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

Solid Tumor, Adult Brain Metastases Small Cell Lung Cancer Extensive Stage

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

Inclusion Criteria11

Cohort A:
\>=18 years old
Performance status ECOG 0-2
Extensive stage small cell lung cancer diagnosed by tissue biopsy within 180 days of registration.
Patient must be planned for or receiving standard of care chemoimmunotherapy.
Patient must have received no more than 3 cycles by time of study enrollment.
Able and indicated according to investigator to receive thoracic radiotherapy
Cohort B:
years old
Diagnosis of solid tumor malignancy with MRI-defined brain metastasis lesions (1-5 lesions allowed) within 60 days of registration
Each brain metastasis lesion enrolled must be 2 - 5 cm, except brainstem lesions which may be 1.5 - 5cm in size.

Exclusion Criteria6

Cohort A:
⨀ Prior thoracic Radiotherapy
Cohort B:
Prior whole brain Radiotherapy
Prior surgical resection or focal radiotherapy of a target brain metastasis
Leptomeningeal disease

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