Prostate cancer MedDRA version: 20.0 Level: PT Classification code 10060862 Term: Prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10036909 Term: Prostate cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: 68Ga-RM2
Product Code: 68Ga-RM2
Pharmaceutical Form: Solution for injection
Product Name: 68Ga-PSMA-617
Product Code: 68Ga-PSMA-617
Pharmaceutical Form: Solution for injection
Sponsors
CHU de Bordeaux
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Patients prostate cancer Candidate for radical prostatectomy after discussion in multidisciplinary committee Covered by the national health insurance system Written informed consent willingly obtained Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 24 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 24
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To compare 68Ga-PSMA-617 uptakes values between prostatic sextants for which histologic examination reveal a Gleason score 6, those for which histologic examination reveal a Gleason score 7(3+4) (favourable intermediate risk), for which histologic examination reveal a Gleason score 7(4+3) (unfavourable intermediate risk) and those for which histologic examination reveal a Gleason score 8 or more - To compare 68Ga-RM2 uptakes values between prostatic sextants for which histologic examination reveal a Gleason score 6, those for which histologic examination reveal a Gleason score 3+4 (favourable intermediate risk), those for which histologic examination reveal a Gleason score 4+3 (unfavourable intermediate risk) and for which histologic examination reveal a Gleason score 8 or more ;Secondary Objective: • To compare 68Ga-PSMA-617 and 68Ga-RM2-uptakes between prostatic sextants for which histologic examinations reveal a Gleason score 6 • To compare 68Ga-PSMA-617 and 68Ga-RM2-uptakes between prostatic sextants for which histologic examinations reveal a Gleason score 7(3+4) • To compare 68Ga-PSMA-617 and 68Ga-RM2-uptakes between prostatic sextants for which histologic examinations reveal a Gleason score 7(4+3) • To compare 68Ga-PSMA-617 and 68Ga-RM2-uptakes between prostatic sextants for which histologic examinations reveal a Gleason score 8 or more • To evaluate and compare 68Ga-PSMA-617 and 68Ga-RM2-uptakes in metastatic nodes • To estimate the association between 68Ga-PSMA-617 and 68Ga-RM2-uptakes and Gleason score both in vivo and ex vivo • To compare 68Ga-PSMA-617 uptake in healthy and pathological tissues at 1h and 2h after injection • To compare 68Ga-RM2 uptake in healthy and pathological tissues at 1h and 2h after injection • To compare micro-imaging data to immunohistochemistry ;Primary end point(s): Median Standardized Uptake Value (SUV) of 68Ga-PSMA-617 and 68Ga-RM2 ;Timepoint(s) of evaluation of this end point: Inclusion visit (V1) Follow up | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Gleason score - Micro-imaging data : receptor density Bmax and local radioactive concentration expressed in cpm - Ex vivo immunohistochemistry data: Immunoreactive score (IRS) considering both percentage of stained cells and staining intensity. ;Timepoint(s) of evaluation of this end point: Inclusion visit (V1) Follow up visit (V2) Last visit (V3 - Prostatectomy) | — |
Countries
France
Contacts
Public ContactResponsable Etudes Cliniques
CHU de Bordeaux
Outcome results
None listed