NCT03606837

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_2 prostate-cancer

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 31, 2018

Completed
12 months until next milestone

Study Start

First participant enrolled

July 11, 2019

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2023

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 11, 2023

Completed
Last Updated

May 19, 2026

Status Verified

July 1, 2025

Enrollment Period

3.9 years

First QC Date

July 20, 2018

Last Update Submit

May 18, 2026

Conditions

Prostate Cancer

Keywords

Prostate Cancer68Ga-RM268Ga-Prostate Specific Membrane AntigenPET/CTProstate cancer imaging

Outcome Measures

Primary Outcomes (1)

  • Median Standardized Uptake Value (SUV)

    Uptake intensity of 68Ga-PSMA-617

    Day 0 (inclusion) or Day 2 to 21 (Visit 2)

Secondary Outcomes (5)

  • 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)

Study Arms (1)

PET/CT Imaging

EXPERIMENTAL
Drug: 68Ga-PSMA-617 PET/CTDrug: 68Ga-RM2 PET/CT

Interventions

68Ga-PSMA-617 PET/CTDRUG

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

PET/CT Imaging
68Ga-RM2 PET/CTDRUG

PET/CT Imaging with 68Ga-RM2 injection

PET/CT Imaging

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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 ……

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bordeaux University Hospital

Bordeaux, 33079, France

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Henri CLERMONT-GALLERANDE

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2018

First Posted

July 31, 2018

Study Start

July 11, 2019

Primary Completion

June 15, 2023

Study Completion

July 11, 2023

Last Updated

May 19, 2026

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)