RecruitingPhase 1NCT07139990

Personalized Radiotherapy for Individualized Treatment Strategies and Monitoring (PRISM)

Personalized Radiotherapy for Individualized Treatment Strategies and Monitoring (PRISM): A Multi-cohort Platform Trial of Adaptive Radiotherapy Approaches in Multiple Cancer Types


Sponsor

University of Texas Southwestern Medical Center

Enrollment

45 participants

Start Date

Oct 28, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

To characterize feasibility, safety, and/or preliminary efficacy of personalized strategies to adapt standard radiotherapy treatments to individual patient responses.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (PRISM) is developing personalized radiotherapy approaches using biological monitoring. It has two groups: one for people with extensive-stage small cell lung cancer receiving standard chemotherapy plus immunotherapy, and another for people with solid tumors that have spread to the brain (1 to 5 brain metastases). **You may be eligible if...** - (Lung group) You are 18 or older with extensive-stage small cell lung cancer, currently receiving or planned for standard chemo-immunotherapy, and your doctor agrees you could benefit from radiation to the chest - (Brain group) You are 18 or older with a solid tumor cancer that has 1 to 5 brain metastases, each measuring 2 to 5 cm **You may NOT be eligible if...** - (Lung group) You have previously received radiation to the chest - (Brain group) You have previously received whole-brain radiation - You have more than 5 brain metastases or metastases outside the allowed size range - Your overall health status does not meet study requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONCohort A: Extensive Stage Small Cell Lung Cancer (ES-SCLC) Thoracic Tumor PULSAR (Personalized ultrahypofractionated stereotactic ablative radiotherapy)

Radiographic response-adapted thoracic tumor radiotherapy given as single doses ('pulses') before standard of care chemoimmunotherapy cycles. Adaptive Changes Allowed: Tumor target (size/shape), # of doses (reduction) Adaptive Changes Allowed: Tumor target (size/shape), # of doses (reduction)

RADIATIONCohort B: Brain metastasis PULSAR (Personalized ultrahypofractionated stereotactic ablative radiotherapy)

Intervention: Fractionated stereotactic radiosurgery (SRS, 5 doses total) for brain metastasis given in two "pulses" (3 fractions + 2 fractions) with second pulse adapted to interim radiographic response Adaptive Changes Allowed: Omission of 2nd "pulse" in \>=25% responders or tumor target size/shape change in remainder


Locations(1)

Ut Southwestern Medical Center

Dallas, Texas, United States

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NCT07139990


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