Pharmacokinetics of IA and IV Ga68-PSMA-11 Infusion

Summary

Prostate-specific membrane antigen (PSMA) agents have shown promise in detecting and treating prostate cancer. Gallium-68-labeled PSMA-11 (68Ga-PSMA-11) is a radioactive agent that binds to prostate cancer cells and can be imaged using positron emission tomography (PET) scanners that detect radioactivity in the body. This early phase I study will use PET to determine if delivering 68Ga-PSMA-11 directly into the prostatic artery (intra-arterial (IA) administration) results in greater uptake in the prostate than delivering 68Ga-PSMA-11 into a vein in the arm (intravenous (IV) administration).

Conditions

• Prostate Adenocarcinoma
• Prostate Carcinoma
• Stage IIC Prostate Cancer AJCC v8
• Stage III Prostate Cancer AJCC v8
• Stage IIIA Prostate Cancer AJCC v8
• Stage IIIB Prostate Cancer AJCC v8
• Stage IIIC Prostate Cancer AJCC v8
• Stage IV Prostate Cancer AJCC v8
• Stage IVA Prostate Cancer AJCC v8
• Stage IVB Prostate Cancer AJCC v8

Interventions

PROCEDURE

Angiogram

Undergo angiogram

PROCEDURE

Catheterization

Undergo prostatic arterial catheterization

DRUG

Gallium Ga-labeled PSMA-11

Given IV and IA

PROCEDURE

Positron Emission Tomography

Undergo PET scan

Sponsors & Collaborators

• Radiological Society of North America

  collaborator OTHER

• Ryan Kohlbrenner, MD

  lead OTHER

Principal Investigators

• Ryan Kohlbrenner · University of California, San Francisco

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-10-13

Primary Completion

2023-03-22

Completion

2023-03-22

FDA Drug

Yes

Countries

• United States

Study Locations