Gallium-68 PSMA-11 PET Imaging in Prostate Cancer Patients

Thomas Hope

Status and phase: Completed; Phase 3

Conditions: Prostate Cancer

Treatments: Device: Positron emission tomography-computed tomography (PET/CT); Drug: Ga-68 labeled PSMA-11; Device: Positron emission tomography-magnetic resonance imaging (PET/MRI)

Study type: Interventional

Funder types: Other

Identifiers

NCT03803475

NCI-2019-01394 (Registry Identifier)

185513

Details and patient eligibility

About

The investigators are imaging patients with prostate cancer using a new Positron Emission Tomography (PET) imaging agent (Ga-68-PSMA-11) in order to evaluate its ability to detect prostate cancer.

Full description

Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if there is presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol. PET imaging will begin 50-100 minutes after injection, but may be possible in certain circumstances for imaging to be delayed due to patient workflow or equipment issues

Primary Objective:

Sensitivity on a per-patient and per-region-basis (Table 1) of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy, clinical and conventional imaging follow-up.

Enrollment: 485 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male, age >= 18.

2. Histopathologically proven prostate adenocarcinoma.

3. Concern for metastatic disease in one of the following settings:

   1. Initial staging with intermediate to high risk prostate cancer.
   2. Biochemical recurrence after initial therapy.

4. Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion criteria

1. Patient unlikely to comply with study procedures, restrictions and requirements and judged by the Investigator to be unsuitable for study participation.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

485 participants in 1 patient group

Ga-68 labeled PSMA-11 PET PSMA

Experimental group

Description:

The imaging agent (Ga-68 PSMA-11 or PSMA-HBED-CC) will be administered on an outpatient basis. It will be administered a single time intravenously prior to the PET imaging. The injected dose will be 3 to 7 millicurie (mCi) +/- 10% of 68Ga-PSMA-11.

Treatment:

Device: Positron emission tomography-magnetic resonance imaging (PET/MRI)

Drug: Ga-68 labeled PSMA-11

Device: Positron emission tomography-computed tomography (PET/CT)