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Title:
Study of 18F-DCFPyL PET/CT, for detection of radiological progression in patients with metastatic (M+) and non-metastatic (M0) castration resistant prostate cancer receiving standard androgen receptor targeted treatment
Protocol Number:
J1863
Phase:
Phase II
Physician:
Mark Markowski
Sites:
Johns Hopkins Kimmel Cancer Center in Baltimore
Purpose:
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).
Eligibility:
For Cohort A: nmCRPC, nonmetastatic castration-resistant prostate cancer (status post- primary treatment with radical prostatectomy, radiation of any type or both), patients must have 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 equal to 12 months, rising PSA equal to 10 ng/ml (confirmed by 2 determinations one week apart) and PSADT equal to 9 months. For Cohort B mCRPC, metastatic castration-resistant prostate cancer, patient must have received treatment with ADT with or without abiraterone and or enzalutamide or both for equal to 6 months and/or 4 weeks after discontinuation of first generation antiandrogen (bicalutamide , flutamide, nilutamide- one or more per 2) and PSA equal to 2.0 ng/ml confirmed X 1 week apart, any PSADT.
Treatment:
There are two study groups: Cohort A: nmCRPC, nonmetastatic castration-resistant prostate cancer (status post- primary treatment with radical prostatectomy, radiation of any type or both), and Cohort B mCRPC, metastatic castration-resistant prostate cancer. For Cohort A, patients will have a baseline PET/CT scan. At about 60 minutes after injection of the 18F-DCFPyL radiotracer, patients will have a PET/CT scan. If the PET/CT scan with the radiotracer shows possible evidence of cancer in areas outside the prostate, patients will come off study and the study doctor will discuss treatment options. If there is no evidence of cancer in areas outside the prostate, patients will have a second PET/CT scan performed on month 6. For Cohort B: patients will have a baseline PET/CT scan and a second PET/CT scan performed on month 3.
Population:
Adult
Last Update
12/09/2019 05:03 AM