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

NCT04462926 | Unknown

• 2 other identifiers: ND2019-004685-18
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

68GaPSMA PET/CT; Prostate cancer; primary staging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

  Up to 24 months after treatment

Study Arms (1)

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

EXPERIMENTAL

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

Interventions

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria di Modena: lead

Study Sites (1)

Azienda Ospedaliero-Universitaria di Modena

Modena, 41124, Italy

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Urogenital Neoplasms; Prostatic Diseases; Disease Attributes; Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Pietro Ghedini, MD

CONTACT

0594225167; ghedini.pietro@aou.mo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: June 26, 2020
• First Posted: July 8, 2020
• Study Start: September 20, 2020
• Primary Completion: September 20, 2024
• Study Completion: September 20, 2024
• Last Updated: September 17, 2020

Record last verified: 2020-09

Locations

IT (1)