Clinical trial NCT02611882: Evaluation of Gallium-68-HBED-CC-PSMA Imaging in Prostate Cancer Patients
Official title: Evaluation of Gallium-68 HBED-CC-PSMA Imaging in Prostate Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2015-11-23
Enrollment: 225
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.).

Primary outcomes:
measure: Sensitivity of Ga-68 HBED-CC PSMA for Detection of Nodal Metastases
timeFrame: 1 day
measure: Specificity of Ga-68 HBED-CC PSMA for Detection of Nodal Metastasis
timeFrame: 1 day
measure: Positive Predictive Value (PPV) of Ga-68 HBED-CC PSMA for Detection of Nodal Metastasis
timeFrame: 1 day
measure: Negative Predictive Value (NPV) of Ga-68 HBED-CC PSMA for Detection of Nodal Metastasis
timeFrame: one month
Secondary outcomes:
measure: Overall Detection Rates of Ga68-PSMA-11 by PSA Levels for the BCR Group
timeFrame: Up to 1 year
measure: Number of Patients in Biochemical Recurrence (BCR) Group Who Had a Reported Change in Medical Management
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Thomas Hope
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lawhn-Heath C, Flavell RR, Behr SC, Yohannan T, Greene KL, Feng F, Carroll PR, Hope TA. Single-Center Prospective Evaluation of 68Ga-PSMA-11 PET in Biochemical Recurrence of Prostate Cancer. AJR Am J Roentgenol. 2019 Aug;213(2):266-274. doi: 10.2214/AJR.18.20699. Epub 2019 Apr 30.
citation: Hope TA, Eiber M, Armstrong WR, Juarez R, Murthy V, Lawhn-Heath C, Behr SC, Zhang L, Barbato F, Ceci F, Farolfi A, Schwarzenbock SM, Unterrainer M, Zacho HD, Nguyen HG, Cooperberg MR, Carroll PR, Reiter RE, Holden S, Herrmann K, Zhu S, Fendler WP, Czernin J, Calais J. Diagnostic Accuracy of 68Ga-PSMA-11 PET for Pelvic Nodal Metastasis Detection Prior to Radical Prostatectomy and Pelvic Lymph Node Dissection: A Multicenter Prospective Phase 3 Imaging Trial. JAMA Oncol. 2021 Nov 1;7(11):1635-1642. doi: 10.1001/jamaoncol.2021.3771.
citation: Hope TA, Aggarwal R, Chee B, Tao D, Greene KL, Cooperberg MR, Feng F, Chang A, Ryan CJ, Small EJ, Carroll PR. Impact of 68Ga-PSMA-11 PET on Management in Patients with Biochemically Recurrent Prostate Cancer. J Nucl Med. 2017 Dec;58(12):1956-1961. doi: 10.2967/jnumed.117.192476. Epub 2017 May 18.