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

NCT07674771 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-07-23

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Varian, a Siemens Healthineers Company

    collaborator INDUSTRY

  • Telix Pharmaceuticals (Innovations) Pty Ltd

    collaborator INDUSTRY

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • DANIEL YANG, MD · University of Texas Southwestern Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-15
Primary Completion
2029-06-15
Completion
2029-06-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07674771 on ClinicalTrials.gov