Trial Evaluating the Safety and Efficacy Of MR-Linac-Guided Radiotherapy as Salvage Treatment After External Beam Radiotherapy Recurrence (TUMORNATOR II)

Recruiting now · Not applicable

Conditions studied: Intraprostatic Prostate Cancer

In brief

The purpose of this study is to assess the impact of prostate-specific membrane antigen/positron emission tomography (PSMA/PET)-informed magnetic resonance (MR)-guided radiation therapy on serious toxicity outcomes in patients with biopsy-proven locally radiorecurrent prostate cancer. The primary aim is to evaluate the safety of delivering MR-Linac-guided stereotactic body radiotherapy (SBRT) after prior prostate external beam radiotherapy for recurrent disease, and assess urinary toxicity outcomes at 2 years.

Key facts

Study ID: NCT07142967
Run by: NYU Langone Health
People needed: 28
Starts: 2025-08-15
Expected to finish: 2030-08-02
Last updated by the study team: 2026-07-10

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

18 years of age or older male participants
Biopsy proven intraprostatic prostate cancer after prior definitive external beam radiotherapy (moderate hypofractionation or Stereotactic Body Radiation Therapy (SBRT) acceptable).
a. NOTE: Seminal vesicle involvement allowed
Pathology confirming recurrent disease must have evidence of viable cancer as indicated with pathology interpretation where a Gleason score can be assigned
Serum testosterone ≥ 50 ng/dL determined within 2 months prior to enrollment
a. Prior Androgen Deprivation Therapy (ADT) use acceptable if testosterone level >50ng/dL
At least 4 weeks must have elapsed from major surgery
Karnofsky Performance Scale (KPS) ≥ 80% or Eastern Cooperative Oncology Group (ECOG) 0-1
Prostate size as determined on MRI to be < 90 cc.
International Prostatism Symptom Score (IPSS) ≤ 20
Patient must be available for follow-up. After 2 years of follow-up, upon completion of post-treatment biopsy, telephone, and chart review-based follow-up will be acceptable for up to 5 years
Presence of a T2 and/or DWI-visible prostatic lesion on mpMRI
a. NOTE: Lesion visible on MRI required for enrollment but PSMA/PET avid lesion not required
Satisfy all MRI screening criteria and be willing to fill out the standard MRI screening form

You may not qualify if…

History of prostate brachytherapy (low dose rate or high dose rate)
Actively undergoing androgen deprivation therapy and/or anti-androgens at time of enrollment
CT or MRI or PET scan evidence of extraprostatic disease
Patients with one or more positive lymph nodes considered suspicious as determined by clinical assessment on MRI or CT or PET scan
History of another malignancy within the previous 2 years except for the following: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, currently in complete remission, or any other cancer that has been in complete remission for at least 3 years
Patients with Crohn's disease or ulcerative colitis
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 or PSMA radioligand
Karnofsky Performance Scale (KPS) < 80 or ECOG 2+
Grade 3 or higher toxicity experienced after the initial course of External Beam Radiation Therapy (EBRT)
Disease free interval < 2 years
Hx of Transurethral Resection Of Prostate (TURP) within the year
Prior high-intensity focused ultrasound (HIFU) or Cryotherapy
Prior history of urethral stricture
Unable to give informed consent
Unable to complete quality of life questionnaires

Where it is running

NYU Langone Health — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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