PSMA PET Response Guided SabR in High Risk Pca

Description:

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

PSMA-11

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