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
Primary Purpose
Prostate Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
F18-PSMA
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
- 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).
- . 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:
- Patients with another malignant disease.
- Patients under the age of 18 years.
Sites / Locations
- Tel Aviv Sourasky medial center, Tel Aviv, Israel
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Prostate cancer patients
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04159090
First Posted
October 29, 2019
Last Updated
November 7, 2019
Sponsor
Tel-Aviv Sourasky Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04159090
Brief Title
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
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 15, 2018 (Actual)
Primary Completion Date
February 15, 2018 (Actual)
Study Completion Date
January 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prostate cancer patients
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
F18-PSMA
Intervention Description
Patients with moderate or high risk of prostate cancer
Primary Outcome Measure Information:
Title
Patients who preformed 68Ga-PSMA-11 Biodistribution Standard to 18F-PSMA-1007 for prostate cancer.
Description
The investigators will report the number of patients that preformed 68Ga-PSMA-11 Biodistribution Standard to 18F-PSMA-1007.
Time Frame
1 year
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Prostate cancer can be only in males
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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).
. 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:
Patients with another malignant disease.
Patients under the age of 18 years.
Facility Information:
Facility Name
Tel Aviv Sourasky medial center, Tel Aviv, Israel
City
Tel Aviv
State/Province
Hamerkaz
ZIP/Postal Code
6436110
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
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
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