A PHASE II TRIAL EVALUATING THE SAFETY AND EFFICACY OF MR-LINAC- GUIDED RADIOTHERAPY AS SALVAGE TREATMENT AFTER EXTERNAL BEAM RADIOTHERAPY RECURRENCE (TUMORNATOR II)

Brief description of study

This Phase 2 study is testing how using a special imaging technique called the Elekta Unity MR-linac system can be safe and effective for patients with prostate cancer that has not spread to other parts of the body after previous treatment with radiotherapy.

Patients will have special scans taken before the study treatment to help the study team determine the treatment planning and doses. All patients will then be treated using an MR-guided approach on the Elekta Unity MR-linac system.

The study team will collect tissue samples from all patients after treatment to see how the treatment is changing the tumor. All patients will have special scans taken and the study doctor will examine them to see how the patients are doing. All patients will be closely monitored for side effects and safety and followed every 6 months for up to 2 years after their treatment.


Clinical Study Identifier: s24-00856
ClinicalTrials.gov Identifier: NCT07142967
Principal Investigator: Michael J. Zelefsky.
Other Investigators: Victor Ricardo Adorno Febles, Andrew J Evans, Minas Platon Economides, Katie S. Murray, Madhur Nayan, James S Wysock, Anton Becker, Wei Phin Tan, Fang-Ming Deng, Thomas B. Daniels, Sungmin Woo, William C Huang, Peter B. Schiff, David R. Wise.


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