NCT07142967 · NYU Langone Health
Trial Evaluating the Safety and Efficacy Of MR-Linac-Guided Radiotherapy as Salvage Treatment After External Beam Radiotherapy Recurrence (TUMORNATOR II)
What this study 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.
View original scientific description
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.
Interventions
RADIATION
Stereotactic Body Radiation Therapy (SBRT)
SBRT will be delivered with a prescription dose of 8 Gy x 5 fractions prescribed to the 95% isodose line encompassing the dominant recurrent intraprostatic lesion (DRIL) as seen on MRI and/or PET PSMA imaging plus 4mm (GTV+4mm=CTV\_40). Remainder of the prostate gland minus CTV\_40 (CTV\_25) will be prescribed to 5 Gy x 5 fractions at the 95% isodose line.
DRUG
Androgen Deprivation Therapy (ADT)
ADT would be given 0-1 months prior to planned SBRT to the prostate for total of 4-6 months. ADT will be administered via Leuprolide or Degarelix monthly injections or daily Relugolix pills.
Primary outcome measures
Late toxicity (after 90 days) radiation-associated genitourinary (GU) and gastrointestinal (GI) events
Time frame: Month 24
A serious toxicity event will be defined as any Grade 3 or higher genitourinary or gastrointestinal toxicity, based on NCI CTCAE v5.0.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
- New York, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 10, 2026 · Source of record for eligibility and locations