Image-Guided (68Ga-PSMA-11 PET/CT) Prostate Biopsy for the Diagnosis of Prostate Cancer in Men With Prior Negative/Inconclusive Biopsy
NCT ID: NCT05160597
Last Updated: 2025-09-25
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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ACTIVE_NOT_RECRUITING
EARLY_PHASE1
30 participants
INTERVENTIONAL
2022-01-13
2027-01-07
Brief Summary
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Detailed Description
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I. To assess the detection rate of clinically significant prostate cancer (Gleason score 7 or more) in patients with focal gallium Ga 68 gozetotide (68Ga-PSMA-11) uptake within the prostate.
OUTLINE:
SCREENING PROCEDURE: Patients receive 68Ga-PSMA-11 intravenously (IV) and 50-100 minutes later, undergo a PET/CT scan. Only patients with 68Ga-PSMA-11 uptake within the prostate proceed to image-guided biopsy.
IMAGE-GUIDED BIOPSY: Patients undergo experimental image-guided prostate biopsy using PET/CT images obtained during screening procedure during a standard of care transrectal ultrasonography guided biopsy (TRUS).
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Diagnostic (68Ga-PSMA-11, image-guided prostate biopsy)
SCREENING PROCEDURE: Patients receive 68Ga-PSMA-11 IV and 50-100 minutes later, undergo a PET/CT scan. Only patients with 68Ga-PSMA-11 uptake within the prostate proceed to image-guided biopsy.
IMAGE-GUIDED BIOPSY: Patients undergo experimental image-guided prostate biopsy using PET/CT images obtained during screening procedure during a standard of care TRUS.
Biopsy of Prostate
Undergo image-guided prostate biopsy
Gallium Ga 68 Gozetotide
Given IV
Transrectal Ultrasonography Guided Biopsy
Undergo standard of care TRUS
Interventions
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Biopsy of Prostate
Undergo image-guided prostate biopsy
Gallium Ga 68 Gozetotide
Given IV
Transrectal Ultrasonography Guided Biopsy
Undergo standard of care TRUS
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Scheduled for a repeat transrectal ultrasound (TRUS) prostate biopsy by standard of care
* Focal 68Ga-PSMA-11 uptake within the prostate
Exclusion Criteria
* Age \< 18 and \> 90 years
* Recurrent prostate cancer
* Inability to provide written informed consent
* Known inability to remain still and lie flat for the duration of the PET/CT (about 30 minutes)
18 Years
90 Years
MALE
No
Sponsors
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Jonsson Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Jeremie Calais
Role: PRINCIPAL_INVESTIGATOR
UCLA / Jonsson Comprehensive Cancer Center
Locations
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UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States
Countries
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Other Identifiers
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NCI-2021-12975
Identifier Type: REGISTRY
Identifier Source: secondary_id
21-001122
Identifier Type: -
Identifier Source: org_study_id
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