MedTrace Logo

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

NCT07142967 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2025-08-27

No results posted yet for this study

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.

Conditions

  • Intraprostatic Prostate Cancer

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.

Sponsors & Collaborators

Principal Investigators

  • Michael Zelefsky, MD · NYU Langone Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-15
Primary Completion
2027-08-01
Completion
2029-08-02
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07142967 on ClinicalTrials.gov