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

• Status: Completed
• Trial end date: 2019-12-19
• Target enrollment: 0
• Participant gender: Male

Summary

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.

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

Details

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

Criteria

Inclusion criteria :

24 patients divided in :

• 6 patients with low risk prostate cancer (Gleason score ≤ 6 and cT1-T2a and Prostate Specific Antigen (PSA) value < 10 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)

• 6 patients with high risk prostate cancer (Gleason > 7 or cT2c or PSA value > 20 ng/mL)

• Candidate for radical prostatectomy after discussion in multidisciplinary committee

• Covered by the national health insurance system

• Written informed consent willingly obtained

Exclusion criteria :

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

• patient not candidate for radical prostatectomy and/or unable to benefit from surgery

• freedom deprivated patient by judiciary or administrative decision

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

• patient within exclusion period from another clinical trial

• known contraindication to radiopharmaceuticals and / or excipients