Neoadjuvant Androgen Deprivation Therapy Combined With Enzalutamide and Abiraterone Using Multiparametric MRI and 18FDCFPyL PET/CT in Newly Diagnosed Prostate Cancer
- Conditions
- Castrate Sensitive Prostate Cancer
- Interventions
- Procedure: Radical Prostatectomy
- Registration Number
- NCT03860987
- Lead Sponsor
- National Cancer Institute (NCI)
- Brief 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...
- Detailed Description
Background:
* 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 androgen- regulated 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 evaluation
* 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
Objectives:
- 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
Eligibility:
* Pathologic diagnosis of castration-sensitive prostate cancer with intermediate- or high- risk 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
Design:
* 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Male
- Target Recruitment
- 12
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 goserelin Treatment 1 Enzalutamide Treatment 1 Prednisone Treatment 1 Abiraterone Treatment 1 18F-DCFPyL Treatment 1 Radical Prostatectomy Treatment
- Primary Outcome Measures
Name Time Method disease status 2 months The primary endpoint will be the disease status after completion of treatment relative to PSMA-PET imaging findings at 2 months
- Secondary Outcome Measures
Name Time Method pathological complete response rate 5 years Evaluate the pathological complete response rate after neoadjuvant treatment with ADT, enzalutamide, and abiraterone/prednisone
Trial Locations
- Locations (1)
National Institutes of Health Clinical Center
🇺🇸Bethesda, Maryland, United States