68Ga-RM2 Compared to 68Ga-PSMA-617 PET/CT for Intermediate Risk Prostate Cancer Imaging

• Status: Recruiting
• Trial end date: 2020-12-17
• Target enrollment: 0
• Participant gender: Male

Summary

Patients with primary intermediate risk prostate cancer 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Bordeaux
• Treatments: Gallium 68 PSMA-11

Criteria

Inclusion criteria:

15 patients divided in :

• 7 patients with favourable intermediate risk prostate cancer (cT2b or Gleason score 7 (3+4) or PSA value 10-20 ng/mL, Briganti 5-20%,)

• 8 patients with unfavourable intermediate risk prostate cancer (cT2b or Gleason score 7 (4+3) or PSA value 10-20 ng/mL, Briganti 5-20%,)

• who are candidate for radical prostatectomy after discussion in multidisciplinary committee

• covered by the national health insurance system

• with freely written informed consent obtained

Exclusion criteria:

• Any kind of previous treatment for prostate cancer (hormonal treatment, EBRT, brachytherapy, cryotherapy, etc…);

• Patient with prostate cancer not candidate for radical prostatectomy and/or unable to benefit from surgery

• Freedom privated patient

• Patient under legal protection or unable to express its own consent

• Known contraindication to radiopharmaceuticals and / or excipients ……