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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04116086
• Other study ID #: SHEBA-19-6243-TD-CTIL
• Status: Recruiting
• Phase: N/A
• Start date: September 11, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: October 2019
• Source: Sheba Medical Center
• Contact: Tima Davidson, Dr.
• Phone: 972-52-6666677
• Email: Tima.Davidson[@]sheba.health.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 75 Years

Eligibility

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

-

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Diagnostic Test:
• Prostate Biopsy Test
see earlier information

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prostate Cancer Diagnosis	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.	2 months