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

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins1 site in 1 country18 target enrollmentAugust 3, 2016

ConditionsProstate Cancer

Interventions18F DCFPyL- Radiopharmaceutical

Drugs18F DCFPyL- Radiopharmaceutical

Overview

Phase: Not Applicable
Intervention: 18F DCFPyL- Radiopharmaceutical
Conditions: Prostate Cancer
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Enrollment: 18
Locations: 1
Primary Endpoint: Change in number of metastatic lesions detected on 18F-DCFPyL PET/CT
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

August 3, 2016

End Date

January 2020

Last Updated

5 years ago

Study Type

Observational

Sex

Male

Investigators

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Willing and able to provide written informed consent
•Age ≥ 18 years and male
•Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology
•Patients starting abiraterone (but naïve to enzalutamide) or starting enzalutamide (but naïve to abiraterone)
•Prior docetaxel-based chemotherapy is permitted but not required
•Documented metastatic prostate cancer progression as assessed by the treating oncologist with either one or both of the following:
•Rising PSA over a minimum 1-week interval
•Radiographic progression in soft tissue and/or bone
•Ongoing androgen deprivation with serum testosterone \< 50 ng/dL (\< 1.7 nM)
•Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2

Exclusion Criteria

•Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
•Abnormal liver functions consisting of any of the following:
•Serum bilirubin ≥ 1.5 x ULN (except for patients with documented Gilbert's disease)
•AST or ALT ≥ 2.5 x ULN, (for patients with known liver metastasis, AST or ALT ≤ 5 x ULN is allowed)
•Uncontrolled hypertension (systolic BP ≥ 160 mmHg or diastolic BP ≥ 95 mmHg)
•Active or symptomatic viral hepatitis or chronic liver disease
•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
•Other malignancy, except non-melanoma skin cancer, with a ≥ 30% probability of recurrence within 12 months
•Known brain metastasis

Arms & Interventions

Patients with CRPC, evidence of metastases, planned treatment

Intervention: 18F DCFPyL- Radiopharmaceutical

Outcomes

Primary Outcomes

Change in number of metastatic lesions detected on 18F-DCFPyL PET/CT

Time Frame: up to 2 years

Change in number of metastatic lesions detected from baseline standard of care conventional imaging (CT and Bone Scan) to 18F-DCFPyL PET/CT at 8-12 weeks post- anti-androgen therapy (standard of care)