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Completed

NCT Number: NCT03606837

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Bordeaux University Hospital

Bordeaux, 33079, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 ……

Treatment and study plan

68Ga-PSMA-617 PET/CT

Drug

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

68Ga-RM2 PET/CT

Drug

PET/CT Imaging with 68Ga-RM2 injection

Primary outcomes

  1. Median Standardized Uptake Value (SUV)

    Time frame: Day 0 (inclusion) or Day 2 to 21 (Visit 2)

    Uptake intensity of 68Ga-PSMA-617

Secondary outcomes

  1. Gleason score

    Time frame: Day 3 to 60 (Last visit)

  2. Receptor density Bmax

    Time frame: Day 0 (inclusion) or Day 2 to 21 (Visit 2)

  3. Local radioactive concentration (cpm)

    Time frame: Day 0 (inclusion) or Day 2 to 21 (Visit 2)

  4. Immunoreactive score (IRS)

    Time frame: Day 3 to 60 (Last visit)

  5. New World Health Organization 2016 classification

    Time frame: Day 3 to 60 (Last visit)

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study 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

Acronym: PROSTATEP

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jul 31, 2018
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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