TheranosticTrials.org

Clinical Trial · NCT03073395

Preliminary Evaluation of Uptake of [68Ga]P16-093 in Metastatic Prostate and Renal Cancer

Overview

An phase I study to evaluate the uptake of \[68Ga\]P16-093 in known or suspected metastatic prostate or renal cancer to establish the feasibility of using \[68Ga\]P16-093 to image PSMA expressing cancer. Measurement of the whole body biodistribution of \[68Ga\]P16-093 in prostate cancer patients post primary curative-intent treatment with stable PSA to generate human radiation dosimetry data.

Sponsor

Five Eleven Pharms Inc.

Phase

Phase 1

ClinicalTrials.gov

NCT03073395

Drug / Compound

P16-093

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

Eligibility

Inclusion

  • Prostate cancer with known or suspected recurrent or metastatic disease based on clinical imaging (e.g. CT, bone scan, MRI, ultrasound, FDG PET/CT, FACBC PET/CT) within 12 months of screening. If subject is post curative-intent local treatment (e.g. radical prostatectomy, local radiotherapy, brachytherapy) they must have had no intervening change in cancer treatment. OR
  • Renal Cell cancer with known or suspected metastatic disease based on clinical imaging (e.g. CT, bone scan, MRI, ultrasound, FDG PET/CT)
  • History of histologically confirmed cancer that meets criteria for either a) or b)

Exclusion

  • Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
  • Estimated creatinine clearance (eGFR) \< 30 mL/min (calculated from serum creatinine result within 30 days of screening)
  • Estimated creatinine clearance (eGFR) \< 30 mL/min (calculated from serum creatinine result within 30 days of screening)
  • Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
  • Androgen deprivation therapy (ADT) within 3 months prior to screening
  • Chemotherapy or radiation therapy within 2 weeks of screening
  • Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful completion of the study
  • If clinical imaging (e.g. bone scan, CT, MRI, ultrasound, PET/CT) has been done within 3 months of screening as part of standard clinical surveillance it must be negative or equivocal for sites of recurrent or metastatic disease (clinical imaging is not required for enrollment)
  • Post-Prostatectomy (with or without adjuvant RT): PSA level that is \< 0.2 ng/mL measured over at least 2 consecutive tests OR
  • Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful completion of the studyBIODISTRIBUTION GROUP:Inclusion Criteria:
  • History of prostate cancer that is post curative-intent local treatment (e.g. radical prostatectomy, local radiotherapy, brachytherapy) with clinical PSA levels that meet one of the following criteria
  • Post-Radiotherapy: PSA level that has not risen from nadir measured over at least 2 consecutive tests
  • Chemotherapy or radiation therapy within 2 weeks of screening