TheranosticTrials.org

Clinical Trial · NCT04716725

68Ga-PSMA-11 PET for the Diagnosis of Metastatic Castration Resistant Prostate Cancer

Overview

This phase II trial studies the use of 68Ga-PSMA-11 positron emission tomography (PET) in diagnosing patients with prostate cancer that continues to grow despite the surgical removal of the testes or medical intervention to block androgen production (castration resistant), and has spread to other places in the body (metastatic). 68Ga- PSMA-11 is a new imaging agent that may help get more detailed pictures of the tumor. This trial aims to see whether using 68Ga-PSMA-11 PET scans may help doctors learn more about where disease is located in the body.

Sponsor

University of California, San Francisco

Phase

Phase 2

Contacts

Ivan A de Kouchovsky, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT04716725

Drug / Compound

PSMA-11

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

Eligibility

Inclusion

  • Presence of one or more metastases by standard radiographic scans that is safely accessible to tumor biopsy in the judgment of treating clinician and/or Interventional Radiology.
  • No history of radiation therapy to the target metastatic lesion selected for tumor biopsy.
  • Platelets \> 75,000/ul and prothrombin time (PT) or institution normalized ratio (INR) and a partial thromboplastin time (PTT) \< 1.5 times the institutional upper limit of normal (ULN) within 14 days prior to biopsy.
  • Patients must have planned initiation of systemic treatment (sub-cohort A1), or ongoing systemic treatment (sub-cohort A2) for castration resistant prostate cancer within 12 weeks of baseline Ga-PSMA PET.
  • Patients who undergo optional metastatic tumor biopsy following completion of baseline Ga-PSMA PET must additionally meet all of the following criteria:
  • Patients must have progressive castration resistant prostate cancer, according to PCWG3 criteria.
  • Patients must have at least one metastatic lesion with PSMA uptake at or above the blood pool on their baseline PSMA PET scan.

Exclusion

Exclusion criteria not yet provided.