TheranosticTrials.org

Clinical Trial · NCT03604757

68Ga-RM2 Compared to 68Ga-PSMA-617 PET/CT for Prostate Cancer Imaging According to Various Metastatic Risks

Overview

Patients with primary prostate cancer (low, intermediate or high metastatic risk) for whom radical prostatectomy is indicated, will be invited to participate to the present study. Positron Emission Tomography coupled with scanner (PET-CT) using a radiotracer : 68Ga-RM2 and Positron Emission Tomography coupled with scanner (PET-CT) using another radiotracer : 68Ga-PSMA-617, will be scheduled.

Sponsor

University Hospital, Bordeaux

Phase

Phase 2

Contacts

CLERMONT-GALLERANDE Henri (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT03604757

Drug / Compound

RM2

Isotope(s):
Target(s):
  • GRPR
Ligand Class: Peptides
Chelator: DOTA

PSMA-617

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

PSMA-11

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

Eligibility

Inclusion

  • Candidate for radical prostatectomy after discussion in multidisciplinary committee
  • 6 patients with low risk prostate cancer (Gleason score ≤ 6 and cT1-T2a and Prostate Specific Antigen (PSA) value \< 10 ng/mL)
  • any kind of previous treatment for prostate cancer (hormonal treatment, EBRT, brachytherapy, cryotherapy, etc…);
  • 6 patients with high risk prostate cancer (Gleason \> 7 or cT2c or PSA value \> 20 ng/mL)
  • 12 patients with intermediate risk prostate cancer (Gleason score 7 or cT2b or PSA value 10-20 ng/mL) divided in : 6 patients who are Gleason score 7(3+4) (favourable intermediate risk) 6 patients who are Gleason score 7(4+3) (unfavourable intermediate risk)
  • patient not candidate for radical prostatectomy and/or unable to benefit from surgery

Exclusion

Exclusion criteria not yet provided.