Neoadjuvant Androgen Deprivation Therapy Combined With Enzalutamide and Abiraterone Using Multipa… (NCT03860987) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Neoadjuvant Androgen Deprivation Therapy Combined With Enzalutamide and Abiraterone Using Multiparametric MRI and 18FDCFPyL PET/CT in Newly Diagnosed Prostate Cancer
United States12 participantsStarted 2019-04-30
Plain-language summary
Background:
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.
Objective:
To develop improved techniques to localize and detect prostate cancer; and to develop new ways to treat prostate cancer
Eligibility:
Men ages 18 and older with prostate cancer that has not spread to other parts of the body
Design:
* 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 medications.
* 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 treatment.
* Participants will have a full medical evaluation before surgery to remove their prostate.
* 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 years...
Who can participate
Age range18 Years – 99 Years
SexMALE
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Inclusion criteria
✓. Patients must have histologically or cytologically confirmed prostate cancer confirmed by the Laboratory of Pathology, NCI, OR documented histopathological confirmation of prostate cancer from a CLIA-certified laboratory.
✓. Must have previously untreated (with definitive therapy ie: surgery, systemic treatment or radiation therapy) prostate cancer with intermediate or high risk features defined as:
✓. Patients must be eligible for and must be planning to undergo radical prostatectomy
✓. Patients must have testosterone levels greater than or equal to 100 ng/dL
✓. Men age greater than or equal to18 years.
✓. ECOG performance status 0-1.
✓. Patients must have adequate organ and marrow function, and other laboratory parameters as defined below:
✓. Lesions within prostate must be detectable on MRI for biopsy.
. Patients who are receiving any other investigational agents (in the past 28 days) or herbal medications (within 1 day prior to registration).
✕. Patients with evidence of distant metastatic disease beyond N1 (regional) lymph nodes on conventional imaging studies (e.g., CT, MRI or Bone Scan).
✕. Patients who have received any prior definitive therapy (ie: surgery, systemic treatment or radiation therapy) for prostate cancer.
✕. History of allergic reactions attributed to compounds of similar chemical or biologic composition to enzalutamide, abiraterone or other agents used in study.
✕. Clinically significant cardiac disease, e.g., New York Heart Association (NYHA) classes III-IV; uncontrolled angina, uncontrolled arrhythmia or uncontrolled hypertension (greater than or equal to 160/100 mmHg on two consecutive readings), myocardial infarction in the previous 6 months as confirmed by an electrocardiogram (ECG).
✕. Contraindication to biopsy:
✕. Contraindication to MRI:
✕. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.