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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
Recruitment Status : Recruiting
First Posted : December 16, 2021
Last Update Posted : February 17, 2022
Sponsor:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Brief Summary:
This early phase I trial studies how well an image-guided prostate biopsy using the imaging agent 68Ga-prostate-specific membrane antigen (PSMA)-11 with a positron emission tomography/computed tomography (PET/CT) scan works in diagnosing prostate cancer in men with a prior negative or inconclusive prostate biopsy. PSMA is a protein that is found on the surface of prostate cancer cells. 68Ga-PSMA-11 is made up of a substance that binds to PSMA on tumor cells, linked with a radioactive substance that can then be seen on imaging scans such as PET/CT. 68Ga-PSMA-11 PET/CT-guided biopsy may help improve the detection rate of prostate cancer. This may help reduce over-diagnosis and over-treatment in men with low-risk prostate cancer and under-treatment in men with high-risk prostate cancer.

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

Detailed Description:

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).

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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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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:
  • Prostate Biopsy
  • Prostatic Biopsy

Other: Gallium Ga 68 Gozetotide
Given IV
Other Names:
  • (68)Ga labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC
  • (68)Ga-labeled Glu-urea-Lys(Ahx)-HBED-CC
  • (68)Ga-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC
  • (68)Gallium-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC
  • (68Ga)Glu-urea-Lys(Ahx)-HBED-CC
  • 68Ga-DKFZ-PSMA-11
  • 68Ga-HBED-CC-PSMA
  • 68Ga-labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC
  • 68Ga-PSMA
  • 68Ga-PSMA-11
  • 68Ga-PSMA-HBED-CC
  • [68Ga] Prostate-specific Membrane Antigen 11
  • [68Ga]GaPSMA-11
  • Ga PSMA
  • Ga-68 labeled DKFZ-PSMA-11
  • Ga-68 labeled PSMA-11
  • GA-68 PSMA-11
  • Gallium Ga 68 PSMA-11
  • Gallium Ga 68-labeled PSMA-11
  • GALLIUM GA-68 GOZETOTIDE
  • Gallium-68 PSMA
  • Gallium-68 PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC
  • GaPSMA
  • PSMA-HBED-CC GA-68

Procedure: Transrectal Ultrasonography Guided Biopsy
Undergo standard of care TRUS
Other Names:
  • TRUS Biopsy
  • TRUS-Guided Biopsy




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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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
Criteria

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)

Information from the National Library of Medicine

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


Contacts
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Contact: Wesley Armstrong 310-206-1146 warmstrong@mednet.ucla.edu
Contact: Stephanie Lira 310-206-0596 StephanieLira@mednet.ucla.edu

Locations
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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         
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
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Principal Investigator: Jeremie Calais UCLA / Jonsson Comprehensive Cancer Center
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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

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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
Additional relevant MeSH terms:
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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