TheranosticTrials.org

Clinical Trial · NCT06044857

PSMA PET Response Guided SabR in High Risk Pca

Overview

Sequential cohort evaluation of ideal timing of imaging and treatment spacing to discern maximal PSMA (Prostate specific membrane antigen) PET (Positron Emission Tomography) response (PSMA-11 68Ga, Illucix) for adaptation of dominant intra-prostatic lesion tumor boost dose

Sponsor

University of Texas Southwestern Medical Center

Phase

Phase 1

Contacts

Neil Desai, MD MHS (PRINCIPAL_INVESTIGATOR)

Sarah Neufeld (CONTACT)

sarah.hardee@utsouthwestern.edu

214-645-8525

Liliana Robles (CONTACT)

liliana.robles@utsouthwestern.edu

214-645-8525

ClinicalTrials.gov

NCT06044857

Drug / Compound

PSMA-11

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules
Chelator: HBED-CC

Eligibility

Inclusion

  • Staging 68Ga PSMA-11 PET -CT or -MRI demonstrating a PSMA-avid primary intra-prostatic target lesion amenable at investigator discretion to dose boost

Exclusion

  • Prior curative intent local therapy (e.g. prostatectomy, radiotherapy, focal ablative therapy) for prostate cancer is not allowed, with following exceptions regarding androgen deprivation therapy (ADT)/anti-androgen therapy (AAT):Prior androgen deprivation therapy (ADT) allowed if \<3 month total duration and stopped \>=3 months prior to registration with demonstration of non-castrate testosterone recovery (\>50ng/dL) and meeting all other inclusion criteria.Ongoing androgen deprivation therapy (ADT) is allowed if \<=60 days total duration AND meeting following criteria:If GnRH agonist used (e.g. leuprolide), bicalutamide must have been used for at least 30 days +/-14 days from start of GnRH agonist.All other inclusion criteria.