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

Sponsor

University Hospital, Bordeaux (Other)

Overall Status

Recruiting

CT.gov ID

NCT03606837

Collaborator

(none)

Enrollment

Location

Arm

43.3

Anticipated Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Drug: 68Ga-PSMA-617 PET/CT Drug: 68Ga-RM2 PET/CT	Phase 2

Detailed Description

European Association of Urology (EAU) Guidelines for initial staging of intermediate risk prostate cancer (Gleason score 3+4 and 4+3) include tomodensitometry (CT scan), magnetic resonance imaging (MRI) and bone scintigraphy. However, this group of tumor is highly heterogeneous. A distinction exist between tumors with Gleason score 3+4 (lower risk) and 4+3 which may be closer to high risk prostate cancer.

Consequently, management of these two sub-groups of tumors differs. The key point for optimal management of these tumors is to get specific and non-invasive molecular tools for better classification and stratification. This is of critical importance for personalized treatment decision-making.

Novel innovative radiotracers are today available for prostate cancer imaging notably small molecules, radiolabeled with 68Ga, targeting the prostate specific membrane antigen (PSMA) or antagonists, radiolabeled with 68Ga, targeting the Gastrin-Releasing Peptide receptor (GRP-R, a bombesin receptor subtype).

There are on growing evidences that Positron Emission Tomography coupled to Computed Tomography (PET-CT) with radiolabeled prostate specific membrane antigen analogues (PSMA) could be more sensitive and more specific for the detection of lymph node metastasis in high-risk cancers, as shown with PSMA-617 in recent studies.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Exploratory, Single-institution Study, Comparing 68Ga-RM2 PET/CT Versus 68Ga-PSMA-617 PET/CT in Patients Diagnosed With Intermediate Risk Prostate Cancer Candidates for Radical Prostatectomy

Actual Study Start Date :

Jul 11, 2019

Anticipated Primary Completion Date :

Feb 17, 2023

Anticipated Study Completion Date :

Feb 17, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PET/CT Imaging	Drug: 68Ga-PSMA-617 PET/CT PET/CT Imaging with 68Ga-PSMA-617 injection Drug: 68Ga-RM2 PET/CT PET/CT Imaging with 68Ga-RM2 injection

Arm

Intervention/Treatment

Experimental: PET/CT Imaging

Drug: 68Ga-PSMA-617 PET/CT

PET/CT Imaging with 68Ga-PSMA-617 injection

Drug: 68Ga-RM2 PET/CT

PET/CT Imaging with 68Ga-RM2 injection

Outcome Measures

Primary Outcome Measures

Median Standardized Uptake Value (SUV) [Day 0 (inclusion) or Day 2 to 21 (Visit 2)]
Uptake intensity of 68Ga-PSMA-617

Secondary Outcome Measures

Gleason score [Day 3 to 60 (Last visit)]
Receptor density Bmax [Day 0 (inclusion) or Day 2 to 21 (Visit 2)]
Local radioactive concentration (cpm) [Day 0 (inclusion) or Day 2 to 21 (Visit 2)]
Immunoreactive score (IRS) [Day 3 to 60 (Last visit)]
New World Health Organization 2016 classification [Day 3 to 60 (Last visit)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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 ……