Image-Guided (68Ga-PSMA-11 PET/CT) Prostate Biopsy for the Diagnosis of Prostate Cancer in Men With Prior Negative/Inconclusive Biopsy
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| ClinicalTrials.gov Identifier: NCT05160597 |
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Recruitment Status :
Recruiting
First Posted : December 16, 2021
Last Update Posted : February 17, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Prostate Carcinoma | Procedure: Biopsy of Prostate Other: Gallium Ga 68 Gozetotide Procedure: Transrectal Ultrasonography Guided Biopsy | Early Phase 1 |
PRIMARY OBJECTIVE:
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).
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 30 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Diagnostic |
| Official Title: | Evaluation of 68Ga-PSMA-11 PET Guided Prostate Biopsy in Men With Suspicion of Clinically Significant Prostate Cancer and Prior Negative/Inconclusive Biopsy: A Prospective Exploratory Study |
| Actual Study Start Date : | January 13, 2022 |
| Estimated Primary Completion Date : | July 31, 2024 |
| Estimated Study Completion Date : | July 31, 2025 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 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. |
Procedure: Biopsy of Prostate
Undergo image-guided prostate biopsy
Other Names:
Other: Gallium Ga 68 Gozetotide Given IV
Other Names:
Procedure: Transrectal Ultrasonography Guided Biopsy Undergo standard of care TRUS
Other Names:
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- Detection rate of clinically significant prostate cancer [ Time Frame: Up to 3 years ]Defined as the percentage of clinically significant prostate cancer (Gleason score 7 or more) in patients with focal 68Ga-PSMA-11 uptake within the prostate
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| Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Men with suspicion of clinically significant prostate cancer with prior inconclusive, discordant or negative magnetic resonance imaging/ultrasound (MRI/US) fusion prostate biopsy
- Scheduled for a repeat transrectal ultrasound (TRUS) prostate biopsy by standard of care
- Focal 68Ga-PSMA-11 uptake within the prostate
Exclusion Criteria:
- Negative 68Ga-PSMA-11 uptake within the prostate (screening failure)
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05160597
| Contact: Wesley Armstrong | 310-206-1146 | warmstrong@mednet.ucla.edu | |
| Contact: Stephanie Lira | 310-206-0596 | StephanieLira@mednet.ucla.edu |
| United States, California | |
| UCLA / Jonsson Comprehensive Cancer Center | Recruiting |
| Los Angeles, California, United States, 90095 | |
| Contact: Jeremie Calais jcalais@mednet.ucla.edu | |
| Principal Investigator: Jeremie Calais | |
| Principal Investigator: | Jeremie Calais | UCLA / Jonsson Comprehensive Cancer Center |
| Responsible Party: | Jonsson Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT05160597 |
| Other Study ID Numbers: |
21-001122 NCI-2021-12975 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) |
| First Posted: | December 16, 2021 Key Record Dates |
| Last Update Posted: | February 17, 2022 |
| Last Verified: | February 2022 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
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Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Prostatic Diseases Edetic Acid |
Gallium 68 PSMA-11 Chelating Agents Sequestering Agents Molecular Mechanisms of Pharmacological Action Anticoagulants Calcium Chelating Agents Radiopharmaceuticals |