Status:
WITHDRAWN
Study of 18F-DCFPyL PET/CT Imaging in Patients With Prostate Cancer
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- Patient will be excluded from enrollment if he had a radioisotope within 5 physical half-lives prior to PET imaging
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 21 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03800784
Start Date
October 1 2019
End Date
October 21 2021
Last Update
December 15 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Johns Hopkins University
Baltimore, Maryland, United States, 21287