Using PSMA PET-CT as a Diagnostic Tool for Detection of Prostatic Cancer at an Early Stage

Not Applicable

• Conditions: Prostate Cancer

• Registration Number: NCT04116086
• Lead Sponsor: Sheba Medical Center

Brief Summary

The aim of the study is the evaluation of the possible role of PSMA PET-CT in early detection of prostate cancer, reducing rate of unnecessary prostate biopsies, and in cases of prostate cancer, correct staging of the disease and corresponding management.

Detailed Description

The aim of the study is the evaluation of the possible role of PSMA PET-CT in early detection of prostate cancer, reducing rate of unnecessary prostate biopsies, and in cases of prostate cancer, correct staging of the disease and corresponding management.

Consequently, use of PSMA PET-CT in patients with suspicious PSA changes may improve our knowledge whether the prostate tumor is clinically significant or not (for the development of PSMA PET-CT with 68 Ga ligand allows to visualize prostate cancer with aggressive patterns), and improve clinical decision making for performing prostate biopsy or selecting patients for observation only.

In light of the above, we are of the opinion that this proposed study has the potential to significantly alter the medical practice of how prostate cancer is diagnosed, which even today suffers from real clinical dilemma.

Study Timeline

• Study Start: 2019-09-11
• Study First Submitted: 2019-09-11
• Status Verified: 2019-10
• Study First Submitted QC: 2019-10-02
• Last Update Submitted: 2019-10-02
• Study First Posted: 2019-10-04
• Last Update Posted: 2019-10-04
• Primary Completion: 2019-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 50

Inclusion Criteria

1. Men aged 40-75

2. With or without suspicious DRE,

3. Were referred by their treating physicians for prostate cancer biopsy based on either an elevated PSA result, a suspicious DRE exam, or both

4. 4 < PSA ≤ 10 ng/ml

Exclusion Criteria

5. A previous diagnosis of prostate cancer

6. Underwent previous prostate biopsy

7. Previous radiation to pelvis for any reason

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Prostate Cancer Diagnosis	2 months	One investigator will interpret the PSMA PET-CT and another one will interpret MRI, both in a blinded and independent fashion and before the biopsy. At the end of the study, these 'blind' PSMA PET-CT and MRI reports will be compared to each other and to the actual fusion biopsy results. In the event that a high correlation is found between the diagnostic imaging results to those of the fusion biopsies, it would suggest that PSMA PET-CT could give the option to be performed instead of the need for biopsy in men who present with high levels of PSA and prompt treatment accordingly.

Trial Locations

Locations (1)

Sheba Medical Center; 🇮🇱 Ramat Gan, Israel