Total Body PET-CT Imaging of Prostate Cancer Using Illuccix

BAMF Health

Status and phase: Enrolling; Early Phase 1

Conditions: Metastatic Castration-resistant Prostate Cancer

Treatments: Drug: illuccix 68Ga-PSMA-11 Total Body PET-CT

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05558956

BAMF-2022-03

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Low Dose

Experimental group

Description:

3 mCi dose of 68Ga-PSMA-11 (Illuccix) and a total body PET-CT scan for 4-6 min scan time.

Treatment:

Drug: illuccix 68Ga-PSMA-11 Total Body PET-CT

High dose

Experimental group

Description:

7 mCi dose of 68Ga-PSMA-11 (Illuccix) and a total body PET-CT scan for 4-6 min scan time.

Treatment:

Drug: illuccix 68Ga-PSMA-11 Total Body PET-CT