TheranosticTrials.org

Clinical Trial · NCT04614363

68 Ga-PSMA for High Risk Prostate Cancer

Overview

This is a prospective, single-center, open-label pilot study of 68GA-PSMA-11 given at a single time prior to PET/CT imaging in men with localized high risk prostate cancer or biochemical recurrence. The imaging agent (68 Ga-PSMA 11 will be administered on an outpatient basis. It will be administered prior to the PET/CT imaging. The objective is to evaluate the distribution of 68GA-PSMA-11 in tissues and to determine if this alters the planned clinical management.

Sponsor

Lawson Health Research Institute

Phase

Phase 1/2

Contacts

Brian Miles, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT04614363

Drug / Compound

PSMA-11

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

Eligibility

Inclusion

  • ECOG performance status 0-1
  • Post radical prostatectomy (RP), PSA greater than or equal to 0.2 ng/ml measured more than 6 weeks after RP.
  • All patients must have histopathological proven adenocarcinoma of the prostate
  • Post-radiation therapy, PSA that is equal to or greater than 2 ng/ml rise above PSA nadir
  • No evidence of other malignancy (except squamous or basal cell skin cancers)
  • Consent to use acceptable form of birth control following the imaging period (condoms for a period of seven days after injection if sexually active)A. Inclusion criteria specific for the pre-prostatectomy group:Untreated prostate Cancer with high-risk features, as defined as having at least one of the following criteria:i. PSA ≥ 20.0 ng/mL ii. ISUP Gleason Grade Group 3, 4 or 5 iii. Clinical stage T3B. Inclusion criteria specific for biochemical recurrence:(i) Histopathological proven prostate adenocarcinoma (ii)Rising PSA after definitive therapy with prostatectomy or radiation (therapy (external beam or brachytherapy).

Exclusion

  • Unable to tolerate a PET/CT (e.g. unable to lie flat)
  • Known allergic reactions to 68-Ga, or gadolinium-based contrast agents.
  • Treatment with another investigational drug or other intervention 2 years.
  • Patient has any medical, psychological or social condition that, in opinion of the investigator will make difficult for the participant to tolerate study intervention.