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

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...

Conditions

• Castrate Sensitive Prostate Cancer

Interventions

DRUG

goserelin

Goserelin will be administered SC at 10.8 mg every 12 weeks

DRUG

Enzalutamide

Enzalutamide will be given orally at 160mg once daily

DRUG

Abiraterone

Abiraterone will be taken orally at 1000 mg once daily

DRUG

18F-DCFPyL

18F-labeled agent that is a high affinity small molecule inhibitor of PSMA to detect prostate cancer via PET imaging

DRUG

Prednisone

Prednisone will be taken orally at 5mg twice a day for each dose, or 10 mg once a day. Doses should be taken about 12 or 24 hours apart

PROCEDURE

Radical Prostatectomy

Radical Prostatectomy

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Fatima H Karzai, M.D. · National Cancer Institute (NCI)

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-04-30

Primary Completion

2026-05-11

Completion

2026-05-18

FDA Drug

Yes

Countries

• United States

Study Locations