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

Phase 2

Recruiting

• Conditions: Prostate Cancer
• Interventions: Radiation: Radiation Therapy

• Registration Number: NCT04997018
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-04
• Study First Submitted: 2021-08-04
• Study First Submitted QC: 2021-08-04
• Study First Posted: 2021-08-09
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-18
• Primary Completion: 2026-08-04
• Study Completion: 2026-08-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 91

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prostate cancer patients	Radiation Therapy	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

Primary Outcome Measures

Name	Time	Method
Comparison of pretreatment biopsy with post-treatment biopsy	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%.

Trial Locations

Locations (2)

Memorial Sloan Kettering Cancer Center (All Protocol Activities); 🇺🇸 New York, New York, United States

Victoria Brennan; 🇺🇸 Uniondale, New York, United States