Clinical Trial · NCT02856100

Comparison of PSMA-based 18F-DCFPyL PET/CT to Conventional Imaging in the Evaluation of Patients With Castration-Resistant Prostate Cancer

Overview

We intend to validate 18F-DCFPyL for imaging patients with metastatic, castrate-resistant PCa (CRPC), so that it may be used to full advantage in supporting existing and emerging therapies for a spectrum of patients suffering from PCa. In this study we will image patients with CRPC undergoing second-line anti-androgen therapy (enzalutamide or abiraterone) using 18F-DCFPyL-PET/CT for detection of metastases and therapeutic monitoring, with correlation to standard-of-care conventional imaging modalities (CIM) (CT, bone scan) and clinical follow-up.

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Contacts

Steven Rowe, MD, PhD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT02856100

Drug / Compound

DCFPyL

Isotope(s):

Target(s):

PSMA

Ligand Class: Small Molecules

Eligibility

Inclusion

Serum albumin ≥ 30 g/L
Platelet count ≥ 100,000/μL
Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology
Rising PSA over a minimum 1-week interval
Prior docetaxel-based chemotherapy is permitted but not required
Serum potassium ≥ 3.5 mmol/L
Ongoing androgen deprivation with serum testosterone \< 50 ng/dL (\< 1.7 nM)
Patients starting abiraterone (but naïve to enzalutamide) or starting enzalutamide (but naïve to abiraterone)
Hemoglobin ≥ 90 g/L independent of transfusion
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
Documented metastatic prostate cancer progression as assessed by the treating oncologist with either one or both of the following:
Serum creatinine \< 1.5 x ULN or a calculated creatinine clearance ≥ 60 mL/min
Radiographic progression in soft tissue and/or bone

Exclusion

History of gastrointestinal disorders (medical disorders or extensive surgery) which may interfere with the absorption of orally administered hormonal agents.
Patients who have partners of childbearing potential who are not willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator and sponsor during the study and for 13 weeks after last study drug administration
Acute toxicities due to prior chemotherapy and/or radiotherapy that have not resolved to a NCI CTCAE (version 4.0) grade of ≤ 1; chemotherapy-induced alopecia and grade 2 peripheral neuropathy are allowed
Serum bilirubin ≥ 1.5 x ULN (except for patients with documented Gilbert's disease)
Current enrollment in an investigational drug or device study, or participation in such a study within 30 days of first administration of the hormonal agent.
AST or ALT ≥ 2.5 x ULN, (for patients with known liver metastasis, AST or ALT ≤ 5 x ULN is allowed)
Active or symptomatic viral hepatitis or chronic liver disease
Abnormal liver functions consisting of any of the following:
Known brain metastasis
Condition or situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with patient's participation in the study
Condition or situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with patient's participation in the study
History of pituitary or adrenal dysfunction
Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class III or IV heart disease or cardiac ejection fraction measurement of \< 50 % at baseline
Uncontrolled hypertension (systolic BP ≥ 160 mmHg or diastolic BP ≥ 95 mmHg)
Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
Not willing to comply with the procedural requirements of this protocol