ARN-509 and Leuprolide in Intermediate and High-risk Prostate Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02770391|
Recruitment Status : Recruiting
First Posted : May 12, 2016
Last Update Posted : February 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Leuprolide acetate Drug: ARN-509 Procedure: Radical prostatectomy||Phase 2|
Primary Objective: To evaluate the differential effect of neo-adjuvant leuprolide and ARN-509 on dihydrotestosterone (DHT) concentration in benign prostate tissue based on HSD3B1 genotype.
Secondary Objective(s): To evaluate the differential effect of neoadjuvant leuprolide and ARN-509 on other androgen (testosterone (T), dehydroepiandrosterone (DHEA), androstenediol, 5α-androstanedione (5α-dione), androstenedione (AD), androsterone and 5α-androstanediol) concentrations in benign and malignant prostate tissue based on HSD3B1 genotype.
To compare the level of DHT, T, DHEA, androstenediol, 5α-dione, AD, androsterone and 5α-androstanediol between normal and malignant prostate tissue after neoadjuvant treatment with leuprolide and ARN-509
To determine the safety of the combination of Leuprolide and ARN-509 administered prior to radical prostatectomy
To evaluate prostatic specific antigen (PSA), FKBP5, TMPRSS2, EZH2, H3K27 and UBE2C tissue expression (via immunohistochemistry (IHC) and quantitative polymerase chain reaction (qPCR)) in benign and malignant prostate tissue after treatment with Leuprolide and ARN-509 and ARN-509.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||57 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Association Between HSD3B1 Genotype and Steroid Metabolism in Normal and Prostate Cancer Tissue of Men With Intermediate and High-risk Prostate Cancer Undergoing Radical Prostatectomy After Treatment With ARN-509 and Leuprolide|
|Actual Study Start Date :||October 17, 2016|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||April 2020|
Experimental: ARN-509 + Leuprolide Acetate
All participating patients will receive a single dose of leuprolide 7.5 mg intramuscularly (IM) in addition to ARN-509 240 mg orally daily for four weeks prior to radical prostatectomy (RP). Treatment will be started on day (-28) ± 3 from the scheduled RP date to minimize the variability of treatment duration. ARN-509 will be continued till the day of RP.
Drug: Leuprolide acetate
Leuprolide acetate, Intramuscular injection - 7.5 mg, one time dose on day (-28) ± 3
Other Name: Lupron
ARN-509, PO, 240 mg daily, starting day (-28) ± 3 until the day before radical prostatectomy. ARN-509 will be initiated the same day patients receive their leuprolide acetate injection.
Procedure: Radical prostatectomy
- dihydrotestosterone (DHT) concentration in benign prostate tissue after a combination drug treatment based on genotype status [ Time Frame: Up to 28 Days ]To evaluate the differential effect of neo-adjuvant leuprolide and ARN-509 on dihydrotestosterone (DHT) concentration in benign prostate tissue based on HSD3B1 genotype.
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): NCT02770391
|Contact: Jorge A Garcia, MD, FACPemail@example.com|
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center||Recruiting|
|Cleveland, Ohio, United States, 44195|
|Contact: Jorge A Garcia, MD, FACP 216-444-9464 firstname.lastname@example.org|
|Principal Investigator: Jorge A Garcia, MD, FACP|
|Principal Investigator:||Jorge A Garcia, MD, FACP||Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center|