Prostate cancer is a common cancer among men. There are several ways to treat it, including
hormone blocking drugs, radiation therapy, and surgery. Researchers want to combine
abiraterone and enzalutamide to see if there is a better way to treat prostate cancer. They
also want to study a new radiotracer called 18F-DCFPyL, with the help of a scan called
positron emission tomography/computed tomography (PET/CT) to see if there is a better way to
detect prostate cancer.
To develop improved techniques to localize and detect prostate cancer; and to develop new
ways to treat prostate cancer
Men ages 18 and older with prostate cancer that has not spread to other parts of the body
Participants will have a medical evaluation to determine eligibility for the study.
Participants will take three different medications daily by mouth and receive two
injections during the course of the study.
Participants will have a medical evaluation monthly (for 6 months) while taking the
Participants will have prostate MRI and PET/CT scans before treatment, 2 months after
starting treatment and again before surgery. The radiotracer will be given by injection
about 2 hours before the whole-body scan. The PET/CT scan itself is about an hour.
Participants may be asked to do a biopsy before treatment and 2 months after starting
Participants will have a full medical evaluation before surgery to remove their
Participants will have a follow-up visit 3 months after surgery and then as needed.
Participants will be contacted once a year for their PSA and testosterone levels for 5
Most men diagnosed with prostate cancer will present with intermediate or high-risk
disease, and many develop castrate resistant prostate cancer (CRPC) as curative
strategies are often unsuccessful
Treatment options typically involve radical prostatectomy (RP) or radiation therapy (RT)
in combination with androgen deprivation therapy (ADT)
PET imaging based on prostate specific membrane antigen (PSMA), including use of the
radiotracer DCFPyL, which binds PSMA, has emerged as a sensitive modality to detect
localized and metastatic prostate cancer
It is unknown how androgen-targeted therapy affects expression of the androgenregulated
PSMA gene, FOLH1, and 18F -DCFPyL-PET/CT sensitivity; and, the correlation
between response on 18F -DCFPyL-PET/CT imaging and clinical response needs further
The use of highly effective androgen pathway inhibitors enzalutamide and abiraterone
offers an opportunity to understand the characteristics of 18F -DCFPyL-PET imaging
during treatment while potentially improving the cure rate of men with potentially
lethal localized prostate cancer
There remains a great need for improved techniques to determine mechanisms of treatment
response and resistance
To test the feasibility of 18F -DCFPyL-PET/CT for the localization of prostate cancer
before, during, and after pre-operative treatment with ADT, enzalutamide, and
abiraterone/prednisone in patients negative for metastatic disease
Pathologic diagnosis of castration-sensitive prostate cancer with intermediate- or highrisk
features and no evidence of metastases beyond N1 on conventional imaging
Candidates for radical prostatectomy
Testosterone levels greater than or equal to 100 ng/dL
ECOG PS 0-1
Men age greater than or equal to 18 years
Patients will be treated with ADT, enzalutamide, and abiraterone/prednisone for 6
months, followed by standard of care radical prostatectomy (RP)
18F-DCFPyL-PET/CT and mpMRI scans prior to treatment, during months 3-5 and after 6
months of treatment
Prostate tumor biopsy (MR/US-guided) samples for research analyses at baseline and after
mid-treatment imaging (post-month 2)
It is anticipated that approximately 1.5 to 2 years may be required for accrual of up to
25 evaluable subjects.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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