Abiraterone Acetate Combined With Dutasteride for Metastatic Castrate Resistant Prostate Cancer
Phase II Trial of Abiraterone Acetate Combined With Dutasteride With Correlative Assessment of Tumor Androgen Levels and Androgen Receptor Sequence and Signaling at Baseline and at Progression
1 other identifier
interventional
40
1 country
4
Brief Summary
The purpose of this research study is to determine if the addition of dutasteride to a regimen with abiraterone acetate and prednisone will improve on therapy in patients with castrate-resistant prostate cancer and metastatic disease. This study will also help determine the side effects of the study treatment and how often they occur.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 prostate-cancer
Started Sep 2011
Typical duration for phase_2 prostate-cancer
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 21, 2011
CompletedFirst Posted
Study publicly available on registry
July 13, 2011
CompletedStudy Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2017
CompletedResults Posted
Study results publicly available
June 14, 2017
CompletedMarch 15, 2018
February 1, 2018
4.3 years
June 21, 2011
March 17, 2017
February 16, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Androgen Receptor (AR) Related Mutations
AR related mutation was defined as presence of T878A mutation. Expression of T878A was measured by established methods.
Pairs of patients samples were evaluated at baseline and time of progression. In this study cohort, participants were followed up to 48 months for this endpoint.
Secondary Outcomes (8)
Change in Serum Levels of Testosterone
Samples for testosterone analyses were obtained at baseline and at time of progression. In this study cohort, participants were followed up to 48 months for this endpoint.
Prostate-Specific Antigen (PSA) Response
PSA was measured at baseline and day 1 of every cycle on treatment. In this study cohort, participants were followed up to 48 months for this endpoint.
Time to PSA Progression
PSA was measured at baseline and day 1 of every cycle on treatment. In this study cohort, participants were followed up to 48 months for this endpoint.
Best Overall Response
Disease was evaluated radiologically at baseline and every 12 weeks cycles on treatment. In this study cohort, participants were followed up to 48 months for this endpoint.
Time to Progression (TTP)
Disease evaluation occurred every 12 weeks while patients were receiving treatment. In this study cohort, participants were followed up to 48 months for this endpoint.
- +3 more secondary outcomes
Study Arms (1)
Abiraterone+prednisone+dutasteride
EXPERIMENTALAbiraterone acetate 1000mg orally once per day + prednisone 5mg orally once per day for two months, followed by abiraterone 1000mg orally once per day + prednisone 5mg orally once per day + dutasteride 3.5mg orally once per day in 28-day cycles until symptomatic or radiographic progression
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of adenocarcinoma of the prostate
- Castrate resistant disease
- Metastatic disease
- Normal organ and marrow function
- Subjects with partners of childbearing potential must be willing to use adequate methods of birth control
You may not qualify if:
- Uncontrolled intercurrent illness
- Uncontrolled hypertension
- Active or symptomatic viral hepatitis or chronic liver disease
- History of pituitary or adrenal dysfunction
- Clinically significant heart disease
- History of a different malignancy unless disease-free for at least 5 years
- Known brain metastasis
- History of gastrointestinal disorders
- Prior therapy with abiraterone acetate
- HIV-positive individuals on antiretroviral therapy
- Requirement for steroid use greater than the equivalent of 5 mg of prednisone daily
- Atrial fibrillation or other cardiac arrhythmia requiring therapy
- Thromboembolism in the last 6 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
Related Publications (4)
McKay RR, Zukotynski KA, Werner L, Voznesensky O, Wu JS, Smith SE, Jiang Z, Melnick K, Yuan X, Kantoff PW, Montgomery B, Balk SP, Taplin ME. Imaging, procedural and clinical variables associated with tumor yield on bone biopsy in metastatic castration-resistant prostate cancer. Prostate Cancer Prostatic Dis. 2014 Dec;17(4):325-31. doi: 10.1038/pcan.2014.28. Epub 2014 Aug 5.
PMID: 25091040RESULTMcKay RR, Werner L, Mostaghel EA, Lis R, Voznesensky O, Zhang Z, Marck BT, Matsumoto AM, Domachevsky L, Zukotynski KA, Bhasin M, Bubley GJ, Montgomery B, Kantoff PW, Balk SP, Taplin ME. A Phase II Trial of Abiraterone Combined with Dutasteride for Men with Metastatic Castration-Resistant Prostate Cancer. Clin Cancer Res. 2017 Feb 15;23(4):935-945. doi: 10.1158/1078-0432.CCR-16-0987. Epub 2016 Sep 28.
PMID: 27683182RESULTChen EJ, Sowalsky AG, Gao S, Cai C, Voznesensky O, Schaefer R, Loda M, True LD, Ye H, Troncoso P, Lis RL, Kantoff PW, Montgomery RB, Nelson PS, Bubley GJ, Balk SP, Taplin ME. Abiraterone treatment in castration-resistant prostate cancer selects for progesterone responsive mutant androgen receptors. Clin Cancer Res. 2015 Mar 15;21(6):1273-80. doi: 10.1158/1078-0432.CCR-14-1220. Epub 2014 Oct 15.
PMID: 25320358RESULTWang Z, Deng T, Long X, Lin X, Wu S, Wang H, Ge R, Zhang Z, Wu CL, Taplin ME, Olumi AF. Methylation of SRD5A2 promoter predicts a better outcome for castration-resistant prostate cancer patients undergoing androgen deprivation therapy. PLoS One. 2020 Mar 5;15(3):e0229754. doi: 10.1371/journal.pone.0229754. eCollection 2020.
PMID: 32134978DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Mary-Ellen Taplin
- Organization
- Dana-Farber Cancer Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Mary-Ellen Taplin, M.D.
Dana-Farber Cancer Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor of Medicine, HMS
Study Record Dates
First Submitted
June 21, 2011
First Posted
July 13, 2011
Study Start
September 1, 2011
Primary Completion
January 1, 2016
Study Completion
March 15, 2017
Last Updated
March 15, 2018
Results First Posted
June 14, 2017
Record last verified: 2018-02
Data Sharing
- IPD Sharing
- Will not share
This will not be done.