Head- to Head Comparison of [68Ga]Ga-PSMA-11 With [18F]PSMA-1007 PET/CT in Staging Prostate Cancer Using Histopathology and Immunohistochemical Analysis as Reference-Standard

PSMA (Prostate Specific Membrane Antigen) is overexpressed in prostate cancer cells.

The 68Ga-PSMA PET / CT test, using small molecules that bind to the PSMA protein and undergo intercellularization, is a test that has been shown to be more sensitive and specific than other conventional and molecular imaging modalities (CT, MRI, bone mapping, Disease in prostate cancer patients and its consequences often change therapeutic decisions in patients. In light of this, the examination of the health basket of the State of Israel was introduced to the staging of patients at moderate or high risk, as well as to the extent of the disease in patients with biochemical failure.

However, testing with 68Ga-PSMA has several limitations, resulting from the use of 68 Ga, which can be overcome by switching to fluorine-18 (18F) -based materials:

A. The generation capacity of the generator is low and therefore limits the number of tests that can be performed at a given time. In contrast, 18F is produced in cyclotron.

B. 68 Ga has a short half-life of 68 minutes, which is a logical consequence of its availability to remote medical centers from the place of production, the time of the test and the patient's comfort, and the possibility of subsequent mappings. The half-life of 18F is 110 minutes.

third. 18F has less energy than 68Ga (0.65 MEV vs. 1.9) and, as a result, a better maximum resolution that would potentially enable the demonstration of smaller lymph nodes involved in the disease.

Among the fluorine-18 (18F) materials selected for clinical application is 18F-PSMA-1007, both because the uptake is higher in the tumor than in the background, and because its removal is mainly the pathobiliary and only a small fraction of the material is released in the urine. This is another advantage of 18F-PSMA-1007 over 68Ga-PSMA, potentially enabling a better demonstration of disease sites in the pelvis, without significant absorption of the bladder material.

To date, accumulated promising experience, in Germany, in imaging with 18F-PSMA-1007. In one published case, 17 degenerative disease sites were detected in one patient with biochemical failure 9 years after undergoing radical prostatectomy, which was not demonstrated by other imaging modalities, including CT, MRI and bone mapping

Study Overview

• Status: Unknown
• Conditions: Prostate Cancer
• Intervention / Treatment: Diagnostic test: F18-PSMA

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Hamerkaz
    • Tel Aviv, Hamerkaz, Israel, 6436110
      • Tel Aviv Sourasky medial center, Tel Aviv, Israel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Patients with prostate cancer, at moderate or high risk according to D'Amico classification during the staging phase,and who have not received any treatment (Gleason 7 and above and / or PSA> 10 and / or T2c or greater disease stage).
2. . Patients who are treated in the Department of Urology at Tel Aviv Medical Center and who are undergoing Radical Prostatectomy, as a Dependent Treatment.

Exclusion Criteria:

1. Patients with another malignant disease.
2. Patients under the age of 18 years.

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: Prostate cancer patients	Diagnostic test: F18-PSMA; Patients with moderate or high risk of prostate cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients who preformed 68Ga-PSMA-11 Biodistribution Standard to 18F-PSMA-1007 for prostate cancer.	The investigators will report the number of patients that preformed 68Ga-PSMA-11 Biodistribution Standard to 18F-PSMA-1007.	1 year

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2018
• Primary Completion (Actual): February 15, 2018
• Study Completion (Anticipated): January 1, 2020

Study Registration Dates

• First Submitted: October 29, 2019
• First Submitted That Met QC Criteria: November 7, 2019
• First Posted (Actual): November 12, 2019

Study Record Updates

• Last Update Posted (Actual): November 12, 2019
• Last Update Submitted That Met QC Criteria: November 7, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: TASMC-17-ES-0765-CTIL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No