Actively Recruiting
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
Led by NYU Langone Health · Updated on 2026-03-11
91
Participants Needed
1
Research Sites
259 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with intermediate-risk prostate cancer defined by PSA 10-20 ng/ml, Gleason score 7, or clinical stage T2b/T2c
- Age over 18 years
- Karnofsky Performance Status greater than 80
- Prostate size less than 90 cc
- Presence of a T2-visible prostatic lesion at least 0.5 cm in size and no more than two additional PIRADS 4-5 lesions
- MRI lesion may contact capsular edge or have possible extracapsular extension
- International Prostate Symptom Score less than 18
- Ability and willingness to complete MRI screening form
You will not qualify if you...
- Gleason score higher than 7
- PSA greater than 20 ng/mL
- Prior or current androgen deprivation therapy for prostate cancer
- MRI findings suspicious for or probable extracapsular extension
- More than two disease foci visible on MRI
- Evidence of metastatic disease on bone scan or MRI/CT
- MRI ineligibility due to unsafe implanted devices, severe claustrophobia, or inability to lie flat
- Metallic implants in pelvis affecting MRI quality
- Pelvic size incompatible with MRI reconstruction (lateral separation > 50 cm or anterior-posterior > 35 cm)
- Contraindications to gadolinium contrast
- Karnofsky Performance Status less than 80
- Radiographic evidence of T3, T4, or N1 disease on pelvic imaging
- Prior transurethral resection of the prostate
- History of urethral stricture
- Previous pelvic irradiation
- History of inflammatory bowel disease
- Unable to give informed consent
- Inability to complete quality of life questionnaires
- Abnormal blood counts or renal function (platelets < 75,000/ml, hemoglobin < 10 gm/dl, white blood cells < 3.5/ml, creatinine > 1.5)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
Research Team
M
Michael Zelefsky, M.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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