XCancer

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

Description:

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.

Sponsor:

University of Texas Southwestern Medical Center

Phase:

Early Phase 1

Contacts:

SARAH NEUFELD, MS, MBA (CONTACT)

sarah.hardee@utsouthwestern.edu

214 645 8525

DANIEL YANG, MD (CONTACT)

daniel.yang@utsouthwestern.edu

214 645 8525

DANIEL YANG, MD (PRINCIPAL_INVESTIGATOR)

Government Study Link:

NCT07674771 - Click here to see study on

ClinicalTrials.gov

PSMA-11

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules
Chelator: HBED-CC
Inclusion
  • 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).
  • 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).
  • History of pathologically confirmed prostate cancer.
Exclusion
  • 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.
  • Prior radiotherapy to any metastases currently targeted for therapy or overlapping regions.
  • Subjects may not be receiving any other PSMA-directed investigational agents for the treatment of the cancer under study.