TheranosticTrials.org
Clarity Pharmaceuticals

Clinical Trial · NCT04839367

Positron Emission Tomography (PET) Imaging of Participants With Confirmed Prostate Cancer Using 64Cu-SAR-bisPSMA (PROPELLER)

Overview

The aim of this study is to determine the safety and tolerability of 64Cu-SARbisPSMA in participants with untreated, confirmed Prostate Cancer.

Sponsor

Clarity Pharmaceuticals

Phase

Phase 1

ClinicalTrials.gov

NCT04839367

Drug / Compound

SAR-bisPSMA

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

Eligibility

Inclusion

  • Have ≥1 of the following intermediate- to high-risk features:
  • ≥18 years of age;
  • Confirmation of Prostate Cancer by histopathology and planned radical prostatectomy;
  • Life expectancy \>3 months;
  • * Signed informed consent;

Exclusion

  • Any serious medical condition which the Investigator feels may interfere with the procedures or evaluations of the study;
  • * Prior prostatectomy or any other treatment for Prostate Cancer, including Androgen Deprivation Therapy and radiation therapy;
  • Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. However, participants with a prior history of malignancy that has been adequately treated and who have been disease free for more than 3 years are eligible, as are participants with adequately treated non-melanoma skin cancer, superficial bladder cancer;
  • Previous treatment with PSMA-targeted therapy within 3 months prior to enrolment, and administration of other investigational agents within 4 weeks prior to entering the study (except 68Ga-PSMA-11);
  • Known hypersensitivity to the components of 64Cu-SAR-bisPSMA;

Patient Education

Patient education not yet provided.

Publications

Publications not yet provided.

Locations

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