Prostate Cancer
Conditions
Keywords
18F-DCFPyL PET/CT PyL, PSMA
Brief summary
This study evaluates the rate of radiological disease progression with the new 2nd generation positron emission tomography (PET) radiopharmaceutical, 18F-DCFPyL, in patients with metastatic castration (mCRPC) and non-metastatic (nmCRPC) castration resistant prostate cancer who have evidence of biochemical (PSA) disease progression without evidence of radiological disease progression on conventional standard radiologic testing (99mTc-methylene diphosphonate bone scan and CT).
Interventions
A single dose of 9±1 mCi (333±37 MBq) IV injection of 18F-DCFPyL
Sponsors
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histological confirmation of prostate cancer * Patients receiving androgen deprivation treatment (ADT) with GnRH analogs, GnRH antagonists or bilateral orchiectomy of any duration. * Cohort A: nmCRPC (status post- primary treatment with radical prostatectomy, radiation of any type or both) * Negative 99mTc-methylene diphosphonate bone scan and CT of the chest abdomen and pelvis within 6 weeks of 18F-DCFPyL PET/CT * Treatment with ADT with or without a second line novel AR targeted treatment (abiraterone, enzalutamide, or both) or 4 weeks after discontinuation of first generation antiandrogen (bicalutamide , flutamide, nilutamide- one or more permitted) for ≥ 12 months. * Rising PSA ≥ 10 ng/ml (confirmed by 2 determinations one week apart) * PSADT ≤ 9 months * Cohort B: mCRPC * Treatment with ADT with or without abiraterone and or enzalutamide or both for ≥ 6 months and/or 4 weeks after discontinuation of first generation antiandrogen (bicalutamide , flutamide, nilutamide- one or more permitted). * PSA ≥ 2.0 ng/ml confirmed X 1 week apart, any PSADT * Patients enrolled in other clinical trials are eligible if they satisfy all other criteria of eligibility. * No new therapeutic interventions planned or scheduled to be instituted prior to the course of this study both on cohorts A and B before conventional radiologic progression is evidenced. * Patients or their legal representatives must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures.
Exclusion criteria
* Patient will be excluded from enrollment if he had a radioisotope within 5 physical half-lives prior to PET imaging
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity 18F-DCFPyL PET/CT imaging to detect metastatic prostate cancer | 3 years | Proportion of patients demonstrating disease progression by conventional criteria evaluated by CT scan and 99mTc-methylene diphosphonate bone scan and on 18F-DCFPyL PET/CT. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of findings on 18F-DCFPyL PET/CT with conventional imaging as determined by Number of Lesions detected on each imaging modality | 3 years | Number of lesions detected on 18F-DCFPyL PET/CT in comparison to number of lesions detected on conventional imaging (99mTc-methylene diphosphonate bone scan and CT) |
Countries
United States
Outcome results
None listed