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

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: Prostate Cancer
• Intervention / Treatment: Radiation: Radiation Therapy

• Study Type: Interventional
• Enrollment (Actual): 91
• Phase: Phase 2

Contacts and Locations

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

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

How is the study designed?

Design Details

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

Number of Arms

1

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	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

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

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2021
• Primary Completion (Estimated): August 4, 2027
• Study Completion (Estimated): August 4, 2027

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): September 2, 2026
• Last Update Submitted That Met QC Criteria: September 1, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: prostate cancer; Memorial Sloan Kettering Cancer Center; SBRT; stereotactic body radiation therapy; 21-308
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Therapeutics; Radiotherapy
• 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