent for treatment.
I have had radiation therapy to my pelvic area before.
I have had surgery to remove part of my prostate.
I have had a urethral stricture in the past.
Treatment Details
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).
Find a clinic near you
Research locations nearbySelect from list below to view details:
NYU Langone HealthNew York, NY
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Who is running the clinical trial?
NYU Langone HealthLead Sponsor