NCT05160597

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P50-P75 for early_phase_1

Timeline
8mo left

Started Jan 2022

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Jan 2022Jan 2027

First Submitted

Initial submission to the registry

December 15, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 16, 2021

Completed
28 days until next milestone

Study Start

First participant enrolled

January 13, 2022

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2025

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2027

Expected
Last Updated

February 12, 2026

Status Verified

September 1, 2025

Enrollment Period

3.5 years

First QC Date

December 15, 2021

Last Update Submit

February 10, 2026

Conditions

Prostate Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Detection rate of clinically significant prostate cancer

    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

    Up to 3 years

Study Arms (1)

Diagnostic (68Ga-PSMA-11, image-guided prostate biopsy)

EXPERIMENTAL

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 ProstateOther: Gallium Ga 68 GozetotideProcedure: Transrectal Ultrasonography Guided Biopsy

Interventions

Biopsy of ProstatePROCEDURE

Undergo image-guided prostate biopsy

Also known as: Prostate Biopsy, Prostatic Biopsy
Diagnostic (68Ga-PSMA-11, image-guided prostate biopsy)
Gallium Ga 68 GozetotideOTHER

Given IV

Also known as: (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
Diagnostic (68Ga-PSMA-11, image-guided prostate biopsy)
Transrectal Ultrasonography Guided BiopsyPROCEDURE

Undergo standard of care TRUS

Also known as: TRUS Biopsy, TRUS-Guided Biopsy
Diagnostic (68Ga-PSMA-11, image-guided prostate biopsy)

Eligibility Criteria

Age18 Years - 90 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

gallium 68 PSMA-1168Ga-DKFZ-PSMA-11

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Jeremie Calais

    UCLA / Jonsson Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2021

First Posted

December 16, 2021

Study Start

January 13, 2022

Primary Completion

July 10, 2025

Study Completion (Estimated)

January 7, 2027

Last Updated

February 12, 2026

Record last verified: 2025-09

Locations

US(1)