Study on patients with prostate cancer with the PET/MR

Phase II monocentric study to evaluate a novel approach for staging prostate cancer patients by using a fully integrated hybrid PET/MRI - PETMR-Staging-PCa1

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-001034-18-IT

Enrollment

Registered

2018-11-05

Start date

2020-03-04

Completion date

Unknown

Last updated

2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient diagnosed with prostatic carcinoma MedDRA version: 21.1 Level: LLT Classification code 10026389 Term: Malignant neoplasm of prostate System Organ Class: 100000004864

Interventions

Product Name: 68GA-PSMA-HBED-CC Product Code: [68GA-PSMA-HBED-CC] Pharmaceutical Form: Solution for injection INN or Proposed INN: PSMA-HBED-CC (PSMA-11) Current Sponsor code: 68Ga-PSMA Other descript

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Age = 18 years 2. Diagnosis of prostate cancer proven by biopsy 3. Informed informed consent 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 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25

Exclusion criteria

Exclusion criteria: 1. Age less than 18 years 2. Inability to complete required imaging tests (eg severe claustrophobia) 3. Any other medical condition that may interfere with study compliance 4. All contraindications for MRI (eg pace-maker) 5. Evidence of metastatic disease to conventional imaging that would contraindicate the surgical procedure

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluate a new diagnostic and innovative approach for the staging of prostate cancer with the use of the recently introduced PET/MR imaging method and new tracers (68Ga-PSMA and 68Ga-Bombesina).;Secondary Objective: - Optimize the image acquisition and analysis protocol of the innovative PET/MR methodology in order to offer an optimal approach. - Characterize the phenotype of the prostatic primary tumor using: 1) hybrid PET/MR imaging with 68Ga-PSMA and 68Ga-Bombesin tracers, 2) multiparametric MRI (mp-MR) techniques; and 3) integrated radiomal analysis with clinical, histopathological and cellular markers of tumor aggression based on peripheral blood particle counts and biochemical, clinical and instrumental follow-up. - Evaluate the stability / reproducibility of the radiomic analysis on mp-MR data for the characterization of the tumor by a testretest procedure. - Define the diagnostic accuracy of PET/MR with 68Ga-PSMA and 68Ga-Bombesina and with state-of-the-art mp-MR staging techniques (T, N and M). - Evaluate the impact of PET/MR with 68Ga-PSMA and 68Ga-Bombesina in the choice of therapeutic strategies and clinical management of the patient.;Primary end point(s): Evaluation of the staging of patients with prostate cancer using PET / MR hybrid imaging with innovative radiopharmaceuticals (68Ga-PSMA and 68Ga-Bombesina) and tumor biomarkers.;Timepoint(s) of evaluation of this end point: 60 months	—

Measure

Time frame

Main Objective: Evaluate a new diagnostic and innovative approach for the staging of prostate cancer with the use of the recently introduced PET/MR imaging method and new tracers (68Ga-PSMA and 68Ga-Bombesina).;Secondary Objective: - Optimize the image acquisition and analysis protocol of the innovative PET/MR methodology in order to offer an optimal approach. - Characterize the phenotype of the prostatic primary tumor using: 1) hybrid PET/MR imaging with 68Ga-PSMA and 68Ga-Bombesin tracers, 2) multiparametric MRI (mp-MR) techniques; and 3) integrated radiomal analysis with clinical, histopathological and cellular markers of tumor aggression based on peripheral blood particle counts and biochemical, clinical and instrumental follow-up. - Evaluate the stability / reproducibility of the radiomic analysis on mp-MR data for the characterization of the tumor by a testretest procedure. - Define the diagnostic accuracy of PET/MR with 68Ga-PSMA and 68Ga-Bombesina and with state-of-the-art mp-MR staging techniques (T, N and M). - Evaluate the impact of PET/MR with 68Ga-PSMA and 68Ga-Bombesina in the choice of therapeutic strategies and clinical management of the patient.;Primary end point(s): Evaluation of the staging of patients with prostate cancer using PET / MR hybrid imaging with innovative radiopharmaceuticals (68Ga-PSMA and 68Ga-Bombesina) and tumor biomarkers.;Timepoint(s) of evaluation of this end point: 60 months

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Secondary

Measure	Time frame
Secondary end point(s): - Optimization of the PET/MR acquisition protocol with 68Ga-PSMA and 68Ga-Bombesina for the staging of the patient with prostate tumor.; Characterization of the tumor phenotype with imaging and histopathological data.; - Definition of the stability/reproducibility of the radiomic analysis.; - Evaluation of the diagnostic accuracy of PET/MR with 68Ga-PSMA and 68Ga-Bombesina.;Timepoint(s) of evaluation of this end point: 60 months; 60 months; 60 months; 60 months	—

Measure

Time frame

Secondary end point(s): - Optimization of the PET/MR acquisition protocol with 68Ga-PSMA and 68Ga-Bombesina for the staging of the patient with prostate tumor.; Characterization of the tumor phenotype with imaging and histopathological data.; - Definition of the stability/reproducibility of the radiomic analysis.; - Evaluation of the diagnostic accuracy of PET/MR with 68Ga-PSMA and 68Ga-Bombesina.;Timepoint(s) of evaluation of this end point: 60 months; 60 months; 60 months; 60 months

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Countries

Italy

Contacts

Public ContactMedicina Nucleare

IRCCS Ospedale San Raffaele

incerti.elena@hsr.it0226432717

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 12, 2026