Total Body PET-CT Imaging of Prostate Cancer Using Illuccix

Early Phase 1

Recruiting

• Conditions: Metastatic Castration-resistant Prostate Cancer
• Interventions: Drug: illuccix 68Ga-PSMA-11 Total Body PET-CT

• Registration Number: NCT05558956
• Lead Sponsor: BAMF Health

Brief Summary

Illuccix will be used per the prescribing instructions for PET-CT imaging on the United Imaging scanner uEXPLORER to establish a standard scanning protocol.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-23
• Study First Submitted QC: 2022-09-26
• Study First Posted: 2022-09-28
• Study Start: 2022-11-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-07-25
• Last Update Posted: 2023-07-27
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

1. Provision of signed and dated informed consent form

2. Male ≥ 18 years of age

3. Patients meeting clinical need for Illuccix PET scan:

   1. Patients with suspected metastasis who are candidates for initial definitive therapy
   2. Patients with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level

4. Patient is physically able to lay flat for the PET-CT procedure

Exclusion Criteria

1. Assessment by the Investigator as unable or unwilling to comply with the requirements of the protocol.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Dose	illuccix 68Ga-PSMA-11 Total Body PET-CT	3 mCi dose of 68Ga-PSMA-11 (Illuccix) and a total body PET-CT scan for 4-6 min scan time.
High dose	illuccix 68Ga-PSMA-11 Total Body PET-CT	7 mCi dose of 68Ga-PSMA-11 (Illuccix) and a total body PET-CT scan for 4-6 min scan time.

Primary Outcome Measures

Name	Time	Method
Comparing the imaging quality using low dose and high dose Ga-68 PSMA-11 at various scan lengths.	3 months	In modulating the dose and scan time, including reconstitution of the images, we will identify optimal protocol for use of Illuccix on total body PET/CT through evaluation of image quality at variable dose and scan length.

Trial Locations

Locations (1)

BAMF Health; 🇺🇸 Grand Rapids, Michigan, United States