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

NCT ID: NCT04462926

Last Updated: 2020-09-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-20
• Study Completion Date: 2024-09-20

Brief Summary

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).

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).

Conditions

Prostate Cancer; Prostatic Neoplasm; Urogenital Neoplasms; Prostatic Disease; Disease Attributes; Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

[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

Group Type: EXPERIMENTAL

[68Ga]Ga-PSMA-11 PET/CT

Intervention Type: DIAGNOSTIC_TEST

1.8-2.2 MBq (0.049-0.060 mCi) per kilogram bodyweight will be injected intravenously prior to perform the PET/CT

Interventions

[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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliero-Universitaria di Modena

OTHER

Sponsor Role: lead

Responsible Party

Antonella Franceschetto

Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Azienda Ospedaliero-Universitaria di Modena

Modena, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Pietro Ghedini, MD

Role: CONTACT

ghedini.pietro@aou.mo.it

0594225167

Facility Contacts

Pietro Ghedini, MD

Role: primary

ghedini.pietro@aou.mo.it

0594225167

Other Identifiers

2019-004685-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ND

Identifier Type: -

Identifier Source: org_study_id