Evaluation of Diagnostic Accuracy of [68Ga]Ga-PSMA-11 PET/CT in Primary Staging of Intermediate and High Risk Prostatic Cancer in Men Newly Diagnosed (PSMA-PROSTAPET)

This is a diagnostic accuracy prospective, single-centre, open-label, single group assignment interventional study.

Its aim is to evaluate the diagnostic accuracy of [68Ga]Ga-PSMA-11 PET/CT in detection of primary tumour and extra prostatic disease (lymph node, soft tissues spread or bone metastases) in men newly diagnosed with Prostate Cancer at Intermediate and High Risk, according to 2019 Prostate Cancer EAU Guidelines Risk Group Stratification (see Study Population paragraph).

The investigators are interested in the possible future role of [68Ga]Ga-labelled PSMA PET/CT as integration to conventional imaging mpMRI (with or without CT of the lower abdomen and Bone scan) in the detection of primary tumor and extra-prostatic disease (lymph node and soft tissues spread or bone metastases).

Study Overview

• Status: Recruiting
• Conditions: Neoplasms; Urogenital Neoplasms; Disease Attributes; Prostate Cancer; Prostatic Neoplasm; Prostatic Disease
• Intervention / Treatment: Diagnostic test: [68Ga]Ga-PSMA-11 PET/CT

Detailed Description

This is a diagnostic accuracy prospective, single-centre, open-label, single group assignment interventional study.

The primary objective of this study is to evaluate the diagnostic accuracy of [68Ga]Ga-PSMA-11 PET/CT in detection of primary tumor and extraprostatic disease (lymph node, soft tissues spread or bone metastases) in men newly diagnosed with prostate cancer at intermediate or high-risk.

The secondary objective of this study is to compare the diagnostic accuracy of [68Ga]Ga-PSMA-11 PET/CT to the diagnostic accuracy of conventional imaging mpMRI (with or without CT of the lower abdomen and Bone scan) in the prostatic bed and extra prostatic disease in men newly diagnosed with prostate cancer at intermediate or high-risk.

To evaluate association between [68Ga]Ga-PSMA-11 PET/CT uptake value (SUVmax and SUVmean) and aggressiveness of prostate tumor (e.g. PSA serum level and Gleason Score).

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pietro Ghedini, MD; Phone Number: 0594225167; Email: ghedini.pietro@aou.mo.it

Study Locations

• Italy
  • Modena, Italy, 41124
    • Recruiting
    • Azienda Ospedaliero-Universitaria di Modena
    • Contact: Pietro Ghedini, MD; Phone Number: 0594225167; Email: ghedini.pietro@aou.mo.it
    • Principal Investigator: Antonella Franceschetto, MD
    • Sub-Investigator: Pietro Ghedini, MD
    • Sub-Investigator: Antonella Iudicello, Pharm D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

I. Patients with histo-pathological confirmation of PCa with intermediate or high-risk disease according to 2019 Prostate Cancer EAU Guidelines Risk Group Stratification (see Study Population paragraph)

II. Patients with conventional imaging mpMRI (with or without CT of the lower abdomen and Bone scan) performed as baseline in primary PCa staging according to 2019 Prostate Cancer EAU Guidelines

III. Age >18 years/old

IV. Ability to provide written informed consent

Exclusion Criteria:

I. Contra-indication for PET/CT scan: Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam

II. Impaired renal function

III. Impaired liver function: AST or ALT > 2.5 x ULN

IV. Patients unable to understand the purpose of the study

V. Medical history of allergic reactions or hypersensitivity to [68Ga] Ga-PSMA-11 as well as to any excipient or component of the experimental medicinal product

VI. Having partecipated in clinical trial in which the experimental intervention was administered within 30 days (or 5 half-life) from administration the endovenous solution of [68Ga]Ga-PSMA-11

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: [68Ga]Ga-PSMA-11 PET/CT; 1.8-2.2 MBq (0.049-0.060 mCi) per kilogram bodyweight will be injected intravenously prior to perform the PET/CT	Diagnostic test: [68Ga]Ga-PSMA-11 PET/CT; 1.8-2.2 MBq (0.049-0.060 mCi) per kilogram bodyweight will be injected intravenously prior to perform the PET/CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic accuracy measures (sensitivity, specificity, positive and negative predictive values) of [68Ga]Ga-PSMA-11 PET/CT in detection of primary tumor and extraprostatic disease (lymph node, soft tissues spread or bone metastases).	For the primary objective, the following index test and reference test will be considered: Index test: [68Ga]Ga-PSMA-11 PET/CT performed before treatment. Reference test: clinical, radiological and histo-pathologic assessment, when available, at 12 months followup and up to 24 months after treatment. Two nuclear medicine physicians will review the PET images using PET/CT Software Syngo.via. A PET positive finding for pelvic or retroperitoneal lymph nodes or lymph nodes ≥ 8mm is defined with PSMA uptake equal to or above blood pool and lower than liver. A PET positive finding in lymph nodes of other regions is defined with PSMA uptake equal to or above liver and lower than parotid gland. Any uptake equal to or above parotid gland will be considered positive. The readers will be blinded to clinical and pathologic data, except for the knowledge of diagnosis of biopsy proven prostate cancer.	Up to 24 months after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparation diagnostic accuracy of the [68Ga]Ga-PSMA-11 PET/CT versus the conventional imaging mpMRI (with or without CT of the lower abdomen and Bone scan) in the prostatic bed and extra prostatic disease.	For the secondary objective, the following index test and reference test will be considered: Index test: conventional imaging mpMRI performed before treatment. Reference test: clinical, radiological and histo-pathologic assessment at 12 months follow-up and up to 24 months after treatment. MRI imaging results will be evaluated by two radiologists specializing in body MRI imaging with the PI-RADS version 2 criteria. In addition, for the secondary objective, after testing the assumption of normality with the Kolmogorov-Smirnov test, the metabolic PET parameters (SUV max and SUV mean) will be correlated with PSA serum level, by using the Pearson correlation, and with Gleason score and tumor volume, by using the Spearman correlation.	Up to 24 months after treatment

Collaborators and Investigators

• Sponsor: Azienda Ospedaliero-Universitaria di Modena

Study record dates

Study Major Dates

• Study Start (Anticipated): September 20, 2020
• Primary Completion (Anticipated): September 20, 2024
• Study Completion (Anticipated): September 20, 2024

Study Registration Dates

• First Submitted: June 26, 2020
• First Submitted That Met QC Criteria: July 6, 2020
• First Posted (Actual): July 8, 2020

Study Record Updates

• Last Update Posted (Actual): September 17, 2020
• Last Update Submitted That Met QC Criteria: September 16, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Prostate cancer; 68GaPSMA PET/CT; primary staging
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Genital Neoplasms, Male; Neoplasms; Prostatic Neoplasms; Urogenital Neoplasms; Prostatic Diseases; Disease Attributes; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Gallium 68 PSMA-11
• Other Study ID Numbers: ND; 2019-004685-18 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No