TheranosticTrials.org

Clinical Trial · NCT03443609

Study of 68Ga-HBED-PSMA PET/CT and Conventional Imaging in Occult Biological Relapse Prostate Cancer

Overview

68Ga-HBED-CC-PSMA is a radiopharmaceutical allowing a new imaging modality for the detection of prostate cancer recurrences, used in recent years in clinical studies by some teams mainly in Europe (1-6 ). The aim of this study is to study the diagnostic performance of 68Ga-HBED-PSMA PET / CT in occult recurrent carcinoma (PCa) by prospectively comparing it to the standard techniques used in this indication: optimized bone scintigraphy with double TEMP / CT systematic and abdominopelvic MRI. The therapeutic impact and tolerance of this examination will also be evaluated. The expected results are a demonstration of the superiority of 68Ga-HBED-PSMA PET compared to the standard assessment, with a potential impact on the therapeutic management of patients

Sponsor

Institut Cancerologie de l'Ouest

Phase

N/A

Contacts

ROUSSEAU Caroline, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT03443609

Drug / Compound

PSMA-11

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

Eligibility

Inclusion

  • Value of the plasma concentration of the last PSA assay during the 4 months preceding D0: 0.05 ng / mL ≤ PSA \<1.6 ng / mL
  • Karnofsky ≥ 70 or ECOG 0-1
  • The patient has given his written consent.
  • Life expectancy of at least 6 months
  • Biologic recurrence documented by abnormal results in 2 assays of plasma PSA concentration in the same laboratory.
  • Diagnosis of histologically proven prostate cancer.
  • Patient having benefited from previous curative treatment (prostatectomy, radiotherapy, ultrasound, cryotherapy ...), with a significant decrease in the plasma concentration of PSA at the end of treatment (= indisputable PSA)
  • Patient affiliated to a social security scheme
  • Conventional imaging assessment already carried out, including at least one optimized skeleton scintigraphy with thoracoabdominopelvic TEMP / CT (or 18F-Choline TEP) and pelvic MRI (or abdominopelvic CT if contraindicated MRI) less than 6 weeks old. All of these tests must have been interpreted as "negative" or "questionable" (without "suggestive" or "suspect" aspects of malignancy) written by the imaging specialist.

Exclusion

  • Persons deprived of liberty or guardianship (including trusteeship),
  • Another progressive cancerous condition, except for basal cell cancers.
  • Agitation; impossibility to hold motionless for at least 1 hour, or known claustrophobia
  • Poor predictable compliance or inability to undergo medical follow-up of the test for geographical, social or psychological reasons,
  • Implementation of treatment (eg chemotherapy) or change of treatment (eg hormone therapy) since skeletal scintigraphy, abdominopelvic MRI or the last serum PSA test.
  • Acute inflammatory condition,
  • Radiotherapy, chemotherapy or other anti-tumor treatment during the 6 weeks preceding PET,