Phase 2
N=225
Evaluation of Gallium-68-HBED-CC-PSMA Imaging in Prostate Cancer Patients
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02611882 ↗Enrolled (actual)
225
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Sensitivity of Ga-68 HBED-CC PSMA for Detection of Nodal Metastases — .59; .89 proportion of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ga-68 labeled HBED-CC PSMA (Drug); 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) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Thomas Hope
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensitivity of Ga-68 HBED-CC PSMA for Detection of Nodal Metastases |
.59; .89 | — |
| PRIMARY Specificity of Ga-68 HBED-CC PSMA for Detection of Nodal Metastasis |
.80; .31 | — |
| PRIMARY Positive Predictive Value (PPV) of Ga-68 HBED-CC PSMA for Detection of Nodal Metastasis |
.67; .906 | — |
| PRIMARY Negative Predictive Value (NPV) of Ga-68 HBED-CC PSMA for Detection of Nodal Metastasis |
.74; .24 | — |
| SECONDARY Overall Detection Rates of Ga68-PSMA-11 by PSA Levels for the BCR Group |
.55; .62; .80; .88; .96 | — |
| SECONDARY Number of Patients in Biochemical Recurrence (BCR) Group Who Had a Reported Change in Medical Management |
67; 8 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
- Age > 18.
- Karnofsky performance status of > 50 (or Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) equivalent).
- Ability to understand a written informed consent document, and the willingness to sign it.
Exclusion Criteria
- Patients exceeding the weight limitations of the scanner or are not able to enter the bore of the PET scanner due to BMI.
- Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.).
- Inability to complete the needed investigational due to other reasons (severe claustrophobia, radiation phobia, etc.).
Data sourced from ClinicalTrials.gov (NCT02611882). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.