Using PSMA PET-CT as a Diagnostic Tool for Detection of Prostatic Cancer at an Early Stage
NCT ID: NCT04116086
Last Updated: 2019-10-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2019-09-11
2020-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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PSMA PET-CT exam
Ga 68 -PSMA PET/CT scanning will be performed using a combined PET/CT protocol with a 16-detector-row helical CT scanner (Philips Gemini GXL). This scanner allows simultaneous acquisition of up to 45 transaxial PET images with interslice spacing of 5 mm in one bed position and provides an image from the vertex to the thigh in about 10 bed positions. The use of (68)Ga-PSMA HBED-CC results in a relatively low radiation exposure, delivering organ doses that are comparable to those of other (68)Ga-labelled PSMA-inhibitors used for PET-imaging. Total effective dose is lower than for other PET-agents used for prostate cancer imaging (e.g. (11) C- and (18) F-Choline).
Prostate Biopsy Test
see earlier information
Interventions
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Prostate Biopsy Test
see earlier information
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
6. Underwent previous prostate biopsy
7. Previous radiation to pelvis for any reason
\-
40 Years
75 Years
MALE
No
Sponsors
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Sheba Medical Center
OTHER_GOV
Responsible Party
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Dr. Tima Davidson
Head of the Hybrid Imaging Unit
Locations
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Sheba Medical Center
Ramat Gan, , Israel
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SHEBA-19-6243-TD-CTIL
Identifier Type: -
Identifier Source: org_study_id
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