TheranosticTrials.org

Clinical Trial · NCT04452136

Expanded Access Protocol of 68Ga PSMA 11 PET Imaging of Prostate Cancer

Overview

This study provides expanded access to radiotracer Gallium 68 (68Ga)-prostate-specific membrane antigen (PSMA)-HBED-CC (68Ga-PSMA-11) with Positron Emission Tomography (PET) imaging for participants with intermediate and high risk prostate cancer before prostatectomy or for suspected biochemical recurrence of their prostate cancer. Compared to conventional imaging, 68Ga PSMA-HBED-CC might improve the ability to localize the sites of recurrent or metastatic disease, which helps with surgical and other treatment planning.

Sponsor

OHSU Knight Cancer Institute

Contacts

Nadine Mallak, M.D. (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT04452136

Drug / Compound

PSMA-11

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

Eligibility

Inclusion

  • If post-radical prostatectomy, PSA \> 0.2 ng/mL measured \> 6 weeks post-operatively and confirmatory persistent PSA greater than 0.2 ng/mL (AUA recommendation for biochemical recurrence).
  • If post-radiation therapy, PSA that is equal to or greater than a 2 mg/mL rise above PSA nadir (ASTRO recommendation for biochemical recurrence).
  • Karnofsky performance status (KPS) \>= 50 (ECOG/WHO 0, 1, or 2)
  • Planned prostatectomy with lymph node dissection
  • Biopsy-proven prostate adenocarcinoma
  • Must be treatment naïve (not have received neoadjuvant chemotherapy, radiation therapy, hormonal therapy, androgen deprivation therapy, or focal ablation techniques (e.g., HiFu)BIOCHEMICAL RECURRENCE
  • Not receiving any other investigational agents (i.e., unlabeled drugs or drugs under an IND for initial efficacy investigations
  • PLANNED PROSTATECTOMY
  • Intermediate to high-risk disease, defined as one of the following factors: PSA \> 10, T2b or greater, or a Gleason score of 7 or greater.
  • Pathologically proven prostate adenocarcinoma. Rising PSA after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).

Exclusion

  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • History of Stevens-Johnson syndrome
  • Known Paget's disease