Status:
RECRUITING
Trial Evaluating the Safety and Efficacy Of MR-Linac-Guided Radiotherapy as Salvage Treatment After External Beam Radiotherapy Recurrence (TUMORNATOR II)
Lead Sponsor:
NYU Langone Health
Conditions:
Intraprostatic Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
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 tox...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 2 2029
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT07142967
Start Date
August 15 2025
End Date
August 2 2029
Last Update
August 27 2025
Active Locations (1)
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1
NYU Langone Health
New York, New York, United States, 10016