Actively Recruiting
Personalized Radiotherapy for Individualized Treatment Strategies and Monitoring (PRISM): A Multi-cohort Platform Trial of Adaptive Radiotherapy Approaches in Multiple Cancer Types
Led by University of Texas Southwestern Medical Center · Updated on 2025-11-10
45
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to study personalized approaches to adapt standard radiotherapy treatments based on individual patient responses, focusing on feasibility, safety, and preliminary effectiveness. The trial includes multiple cohorts addressing different cancer types, such as extensive stage small cell lung cancer (ES-SCLC) and brain metastases from solid tumors. It explores how tailored radiotherapy combined with chemoimmunotherapy or stereotactic radiosurgery can potentially improve treatment outcomes while minimizing risks. Participants in Cohort A receive personalized ultrahypofractionated stereotactic ablative radiotherapy (PULSAR) targeted at thoracic tumors before cycles of chemoimmunotherapy. The radiotherapy is delivered in up to three pulses, timed before specific cycles, with the possibility to pause if a complete response occurs. In Cohort B, patients with brain metastases receive PULSAR delivered in two pulses of fractionated stereotactic radiosurgery, with the second pulse possibly omitted based on tumor size reduction observed via imaging after initial treatment. Throughout the study, participants undergo treatment planning, imaging assessments, and response evaluations to guide adaptive radiotherapy dosing. Safety, disease response, and radiotherapy dosing benefits are closely monitored over a five-year period. The study uses imaging to assess tumor changes that influence treatment decisions, aiming to reduce exposure to healthy tissue while maintaining control of cancer growth. Participants will be followed for safety and treatment outcomes during and after therapy.
CONDITIONS
Brief Title
Personalized Radiotherapy for Individualized Treatment Strategies and Monitoring (PRISM)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- ECOG performance status between 0 and 2 (for Cohort A)
- Diagnosed with extensive stage small cell lung cancer by tissue biopsy within 180 days (for Cohort A)
- Planned for or currently receiving standard chemoimmunotherapy (for Cohort A)
- Received no more than 3 cycles of chemoimmunotherapy at enrollment (for Cohort A)
- Able and indicated to receive thoracic radiotherapy (for Cohort A)
- Diagnosed with solid tumor malignancy with MRI-defined brain metastasis lesions (1-5 lesions) within 60 days (for Cohort B)
- Each brain metastasis lesion size between 2 and 5 cm, except brainstem lesions which may be 1.5 to 5 cm (for Cohort B)
You will not qualify if you...
- Prior thoracic radiotherapy (for Cohort A)
- Prior whole brain radiotherapy (for Cohort B)
- Prior surgical resection or focal radiotherapy of a target brain metastasis (for Cohort B)
- Presence of leptomeningeal disease (for Cohort B)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 3 months depending on cohort and treatment pulses
Participants receive personalized ultrahypofractionated stereotactic ablative radiotherapy (PULSAR) adapted to their cohort and tumor response, alongside standard chemoimmunotherapy for cohort A or fractionated stereotactic radiosurgery for brain metastases in cohort B.
Multiple visits including radiotherapy sessions and chemoimmunotherapy infusions; Cohort A involves up to 3 radiotherapy pulses before chemoimmunotherapy cycles; Cohort B involves 3 fractions in pulse 1, imaging at 4 weeks, and possibly 2 fractions in pulse 2
Trial Site Locations
Total: 1 location
1
Ut Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
Research Team
S
SARAH NEUFELD
N
NEIL DESAI, MD, MHS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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