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RECRUITING
NCT07142967
NA

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

Sponsor: NYU Langone Health

View on ClinicalTrials.gov

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 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 Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

28

Start Date

2025-08-15

Completion Date

2029-08-02

Last Updated

2025-08-27

Healthy Volunteers

No

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.

Locations (1)

NYU Langone Health

New York, New York, United States