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
概览
- 阶段
- 2 期
- 干预措施
- goserelin
- 疾病 / 适应症
- Castrate Sensitive Prostate Cancer
- 发起方
- National Cancer Institute (NCI)
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- disease status
- 状态
- 进行中（未招募）
- 最后更新
- 8天前
概览
简要总结
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
详细描述
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.
研究者
入排标准
入选标准
- •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:
- •Intermediate risk (patient must have at least one of the features listed below):
- •PSA level is between 10 and 20 ng/ml,
- •Gleason score is 7, OR
- •Stage T2b or T2c,
- •High risk (patient must have at least one of the features listed below):
- •PSA \> 20 at the time of diagnosis,
- •Gleason 8 or higher,
排除标准
- •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:
研究组 & 干预措施
1
Treatment
干预措施: goserelin
1
Treatment
干预措施: Enzalutamide
1
Treatment
干预措施: Radical Prostatectomy
1
Treatment
干预措施: Abiraterone
1
Treatment
干预措施: 18F-DCFPyL
1
Treatment
干预措施: Prednisone
结局指标
主要结局
disease status
时间窗: 2 months
The primary endpoint will be the disease status after completion of treatment relative to PSMA-PET imaging findings at 2 months
次要结局
- pathological complete response rate(5 years)