Image-Guided (68Ga-PSMA-11 PET/CT) Prostate Biopsy for the Diagnosis of Prostate Cancer in Men With Prior Negative/Inconclusive Biopsy

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

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05160597

Enrollment

Registered

2021-12-16

Start date

2022-01-13

Completion date

2027-01-07

Last updated

2026-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Carcinoma

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).

Interventions

PROCEDUREBiopsy of Prostate

Undergo image-guided prostate biopsy

OTHERGallium Ga 68 Gozetotide

Given IV

PROCEDURETransrectal Ultrasonography Guided Biopsy

Undergo standard of care TRUS

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 90 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Detection rate of clinically significant prostate cancer	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

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORJeremie Calais

UCLA / Jonsson Comprehensive Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026