TheranosticTrials.org

Clinical Trial · NCT03623425

Comparison of PET With 68GA-PSMA-11 and 18F-Fluorocholine for Recurrence in Men With Prostate Cancer

Overview

As choline transport and phosphorylation are upregulated in most cancers, including prostate cancer, positron emission tomography (PET) with choline tracers has found widespread use to detect recurrent disease. However, choline metabolism is not increased in a significant number of cases, probably explaining why this imaging method has been reported to be weakly sensitive and specific fro the detection of prostate cancer lesions, especially at low prostate-specific antigen (PSA) levels. By contrast, prostate-specific membrane antigen (PSMA) is overexpressed in most prostate cancer, suggesting that 68Ga-labelled PSMA ligands could be superior to choline tracers. A meta-analysis published in 2016 (Perera M. and al.), which included 18 studies, of which five reported histolopathologic correlation data for 68Ga-PSMA PET-positive lesions, indicated favourable sensitivity and specificity profiles of 68Ga-labelled PSMA ligands compared to choline-based PET imaging techniques.

Sponsor

Central Hospital, Nancy, France

Phase

Phase 3

Contacts

Véronique ROCH, MSc (CONTACT)

v.roch@chru-nancy.fr

+33 3 83 15 42 76

Pierre OLIVIER, MD, PhD (CONTACT)

p.olivier@chru-nancy.fr

+ 33 3 83 15 39 11

Pierre OLIVIER, MD, PhD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT03623425

Drug / Compound

PSMA-11

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

FCH

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

Eligibility

Inclusion

  • Patients able to come for PET exams
  • Rising prostate-specific antigen (PSA) after curative treatment of prostate cancer (radical prostatectomy or radiation therapy). Following definitions will apply:
  • After radiation therapy: PSA increased by 2 ng/ml above nadir value
  • Estimated life-expectancy \> 6 months
  • Patient who have developed prostate cancer, and underwent radical treatment by prostatectomy or radiotherapy.
  • Residual disease =
  • After surgery: two sequential PSA values \>0.2 ng/ml
  • Progressive disease =
  • PSA doubling time ≤ 6 months irrespective of initial PSA value
  • Person undergone the medical examination adapted to research
  • After surgery: positive PSA immediately after surgery or positive surgical margin
  • Biochemical recurrence =
  • Patients who understood the principle and modalities of the study
  • PSA\<10 ng/ml at inclusion
  • Patients physically and psychologically able to participate to the study
  • Patients affiliated to or beneficiary of a social security plan
  • After radiation therapy: two sequential PSA \>0.2 ng/ml (to avoid false positive)
  • Patients with a positron emission tomography with 18F-Fluorocholine (PET 18F-Fcholine) requested, as part of routine care.

Exclusion

  • Known hypersensitivity to the active substance or to any excipient of the IMP
  • Exposure to another IMP within 60 days prior to inclusion
  • Drug or alcohol dependence, serious current illness, mental disorder or any circumstance which, in the opinion of the investigator, could interfere with the conduct or interpretation of the study
  • Person referred in articles L.1121-7 and L.1121-8 of the Public Health Code:
  • Patients with a history of malignant pathology (except for basal-cell cutaneous carcinoma)
  • Person deprived of liberty for judicial or administrative decision, Person under psychiatric care according to articles L. 3212-1 and L. 3213-1.
  • Adult person under legal protection (any form of public guardianship)
  • Adult person incapable of giving consent
  • Minor person (non-emancipated)
  • Patients with known allergy to furosemide or sulfonamides. Other contraindications to furosemide do not apply to patients for whom the product will be used as a single dose