Evaluation of Gallium-68-HBED-CC-PSMA Imaging in Prostate Cancer Patients (PSMA PET)

Thomas Hope

Status and phase: Completed; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: Ga-68 labeled HBED-CC PSMA; Device: Positron Emission Tomography (PET) image combined with Magnetic Resonance Imaging (MRI) (PET/MRI); Device: Positron Emission Tomography (PET) image combined with Computed Tomography (CT) (PET/CT)

Study type: Interventional

Funder types: Other

Identifiers

NCT02611882

15554

NCI-2018-00037 (Registry Identifier)

Details and patient eligibility

About

The investigators are imaging patients with prostate cancer using a new PET imaging agent (Ga-68 HBED-CC PSMA) in order to evaluate it's ability to detection prostate cancer in patients with high risk disease prior to prostatectomy, patients with biochemical recurrence and patients with castrate resistant prostate cancer.

Full description

Imaging and staging of prostate cancer is critical for surgical and treatment planning. Patients with suspected metastatic prostate cancer will be imaged using Gallium-68 labeled HBED-CC PSMA in order to demonstrate its utility. The investigators plan to utilize this data to obtain further approvals of the HBED-CC PSMA compound, so that this agent will become available for clinical imaging in prostate cancer patients.

This compound has been shown to be superior to choline based PET agents for the staging of prostate cancer, both Carbon-11 and Fluorine-18 compounds. But this compound was not patented and therefore no company or private entity will make the investment required to bring HBED-CC PSMA to market. In the vacuum of availability, academic groups must take the lead in order to collect the necessary data for future FDA approval.

This study focuses on three patients populations that are imaged. In the pre-prostatectomy population, the primary objective is to determine the sensitivity and specificity for detection on nodal metastasis. In the biochemical recurrence population, the primary objective is to determine the sensitivity of recurrence location. In the castrate resistant prostate cancer population the primary objective is to determine if PSMA PET detects more metastatic lesions than conventional imaging.

Enrollment: 225 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Known prostate cancer with a clinical concern for the presence of metastatic disease as delineated below:

   • Treatment naïve patients with one of the following risk factors: CAPRA (Cancer of the Prostate Risk Assessment) score ≥ 5, Prostate-specific antigen (PSA) ≥ 15 ng/mL and/or Gleason score ≥ 4+4.

   • Patients with biochemical recurrence after prostatectomy or radiation therapy with a PSA doubling time less than 12 months.

     i. These patients may have received androgen deprivation therapy prior to imaging.

   • Patients with castrate resistant prostate cancer with progressive disease as defined by Prostate Cancer Clinical Trials Working Group (PCWG2) criteria (27).

     i. Patients with castrate resistant prostate cancer can be either on treatment or off treatment

2. Age > 18.

3. Karnofsky performance status of > 50 (or Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) equivalent).

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

Exclusion criteria

1. Patients exceeding the weight limitations of the scanner or are not able to enter the bore of the PET scanner due to BMI.
2. Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.).
3. Inability to complete the needed investigational due to other reasons (severe claustrophobia, radiation phobia, etc.).

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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225 participants in 3 patient groups

High-risk prostate cancer pre-prostatectomy (preRP) population

Experimental group

Description:

Patients with high-risk prostate cancer pre-prostatectomy. Patients receive Ga-68-HBED-CC-PSMA and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.

Treatment:

Device: Positron Emission Tomography (PET) image combined with Computed Tomography (CT) (PET/CT)

Device: Positron Emission Tomography (PET) image combined with Magnetic Resonance Imaging (MRI) (PET/MRI)

Drug: Ga-68 labeled HBED-CC PSMA

Biochemical Recurrence (BCR)

Experimental group

Description:

Patients with prostate cancer with biochemical recurrence Patients receive Ga-68-HBED-CC-PSMA and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.

Treatment:

Device: Positron Emission Tomography (PET) image combined with Computed Tomography (CT) (PET/CT)

Device: Positron Emission Tomography (PET) image combined with Magnetic Resonance Imaging (MRI) (PET/MRI)

Drug: Ga-68 labeled HBED-CC PSMA

Castrate Resistant Prostate cancer (CRCP) population

Experimental group

Description:

Patients with castrate resistant prostate cancer. Patients receive Ga-68-HBED-CC-PSMA and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.

Treatment:

Device: Positron Emission Tomography (PET) image combined with Computed Tomography (CT) (PET/CT)

Device: Positron Emission Tomography (PET) image combined with Magnetic Resonance Imaging (MRI) (PET/MRI)

Drug: Ga-68 labeled HBED-CC PSMA