TheranosticTrials.org

Clinical Trial · NCT04391556

Interest of PET-PSMA Imaging Potentialised by Androgen Blockade in Localized Prostatic Adenocarcinoma

Overview

Evaluation of the interest of PET-PSMA imaging potentiated by androgen blockade in patients with biological relapse or persistent biological disease of a localized prostatic adenocarcinoma after initial treatment

Sponsor

Centre Leon Berard

Phase

Phase 2

Contacts

David KRYZA, MD (PRINCIPAL_INVESTIGATOR)

Anne-Laure GIRAUDET, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT04391556

Drug / Compound

PSMA-11

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

Eligibility

Inclusion

  • Diagnostic recurrence assessment by any information or examination carried out since the ascension of the PSA, not having revealed local recurrence or lymph node lesions which may benefit from to external radiation
  • Hormone-naive patients, initially treated curatively by prostatectomy for prostate adenocarcinoma and having a first or new biological recurrence (PSA greater than 0.2 ng/ml; confirmed on at least two successive dosages in the last 12 months) OR Hormone-naive patients, initially treated curatively by external radiotherapy or by brachytherapy for prostate adenocarcinoma and having a biological recurrence (PSA Nadir + 2ng/ml ; confirmed on at least two successive dosages in the last 12 months ) OR hormone-naive patients treated by surgery or external radiotherapy or brachytherapy for prostate adenocarcinoma but with persistent biological disease (PSA detectable after prostatectomy, or unchanged or increasing PSA after external radiotherapy or brachytherapy);

Exclusion

  • Patient already treated by hormonotherapy;
  • Patient under protection of justice (Under tutorship, curatorship or deprived of liberty)
  • Significant cardiovascular affection such as myocardial infarction within the last 6 months preceding inclusion, severe rhythm disturbances, stroke within 6 months prior to inclusion, prolonged corrected QT interval with QTc \> 450 msecs according to Bazett formula;
  • Impossibility to comply with the study follow-up for geographical or psychic reasons.
  • Formal contraindication to hormonotherapy;
  • Formal contraindication to the Lasilix administration during the PET exams: Hypersensitivity to Furosemide or to one of the excipients, functional acute renal insufficiency, hepatic encephalopathy, urinary tracts obstruction, hypovolemia or dehydration, severe hypokalemia, severe hyponatremia, hepatitis in evolution and severe hepatocellular insufficiency in haemodialysis patient and patient presenting a severe renal insufficiency (creatinine clearance \<30 ml / min) due to the risk of accumulation of furosemide, which is then mainly eliminated by the biliary route;
  • Formal contraindication to external radiotherapy