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Clinical trial Recruiting at 1 site Interventional Ages 18 and up Men only

Evaluating MRI-guided radiotherapy for prostate cancer treatment

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 (TUMORNATOR I)

Run by NYU Langone Health · NCT06542757 · Data updated 2026-11-12

This study is testing if a new type of MRI-guided radiation therapy can help control tumors better in men with intermediate-risk prostate cancer.

Quick facts

Study typeInterventional
Ages18 Years and up
SexMen only
Enrollment91 (estimated)
SponsorNYU Langone Health
Academic / other
Drugs / interventionsRadiation
Locations1 site (New York, New York)
StatusRecruiting
StartedDecember 9, 2024
Main results expectedDecember 2027
Study endsDecember 2029
Registry record updatedMarch 11, 2026
Trial IDNCT06542757 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are men over 18 with intermediate-risk prostate cancer as defined by specific clinical criteria.

Probably not a fit

Patients with low-risk or high-risk prostate cancer, or those with significant comorbidities affecting treatment, may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study assesses the effectiveness of MR-guided radiotherapy in controlling tumors in patients with intermediate-risk prostate cancer. It utilizes a technique called ultra-hypofractionated external beam radiation therapy, which includes a high-dose boost to the dominant intraprostatic lesion identified through multiparametric MRI. The approach aims to optimize treatment by adapting radiation delivery based on real-time imaging, potentially improving outcomes for patients. The study will monitor tumor control following this innovative treatment method.

Why it matters

Potential benefit: If successful, this approach could lead to improved tumor control and outcomes for patients with intermediate-risk prostate cancer.

How similar studies have gone: Other studies utilizing MR-guided radiotherapy have shown promising results, suggesting that this approach may be effective in improving treatment outcomes.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Intermediate-risk prostate cancer patients will be eligible for this study. Risk groups will be assigned as per National Comprehensive Cancer Network (NCCN) guidelines. Intermediate-risk patients will be defined as:

   * 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 Criteria:

1. Gleason score \>7
2. PSA \>20 ng/mL
3. Prior or concurrent androgen deprivation therapy for prostate cancer
4. MRI findings: suspicious for/probable ECE
5. MRI findings: \>2 disease foci identifiable
6. Evidence of metastatic disease on bone scan or MRI/CT
7. 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.
8. Metallic implant or device in the pelvis that might distort the local magnetic field and compromise quality of mp-MRI
9. Lateral pelvic separation greater than 50 cm and/or anterior-posterior separation greater than 35 cm which are incompatible with MR for Calculating ATtenuation (MRCAT) reconstruction
10. Contra-indications to receiving gadolinium contrast
11. KPS \< 80
12. Pelvic or Prostate MRI or CT (MRI preferred) evidence of radiographic T3, T4, or N1 disease
13. Prior history of transurethral resection of the prostate
14. Prior history of urethral stricture
15. Prior history of pelvic irradiation
16. History of inflammatory bowel disease
17. Unable to give informed consent
18. Unable to complete quality of life questionnaires
19. Abnormal complete blood count, including any of the following:

    * 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)

Where it's running

  • NYU Langone Health
    New York, New York, United States     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.