NCT03604757

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for phase_2 prostate-cancer

Timeline
Completed

Started Apr 2018

Shorter than P25 for phase_2 prostate-cancer

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

Study Start

First participant enrolled

April 25, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 27, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2019

Completed
Last Updated

May 14, 2026

Status Verified

June 1, 2020

Enrollment Period

1.7 years

First QC Date

July 19, 2018

Last Update Submit

May 11, 2026

Conditions

Prostate Cancer

Keywords

Prostate Cancer68Ga-RM2bombesinGRP-R68Ga-Prostate Specific Membrane AntigenPSMAPET/CT

Outcome Measures

Primary Outcomes (2)

  • Median Standardized Uptake Value (SUV)

    Median Standardized Uptake Value (SUV) of 68Ga-PSMA-617

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

  • Median Standardized Uptake Value (SUV)

    Median Standardized Uptake Value (SUV) of 68Ga-RM2

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

Secondary Outcomes (4)

  • 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)

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 low risk prostate cancer (Gleason score ≤ 6 and cT1-T2a and Prostate Specific Antigen (PSA) value \< 10 ng/mL)
  • 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)
  • 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

You may not qualify if:

  • 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
  • known contraindication to radiopharmaceuticals and / or excipients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bordeaux University Hospital

Bordeaux, 33076, France

Location

Related Publications (2)

  • Schollhammer R, Robert G, Asselineau J, Yacoub M, Vimont D, Balamoutoff N, Bladou F, Benard A, Hindie E, Gallerande HC, Morgat C. Comparison of 68Ga-PSMA-617 PET/CT and 68Ga-RM2 PET/CT in Patients with Localized Prostate Cancer Who Are Candidates for Radical Prostatectomy: A Prospective, Single-Arm, Single-Center, Phase II Study. J Nucl Med. 2023 Mar;64(3):379-385. doi: 10.2967/jnumed.122.263889. Epub 2022 Sep 2.

    PMID: 36215569RESULT

  • Schollhammer R, Quintyn Ranty ML, de Clermont Gallerande H, Cavelier F, Valverde IE, Vimont D, Hindie E, Morgat C. Theranostics of Primary Prostate Cancer: Beyond PSMA and GRP-R. Cancers (Basel). 2023 Apr 18;15(8):2345. doi: 10.3390/cancers15082345.

    PMID: 37190273RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • CLERMONT-GALLERANDE Henri

    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 19, 2018

First Posted

July 27, 2018

Study Start

April 25, 2018

Primary Completion

December 19, 2019

Study Completion

December 19, 2019

Last Updated

May 14, 2026

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)