A Study of MRI-guided High-dose Radiation Therapy in Prostate Cancer

January 28, 2026 updated by: Memorial Sloan Kettering Cancer Center

A Phase II Study of Radiotherapy to the Prostate and Dose Intensification to the Dominant Intra- Prostatic Lesion (DIL) Using Ultra-Hypofractionated, MR-Guided Radiotherapy

One of the usual approaches to treating intermediate-risk prostate cancer is a type of radiation therapy called SBRT (stereotactic body radiation therapy). SBRT delivers higher than standard doses of radiation over a lower number of treatment sessions. However, there is a 20% chance that intermediate-risk prostate cancer will come back after this treatment. The purpose of this study is to find out whether giving an even higher dose (a "boost" dose) of radiation directly to the main tumor and the standard dose of radiation to the rest of the prostate may cure the cancer or prevent it from coming back for a longer period of time while causing few side effects.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

91

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
      • Middletown, New Jersey, United States, 07748
        • Memorial Sloan Kettering at Monmouth (Limited Protocol Activities)
      • Montvale, New Jersey, United States, 07645
        • Memorial Sloan Kettering at Bergen (Limited Protocol Activities)
    • New York
      • Commack, New York, United States, 11725
        • Memorial Sloan Kettering at Suffolk-Commack (Limited Protocol Activities)
      • Harrison, New York, United States, 10604
        • Memorial Sloan Kettering at Westchester (Limited Protocol Activities)
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
      • Uniondale, New York, United States, 11553
        • Memorial Sloan Kettering at Nassau (Limited Protocol Activities)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Intermediate-risk prostate cancer patients will be eligible for this study. Risk groups will be assigned as per NCCN guidelines. Intermediate-risk patients will be defined as:

    • PSA 10-20 ng/ml or
    • Gleason score = 7 or
    • Clinical stage T2b/T2c or

  • Additionally, patients will be required to meet all of the following criteria:

    • Age ≥ 18
    • Karnofsky Performance Status (KPS) ≥ 80 (Appendix 1)
    • Prostate size ≤ 80 cc
    • Presence of a T2-visible prostatic lesion with maximum dimension of ≥ 0.5 cm and no more than one additional disease focus
    • MRI findings: Lesion may contact the capsular edge, possible extracapsular extension (ECE) permitted
    • International Prostate Symptom Score ≤ 15
    • Satisfy all MRI screening criteria and be willing to fill out the standard MRI screening form

Exclusion Criteria:

Patient will be excluded if they meet any one of the following criteria:

  • Gleason score >7
  • PSA >20
  • Prior or concurrent androgen deprivation therapy for prostate cancer MRI findings: suspicious for/probable ECE
  • MRI findings: >2 disease foci identifiable
  • Evidence of metastatic disease on bone scan or MRI/CT
  • MRI ineligibility due to: the presence of a cardiac pacemaker, defibrillator, or other implanted metallic or electronic device which is considered MR unsafe; severe claustrophobia; inability to lie flat for the duration of the study; etc.
  • Metallic implant or device in the pelvis that might distort the local magnetic field and compromise quality of mp-MRI
  • Lateral pelvic separation greater than 50 cm and/or anterior-posterior separation greater than 35 cm which are incompatible with MRCAT reconstruction
  • Contra-indications to receiving gadolinium contrast
  • KPS < 80
  • Pelvic or prostate MRI or CT (MRI preferred) evidence of radiographic T3, T4, or N1 disease
  • Prior history of transurethral resection of the prostate
  • Prior history of urethral stricture
  • Prior history of pelvic irradiation
  • History of inflammatory bowel disease
  • Unable to give informed consent
  • Unable to complete quality of life questionnaires

  • Abnormal complete blood count, including any of the following:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prostate cancer patients

Intermediate-risk prostate cancer patients will be eligible for this study. Risk groups will be assigned as per NCCN guidelines. Intermediate-risk patients will be defined as:

  • PSA 10-20 ng/ml or
  • Gleason score = 7
  • Clinical stage T2b/T2c
Radiation: Radiation Therapy
Patients enrolled in this study will undergo ultra-hypofractionated radiation utilizing MR guided, daily online adaptive planning. Patients will receive a standard dose of 8 Gy/fraction for five fractions for a total dose of 40 Gy to the prostate with a simultaneously-delivered boost of 9 Gy for five fractions (clinically non-standard dose of 45 Gy total) to a single dominant lesion with a maximum dimension of at least 0.5 cm, as determined on the pretreatment diagnostic T2 MRI imaging. In the setting of two similarly-sized "dominant" lesions, both will be boosted.
Other Names:
  • SBRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of pretreatment biopsy with post-treatment biopsy
Time Frame: 24 months
The primary outcome of efficacy will be studied using post -treatment biopsies. To demonstrate efficacy of dose escalation to the DIL, the investigators aim to reduce the positive post-treatment biopsy rates at 24 months for intermediate risk disease from 20% to 10%.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Victoria Brennan, MBBCH BAO, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 4, 2021

Primary Completion (Estimated)

August 4, 2026

Study Completion (Estimated)

August 4, 2026

Study Registration Dates

First Submitted

August 4, 2021

First Submitted That Met QC Criteria

August 4, 2021

First Posted (Actual)

August 9, 2021

Study Record Updates

Last Update Posted (Actual)

January 30, 2026

Last Update Submitted That Met QC Criteria

January 28, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-308

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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