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MR-Guided Radiotherapy for Intermediate-Risk Prostate Cancer

This study is looking at a new way to treat intermediate-risk prostate cancer using a special type of radiation therapy called MR-guided radiotherapy. You would receive radiation using the 1.5 T Elekta Unity MR-Linac system, which delivers a higher dose to the main tumor (dominant intra-prostatic lesion or DIL) within the prostate, and a lower dose to the rest of the prostate. A hydrogel rectal spacer (SpaceOAR) would also be placed to protect your rectum during treatment. The study aims to see how well this treatment controls the tumor and if it causes serious side effects after 24 months. You may be able to join if you are a man aged 18 or older with intermediate-risk prostate cancer, based on your PSA levels, Gleason score, or tumor stage. The study plans to enroll 91 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 91 participants.
What's involved
You would receive five radiation treatments. A hydrogel rectal spacer would be placed one week before your treatment planning, and it would stay in your body for about 12 weeks.
Compensation
Not stated in the trial record.
Follow-up
Your tumor control and serious toxicity will be measured 24 months after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06542757

Evaluation of Tumor Control Based on Serial Multiparametric MRI and Post-Treatment Biopsies For Patients Treated With Dose Intensification to the Dominant Intra-Prostatic Lesion (DIL) Using Ultra-Hypofractionated, MR-Guided Radiotherapy

Recruiting
NAAges 18+InterventionalTreatment
NYU Langone Health
~91 participants
Updated 2026-03-11 on ClinicalTrials.gov
What's tested:1.5 T Elekta Unity MR-Linac systemHydrogel rectal spacer (SpaceOAR)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Negative biopsy rate 24 months post-treatment
Measured over 24 months post-treatment
+1 more outcome measured

Conditions

Prostate Cancer

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Michael Zelefsky, M.D · PRINCIPAL_INVESTIGATOR · NYU Langone Health

Who to contact

Michael Zelefsky, M.D
[email protected]
212-263-4432
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

PSA 10-20 ng/ml or
Gleason score = 7 or
Clinical stage T2b/T2c (T2b: the tumor has spread to more than one-half of one side of the prostate, but not to both sides. T2c: the cancer has invaded both sides of the prostate) 2. Age \> 18 3. Karnofsky Performance Status (KPS) \> 80 4. Prostate size \< 90 cc 5. Presence of a T2-visible prostatic lesion with maximum dimension of ≥ 0.5 cm and no more than two additional disease foci with a documented Prostate Imaging Reporting and Data System (PIRADS) 4-5 lesion 6. MRI findings: Lesion may contact the capsular edge, possible extracapsular extension (ECE) permitted 7. International Prostate Symptom Score \< 18 8. Satisfy all MRI screening criteria and be willing to fill out the standard MRI screening form

Exclusion

Platelet count less than 75,000/ml
Hb level less than 10 gm/dl
White blood cell (WBC) less than 3.5/ml
Abnormal renal function tests (creatinine \> 1.5)

What this trial measures

  • Negative biopsy rate 24 months post-treatment24 months post-treatment

    Outcome measure will be assessed via repeat biopsy of the dominant lesion as seen on mp-MRI

  • Serious toxicity rate 24 months post-treatment24 months post-treatment

    Outcome measure will be assessed using NCI CTCAE v5.0 for gastrointestinal and genitourinary toxicity.