Assessing Radio-hybrid Prostate Specific Membrane Antigen (rhPSMA-7.3) (18F) in Healthy Volunteers and Subjects With Prostate Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-11

Study Completion Date

2020-04-16

Brief Summary

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A Phase 1, Open-label Study to Assess Safety, Biodistribution, and Internal Radiation Dosimetry of rhPSMA-7.3 (18F) Injection in Healthy Volunteers, and to Assess Safety and Investigate the Imaging Characteristics in Subjects With Prostate Cancer.

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Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Positron Emission Tomography (PET) Imaging study

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Healthy Volunteers

Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan

Group Type EXPERIMENTAL

rhPSMA-7.3 (18F) Injection

Intervention Type DRUG

Radioligand for PET CT scanning

Patients

Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan

Group Type EXPERIMENTAL

rhPSMA-7.3 (18F) Injection

Intervention Type DRUG

Radioligand for PET CT scanning

Interventions

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rhPSMA-7.3 (18F) Injection

Radioligand for PET CT scanning

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Male and females 21-65 years.
2. Clinically acceptable medical history

1. Male 18-80 years.
2. Histologically confirmed adenocarcinoma of the prostate
3. Clinically acceptable medical history
4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Exclusion Criteria

1. Received ionising radiation exposure from clinical trials or medical examinations or treatment in the last 12 months.
2. Suffers from claustrophobia.
3. Bilateral hip prostheses.

1. Biopsy 28 days prior to enrollment.
2. Extensive metastatic disease.
3. Underlying disease which might confound interpretation.
4. Bilateral hip prostheses.
5. High energy (\>300 Kiloelectron Volt (keV)) gamma-emitting radioisotope administered within five physical half-lives, or any intravenous iodinated contrast medium within 24 hours, or any high density oral contrast medium (oral water contrast is acceptable) within 5 days prior to study drug administration.
6. X-ray contrast agent (\<24 hr for intravenous agents and \<5 days for oral agents).
7. History of claustrophobia.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes