TheranosticTrials.org

Clinical Trial · NCT04085991

Two TraCer PositROn EmiSSion Tomography ComBination for Efficacy EstimatiOn of Prostate Specific Membrane Antigen Radioligand Therapy in Patients With Metastatic Prostate Cancer

Overview

Single-arm, open-label, phase II trial in 200 competent adult male patients with Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-3 and progressive metastatic prostate cancer, failing, failed, refused, not eligible for or no access to further approved lines of therapy. Patients will undergo sequential FDG positron emission tomography (PET) and 18F-DCFPyL PET to assess FDG/DCFPyL concordance fraction. Patients with DCFPyL/FDG concordance of 50% or greater will be treated with 131I-PSMA-1095 radioligand therapy (RLT). Best post-treatment serum prostate specific antigen response will be compared to concordance fraction.

Sponsor

Unknown Organization

Phase

Phase 2

Contacts

Stephan Probst, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT04085991

Drug / Compound

PSMA-1095

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules

DCFPyL

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules

FDG

Isotope(s):
Target(s):
  • Glucose Transport
Ligand Class: Small Molecules

Eligibility

Inclusion

  • ECOG performance status 0 - 3, inclusive
  • Under active medical oncology care
  • Serum prostate specific antigen ≥ 1 ng/ml at baseline or CT/MRI soft-tissue measurable disease as per RECIST v1.1
  • Documented metastatic adenocarcinoma of the prostate
  • Able to tolerate the physical requirements of two PET/CT scans including lying for up to 30 minutes
  • Life expectancy of at least 3 months as judged by the investigator
  • Failed, failing, refused, no access to or not eligible for any approved prostate cancer therapies including but not limited to: ADT, NAAD (e.g., abiraterone, enzalutamide, darolutamide or apalutamide), docetaxel, cabazitaxel, radium-223 and oligometastatic RTX
  • Progressive disease on any of: bone scan, CT, MRI or serum PSA as judged by the investigator
  • Male

Exclusion

  • Unmanageable claustrophobia
  • Medically unstable (e.g. acute cardiac or respiratory distress or hypotensive)
  • Platelet count \< 75 x109/L
  • Albumin \< 2.5 g/dL (25 g/L)
  • Total bilirubin \> 2 x ULN (unless in instances of Gilbert's disease)
  • Impaired organ function as evidenced by any of the following laboratory values:
  • Exceeding the weight limit of the PET/CT bed (approximately 400 lbs.) or who cannot fit through the PET/CT bore (approximately 70 cm diameter)
  • Hemoglobin \< 85 g/L
  • Absolute neutrophil count \< 1.5 x109/L
  • AST or ALT \> 2.5 x ULN (or \> 5.0 x ULN in the presence of liver metastases)
  • Prior hemi-body irradiation
  • Prior failure of PSMA RLT