RecruitingInterventional

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)

NCT ID: NCT06542757Sponsor: NYU Langone HealthLast updated: 2026-03-11

Summary

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.

Arms & interventions

Radiation1.5 T Elekta Unity MR-Linac system
Patients will receive 9 Gy/fraction (45 Gy total) for five fractions to the DIL, while the remainder of the prostate will be treated to 30 Gy in 5 fractions.
DeviceHydrogel rectal spacer (SpaceOAR)
A rectal spacer will be placed one week prior to simulation to achieve a separation of approximately 1 cm between the prostate and anterior rectal wall to further minimize rectal toxicity in these patients. The hydrogel will remain in the body for about 12 weeks.

Outcome measures

Primary

Negative biopsy rate 24 months post-treatment
Outcome measure will be assessed via repeat biopsy of the dominant lesion as seen on mp-MRI
Time frame: 24 months post-treatment
Serious toxicity rate 24 months post-treatment
Outcome measure will be assessed using NCI CTCAE v5.0 for gastrointestinal and genitourinary toxicity.
Time frame: 24 months post-treatment

Secondary

Prostate Specific Antigen (PSA) relapse rate at 24 months post-treatment
Time frame: 24 months post-treatment
Proportion of patients with radiation-induced response in the dominant prostatic lesion 6 months post treatment
Time frame: 6 months post-treatment
Proportion of patients with radiation-induced response in the dominant prostatic lesion 24 months post treatment
Time frame: 24 months post-treatment
Change in International Prostate Symptom Score (I-PSS)
Time frame: Baseline, Month 3
Change in International Prostate Symptom Score (I-PSS)
Time frame: Baseline, Month 6
Change in International Prostate Symptom Score (I-PSS)
Time frame: Baseline, Month 12-18
Change in International Index of Erectile Function (IIEF) score
Time frame: Baseline, Month 3
Change in International Index of Erectile Function (IIEF) score
Time frame: Baseline, Month 6
Change in International Index of Erectile Function (IIEF) score
Time frame: Baseline, Month 12-18
Change in genomic classifier (GC) Decipher score
Time frame: Baseline, 6 months post-treatment
Change in GC Decipher score
Time frame: Baseline, 24 months post-treatment

Eligibility criteria

Sex: MaleAge: 18 Years and olderHealthy volunteers: No

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)

Study locations (1)

NYU Langone Health

New York, New York, 10016

Recruiting