Neoadjuvant Androgen Deprivation Therapy Combined With Enzalutamide and Abiraterone Using Multiparametric MRI and 18FDCFPyL PET/CT in Newly Diagnosed Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT03860987|
Recruitment Status : Recruiting
First Posted : March 4, 2019
Last Update Posted : January 25, 2021
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 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...
|Condition or disease||Intervention/treatment||Phase|
|Castrate Sensitive Prostate Cancer||Drug: goserelin Drug: Enzalutamide Drug: Abiraterone Drug: 18F-DCFPyL Drug: Prednisone Procedure: Radical Prostatectomy||Phase 2|
- 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
- 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 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
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Neoadjuvant Androgen Deprivation Therapy Combined With Enzalutamide and Abiraterone Using Multiparametric MRI and 18F-DCFPyL-PET/CT in Newly Diagnosed Prostate Cancer|
|Actual Study Start Date :||April 30, 2019|
|Estimated Primary Completion Date :||August 31, 2025|
|Estimated Study Completion Date :||August 1, 2026|
Goserelin will be administered SC at 10.8 mg every 12 weeks
Enzalutamide will be given orally at 160mg once daily
Abiraterone will be taken orally at 1000 mg once daily
18F-labeled agent that is a high affinity small molecule inhibitor of PSMA to detect prostate cancer via PET imaging
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
- disease status [ Time Frame: 2 months ]The primary endpoint will be the disease status after completion of treatment relative to PSMA-PET imaging findings at 2 months
- pathological complete response rate [ Time Frame: 5 years ]Evaluate the pathological complete response rate after neoadjuvant treatment with ADT, enzalutamide, and abiraterone/prednisone
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03860987
|Contact: Katherine O Lee-Wisdom, R.N.||(240) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office 888-624-1937|
|Principal Investigator:||William L Dahut, M.D.||National Cancer Institute (NCI)|