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

Starting soon · Early Phase 1

Conditions studied: Prostate Cancer, Castration Sensitive Prostate Cancer, Metastatic Prostate Cancer, Adaptive Radiotherapy

In brief

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 facts

Study ID

NCT07674771

Run by

University of Texas Southwestern Medical Center

People needed

30

Starts

2026-07-15

Expected to finish

2029-06-15

Last updated by the study team

2026-07-23

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• History of pathologically confirmed prostate cancer.
• Age >=18 years.
• Performance status ECOG 0-2.
• Staging 68Ga PMSA-11 PET/CT showing 4-20 sites of metastasis from prostate cancer within <=90 days prior to registration. This scan ideally should be performed before initiation of androgen deprivation therapy (ADT).
• At the discretion of the treating investigator, it is believed that it is safe to treat all sites of disease using SABR.
• All men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of standard of care SABR and for a period of time of 6 months thereafter as per standard guidelines. Should a patient's partner become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• Ability to understand and the willingness to sign a written informed consent.
• Planned for standard systemic therapy for metastatic prostate cancer to include androgen deprivation therapy (ADT). Upfront Docetaxel should not be planned (See section 4.1.2).

You may not qualify if…

• Prior radiotherapy to any metastases currently targeted for therapy or overlapping regions.
• Patient with metastatic lesions involving the gastrointestinal tract, specifically, invading esophagus, stomach, or intestines will be excluded. Patients with ultra-central metastatic lesions defined as 1 cm from the trachea and main bronchi will be excluded.
• Serious medical co-morbidities precluding safe delivering of radiotherapy to poly-metastatic sites. This includes interstitial lung disease for patients undergoing SABR to thoracic sites and ulcerative colitis or Crohn's disease requiring systemic immunosuppressive therapy for patients undergoing SABR to GI sites.
• Subjects may not be receiving any other PSMA-directed investigational agents for the treatment of the cancer under study.
• History of allergic reactions to PMSA-11 68Ga imaging agent.
• Uncontrolled intercurrent illness or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements.

Where it is running

• University of Texas Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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