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NOT YET RECRUITING
NCT07674771
EARLY_PHASE1

Response With Interim PSMA PET in Metastatic Castration-sensitive Prostate Cancer for Optimization of Adaptive Metastasis-directed Radiotherapy Delivery

Sponsor: University of Texas Southwestern Medical Center

View on ClinicalTrials.gov

Summary

The purpose of this study is to characterize the reduction in PSMA-avid tumor volume and metastasis-directed radiotherapy treatment intensity facilitated by PET PSMA-response adapted SABR for poly-metastatic castration sensitive prostate cancer.

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-10

Completion Date

2029-06-15

Last Updated

2026-08-24

Healthy Volunteers

No

Interventions

DRUG

Drug: 68-Ga PSMA11

0-3 months since initiation of ADT. Baseline PSMA PET imaging. 4-20 sites of metastasis by PSMA PET Will be injected/assessed in line with its FDA label. Other Name:

RADIATION

Adaptive stereotactic ablative radiotherapy (SABR)

Pre-plan 5 fraction SABR 35-40 Gy. SOC systemic therapy allows for ADT and ARSI intensification. Delivery of 3 pulses to all sites. Pulses delivered weekly.

DRUG

68Ga-PSMA-11

Repeat PSMA PET imaging at 6 months post-ADT initiation. Radiation of primary allows. Will be injected/assessed in line with its FDA label.

RADIATION

Adaptive stereotactive ablative radiotherapy (SABR)

Delivery of 2 additional pulses to all remaining PSMA PET visible sites

Locations (1)

University of Texas Southwestern Medical Center

Dallas, Texas, United States