Actively Recruiting
Trial Evaluating the Safety and Efficacy Of MR-Linac-Guided Radiotherapy as Salvage Treatment After External Beam Radiotherapy Recurrence (TUMORNATOR II)
Led by NYU Langone Health · Updated on 2025-08-27
28
Participants Needed
1
Research Sites
206 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Trial Evaluating the Safety and Efficacy Of MR-Linac-Guided Radiotherapy as Salvage Treatment After External Beam Radiotherapy Recurrence (TUMORNATOR II)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male aged 18 years or older
- Biopsy-confirmed recurrent intraprostatic prostate cancer after prior external beam radiotherapy
- Seminal vesicle involvement is allowed
- Recurrent disease confirmed with pathology and assigned Gleason score
- Serum testosterone level at least 50 ng/dL within 2 months before enrollment
- Prior androgen deprivation therapy allowed if testosterone level is above 50 ng/dL
- At least 4 weeks since major surgery
- Karnofsky Performance Scale (KPS) score 80% or higher or ECOG status 0-1
- Prostate volume less than 90 cc on MRI
- International Prostatism Symptom Score (IPSS) 20 or below
- Available for follow-up for at least 2 years, with possible extended follow-up up to 5 years
- Presence of T2 and/or DWI-visible prostatic lesion on multiparametric MRI
- Able to meet all MRI screening criteria and complete MRI screening forms
You will not qualify if you...
- History of prostate brachytherapy (low or high dose rate)
- Currently undergoing androgen deprivation therapy or taking anti-androgens
- Evidence of extraprostatic disease on CT, MRI, or PET scan
- One or more suspicious positive lymph nodes on imaging
- History of other cancers within 2 years except treated skin or superficial bladder cancer or any cancer in remission for at least 3 years
- Diagnosis of Crohn's disease or ulcerative colitis
- MRI ineligibility due to unsafe implanted devices, severe claustrophobia, or inability to lie flat
- Metallic implants in the pelvis affecting MRI quality
- Pelvic size incompatible with MRI reconstruction (lateral separation >50 cm or anterior-posterior >35 cm)
- Contraindications to gadolinium contrast or PSMA radioligand
- Karnofsky Performance Scale (KPS) below 80 or ECOG 2 or higher
- Grade 3 or higher toxicity after initial external beam radiation therapy
- Disease-free interval less than 2 years
- Transurethral Resection of Prostate (TURP) within the past year
- Prior high-intensity focused ultrasound or cryotherapy treatment
- History of urethral stricture
- Unable to provide informed consent
- Unable to complete quality of life questionnaires
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
Research Team
M
Michael Zelefsky, MD
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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