Clinical Trial · NCT02919111

Gallium-68 PSMA-11 PET in Intermediate to High-risk Preprostatectomy Patients

Overview

The investigators are imaging patients with prostate cancer using a new PET imaging agent (Ga-68-PSMA-11) in order to evaluate it's ability to detection prostate cancer in patients with high risk disease prior to prostatectomy.

Sponsor

University of California, San Francisco

Phase

Phase 2/3

Contacts

Thomas Hope, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT02919111

Drug / Compound

PSMA-11

Isotope(s):

Target(s):

PSMA

Ligand Class: Small Molecules

Chelator: HBED-CC

Linker: Ahx

Eligibility

Inclusion

Planned prostatectomy with lymph node dissection.
Karnofsky performance status of greater than 50 (or Eastern Cooperative Oncology Group (ECOG) /World Health Organization (WHO) equivalent).
Diagnostic CT or MRI as part of the PET study or performed within one month of PSMA PET.
Intermediate to high-risk disease (as determined by elevated Prostate-specific antigen (PSA) \[PSA\>10\], T-stage \[T2b or greater\], Gleason score \[Gleason score \> 6\] or other risk factors).
Biopsy proven prostate adenocarcinoma.

Exclusion

Neoadjuvant chemotherapy or radiation therapy prior to prostatectomy.
Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam.
Androgen deprivation therapy or other neoadjuvant treatments prior to PET imaging and surgery.
Including focal ablation techniques (HiFu).