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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 : January 11, 2023
Sponsor:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Tracking Information
First Submitted Date  ICMJE December 15, 2021
First Posted Date  ICMJE December 16, 2021
Last Update Posted Date January 11, 2023
Actual Study Start Date  ICMJE January 13, 2022
Estimated Primary Completion Date January 7, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 15, 2021)		 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Image-Guided (68Ga-PSMA-11 PET/CT) Prostate Biopsy for the Diagnosis of Prostate Cancer in Men With Prior Negative/Inconclusive Biopsy
Official Title  ICMJE 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
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.
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Prostate Carcinoma
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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.

Interventions:
  • Procedure: Biopsy of Prostate
  • Other: Gallium Ga 68 Gozetotide
  • Procedure: Transrectal Ultrasonography Guided Biopsy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 15, 2021)		 30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 7, 2025
Estimated Primary Completion Date January 7, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Wesley Armstrong 310-206-1146 warmstrong@mednet.ucla.edu
Contact: Stephanie Lira 310-206-0596 StephanieLira@mednet.ucla.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05160597
Other Study ID Numbers  ICMJE 21-001122
NCI-2021-12975 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Jonsson Comprehensive Cancer Center
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Jonsson Comprehensive Cancer Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jeremie Calais UCLA / Jonsson Comprehensive Cancer Center
PRS Account Jonsson Comprehensive Cancer Center
Verification Date January 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP