TheranosticTrials.org

Clinical Trial · NCT03313726

The Effect of ADT on PSMA-PET.

Overview

Phase A: To describe and to determine the maximum standardised uptake values (SUV) in prostate specific membrane antigen positron emission tomography (PSMA-PET) before ADT and 7, 14 and 28 days after ADT. Phase B: To validate phase A results by comparing the PSMA-PET findings to histopathological analysis of regional lymph nodes acquired from radical prostatectomy specimens. PSMA-PET is done before ADT and at maximum SUV defined by the phase A.

Sponsor

Turku University Hospital

Phase

N/A

Contacts

Jukka Kemppainen, MD, PhD (CONTACT)

jukka.kemppainen@tyks.fi

+358-2-3130196

Otto Ettala, MD, PhD (CONTACT)

otto.ettala@tyks.fi

+358-2-3130280

ClinicalTrials.gov

NCT03313726

Drug / Compound

PSMA-11

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

Eligibility

Inclusion

  • Clinical stage: T1c-T4N0-2M0-1 (arm, A); T1c-T3NxMx (arm, B)
  • Adequate histological sampling consisting of at least 3 biopsy samples from each lobe
  • Diagnosis: Histologically confirmed adenocarcinoma of prostate
  • No previous surgical, radiation or endocrine treatment for prostate carcinoma
  • Language spoken: Finnish
  • Patient agrees to undergo surgery (arm, B)

Exclusion

  • Prior usage of 5-ARI medication in past 12 months
  • Patient preference for active surveillance as a method of prostate cancer management