Clinical Trial · NCT02673151

68Ga-PSMA PET/CT in Detecting Prostate Cancer Recurrence in Patients With Elevated PSA After Initial Treatment

Overview

The purpose of this research study is to see if recurrent prostate cancer can be identified using a special procedure called a positron emission tomography (PET) scan. PET/CT is used to describe information regarding the function, as well as location and size of a tumor.

Sponsor

Stanford University

Phase

Phase 2/3

Contacts

Andrei Iagaru, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT02673151

Drug / Compound

PSMA-11

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

Eligibility

Inclusion

  • A rise of PSA measurement of 2 or more ng/mL over the nadir
  • Able to provide written consent
  • Karnofsky performance status of ≥ 50 (or Eastern Cooperative Oncology Group \[ECOG\] / World Health Organization \[WHO\] equivalent)
  • Post-radiation therapy -American Society for Radiation Oncology (ASTRO)-Phoenix consensus definition
  • Confirmatory persistent PSA greater than 0.2 ng/mL (total of two PSA measurements greater than 0.2 ng/mL)
  • PSA greater than 0.2 ng/mL measured 6 to 13 weeks after RP
  • Rising prostate-specific antigen (PSA) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy)
  • Histopathological proven prostate adenocarcinoma
  • Post radical prostatectomy (RP) - American Urology Association (AUA) recommendation

Exclusion

  • Investigational therapy for prostate cancer.
  • Unable to lie flat, still or tolerate a positron emission tomograpy (PET) scan.