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

Jonsson Comprehensive Cancer Center

Status and phase: Active, not recruiting; Early Phase 1

Conditions: Prostate Carcinoma

Treatments: Other: Gallium Ga 68 Gozetotide; Procedure: Biopsy of Prostate; Procedure: Transrectal Ultrasonography Guided Biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT05160597

NCI-2021-12975 (Registry Identifier)

21-001122

Details and patient eligibility

About

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.

Full 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).

Enrollment: 30 estimated patients

Sex: Male

Ages: 18 to 90 years old

Volunteers: No 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)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

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

Experimental group

Description:

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.

Treatment:

Procedure: Transrectal Ultrasonography Guided Biopsy

Procedure: Biopsy of Prostate

Other: Gallium Ga 68 Gozetotide