Neoadjuvant Androgen Deprivation Therapy Combined With Enzalutamide and Abiraterone Using Multiparametric MRI and 18FDCFPyL PET/CT in Newly Diagnosed Prostate Cancer

Completed · Phase 2

Conditions studied: Castrate Sensitive Prostate Cancer

In brief

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...

Key facts

Study ID: NCT03860987
Run by: National Cancer Institute (NCI)
People needed: 12
Starts: 2019-04-30
Expected to finish: 2026-05-18
Last updated by the study team: 2026-05-22

Who can join

Age: 18 and older, up to 99. Sex: male. Healthy volunteers: not accepted.

You may not qualify if…

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:
Bleeding disorders for which a prostate biopsy would pose a bleeding risk
PT/PTT greater than or equal to 1.5 times the upper limit of normal
Artificial heart valve
Contraindication to MRI:
Patients weighing more than the weight limit or unable to fit the scanner
Allergy to MR contrast agent
Patients with pacemakers, cerebral aneurysm clips, shrapnel injury or implantable electronic device
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
HIV-positive patients on antiretroviral therapy are ineligible because of potential pharmacokinetic interactions with study drugs. However, patients with long-standing (>5 years) HIV on antiretroviral therapy > 1 month (undetectable HIV viral load and CD4 count > 150 cells/microliter) may be eligible if the PI determines no anticipated clinically significant drug-drug interactions.
Patients undergoing active treatment for Hepatitis B or C infections.
Patients who have taken medications that are strong inhibitors or inducers of CYP3A4 or PgP within 14 days prior to enrollment and need to remain on these medications.
Other medications used for urinary symptoms including 5-alpha reductase inhibitors (finasteride and dutasteride) and alternative medications known to alter PSA (e.g., phytoestrogens and saw palmetto) cannot be taken while patients are receiving enzalutamide and abiraterone.
Contraindication to steroid use.
Patients with malignancy within the past 3 years for which study drugs or a prostatectomy is a contraindication.

Where it is running

National Institutes of Health Clinical Center — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.