Clinical Trial · NCT04734184

A Prospective Study on 18F-DCFPyL PET/CT Imaging in Biochemical Recurrence of Prostate Cancer

Overview

PYTHON is designed to establish the efficacy and safety of 18F-DCFPyL in comparison with that of 18F-fluorocholine, in patients with first biochemical recurrence (BCR) after initial definitive therapy (prostatectomy, external beam radiotherapy or brachytherapy) for histopathologically confirmed prostate adenocarcinoma per original diagnosis. PET/CT scans will be each interpreted by three independent masked experts who are not otherwise involved in the trial.

Sponsor

Unknown Organization

Phase

Phase 3

ClinicalTrials.gov

NCT04734184

Drug / Compound

DCFPyL

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

Fluorocholine

Isotope(s):
Target(s):
  • Phospholipid Metabolism
Ligand Class: Small Molecules

Eligibility

Inclusion

  • Male.
  • Histopathological proven prostate adenocarcinoma per original diagnosis.
  • Patient with social insurance cover.
  • Patient who can undergo all study procedures per Investigator's point of view
  • First suspected recurrence of prostate cancer based on rising prostate-specific antigen (PSA) after initial curative therapy with radical prostatectomy of PSA ≥ 0.2 ng/mL confirmed by a subsequent PSA value of ≥0.2 ng/mL or with radiation therapy (external beam or brachytherapy) of PSA \> 2 ng/mL above the nadir after therapy regardless of the serum concentration of the nadir.

Exclusion

  • Unable to lie supine for imaging
  • Treatment with Androgen Deprivation Therapy (ADT) in the past 30 days or ongoing
  • Treatment with colchicine in the past 8 days or ongoing
  • Participation in another clinical study within one month prior to inclusion
  • Subjects deprived of their freedom by administrative or legal decision or who are under guardianship
  • Uncooperative, in the Investigator's opinion.
  • Other active malignant tumour
  • Treatment with hematopoietic colony stimulating factors (CSF) in the past 5 days or ongoing
  • Patients displaying any of the following criteria will not be included:
  • History of adjuvant radiotherapy
  • History of previous salvage therapies (including salvage radiotherapy or salvage lymph node dissection)
  • Known allergy to investigational or reference products or to any excipients
  • History of cryotherapy, high-intensity focused ultrasound (HIFU)
  • ECOG \> 2
  • Unable to provide written consent (linguistic or psychological inability)