Clinical Trial · NCT03444844

Biodistribution and Dosimetry of Ga-68 P16-093 in Prostate Cancer

Overview

Initial performance of Ga-68-P16-093 in prostate cancer patients including dosimetry and preliminary efficacy evaluation in BCR patients, and correlation of Ga-68-P16-093 uptake with tissue histopathology in intermediate to high risk primary prostate cancer patients.

Sponsor

Five Eleven Pharms Inc.

Phase

Phase 1/2

Contacts

Mark Green, PhD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT03444844

Drug / Compound

P16-093

Isotope(s):

Target(s):

PSMA

Ligand Class: Small Molecules

Chelator: HBED-CC

Eligibility

Inclusion

Patient is unable to tolerate remaining still on the bed of the PET camera, due to physical limitations or claustrophobia.
Gleason ≥ 4+3 OR
PSA ≥ 0.2 ng/mL
Gleason 3+4 with \>30% pattern 4 or ≥3 cores positive
Histologically confirmed prostate cancer with following Gleason scoring at biopsy:
Scheduled for radical prostatectomy (expected to occur within 60-days of scanning)
Inclusion Criteria (Cohort 1):
Prostate cancer patients presenting with rising PSA after radical prostatectomy for treatment if primary disease.
Significant acute or chronic medical, neurologic, or illness in the subject that, in the judgment of the Clinical Investigators, could compromise subject safety, limit the ability to complete the study, and/or compromise the objectives of the study

Exclusion

Exclusion criteria not yet provided.