Abiraterone With Different Steroid Regimens for Side Effect Related to Mineralcorticoid Excess Prevention in Prostate Cancer Prior to Chemotherapy
A Randomized Phase 2 Study Evaluating Abiraterone Acetate With Different Steroid Regimens for Preventing Symptoms Associated With Mineralocorticoid Excess in Asymptomatic, Chemotherapy-naïve and Metastatic Castration-resistant Prostate Cancer (mCRPC) Patients
3 other identifiers
interventional
164
4 countries
17
Brief Summary
The purpose of the study is to determine the safety and clinical benefit of the combinations of abiraterone acetate and prednisone or abiraterone and dexamethasone in prostate cancer patients. Prednisone will be given at one of three different dose schedules. Dexamethasone will be given at one dose schedule. This will include looking at what side effects occur and how often they occur. In addition the impact of the study drug on quality of life and pain will be evaluated. The study will also collect data on subsequent treatment of patients after they come off the study drug (approximately 4.5 years after the start of study treatment of the first subject participating in the study). By analyzing blood samples, the study aims to identify if some markers could help to understand if the treatment with abiraterone is effective and also help to understand if patients can become resistant.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 prostate-cancer
Started Jul 2013
Typical duration for phase_2 prostate-cancer
17 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
May 30, 2013
CompletedFirst Posted
Study publicly available on registry
June 4, 2013
CompletedStudy Start
First participant enrolled
July 16, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 20, 2015
CompletedResults Posted
Study results publicly available
May 11, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 5, 2018
CompletedJuly 5, 2019
July 1, 2019
1.8 years
May 30, 2013
April 6, 2016
July 2, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Experiencing Neither of the 2 Mineralocorticoid Excess Toxicity During the First 24 Weeks of Treatment
No mineralocorticoid excess is defined as experiencing neither of the 2 mineralocorticoid excess toxicities, that is, neither hypokalemia nor hypertension.
Week 24
Secondary Outcomes (14)
Percentage of Participants With Confirmed Prostate Specific Antigen (PSA) Response Rate [Greater Than or Equal to (>=) 50 Percent (%) Decline From Baseline] at Week 12
Week 12
Change From Baseline to Endpoint in Brief Pain Inventory- Short Form (BPI-SF) Score: Worst Pain
Baseline up to the Endpoint (last post-baseline assessment value during 156 weeks of main study treatment period [MSTP])
Change From Baseline to Endpoint in Brief Pain Inventory- Short Form (BPI-SF) Score: Pain Intensity Subscale
Baseline up to the Endpoint (last post-baseline assessment value during 156 weeks of MSTP)
Change From Baseline to Endpoint in Brief Pain Inventory- Short Form (BPI-SF) Score: Pain Interference Subscale
Baseline up to the Endpoint (last post-baseline assessment value during 156 weeks of MSTP)
Change From Baseline to Endpoint in EuroQol-5 Dimension-5 Level (EQ-5D-5L): Index Score
Baseline up to the Endpoint (last post-baseline assessment value during 156 weeks of MSTP)
- +9 more secondary outcomes
Study Arms (4)
AA + prednisone 5 mg twice daily
EXPERIMENTALAbiraterone acetate in combination with prednisone 5 mg twice daily
AA + prednisone 5 mg once daily
EXPERIMENTALAbiraterone acetate in combination with prednisone 5 mg once daily dose
AA + prednisone 2.5 mg twice daily
EXPERIMENTALAbiraterone acetate in combination with prednisone 2.5 mg twice daily
AA + dexamethasone 0.5 mg once daily
EXPERIMENTALAbiraterone acetate in combination with dexamethasone 0.5 mg once daily
Interventions
Type = exact number; unit = mg; number = 1000; form = tablet; route = oral; taken as four 250 mg tablets once daily at least 2 hours after eating and no food should be eaten for at least 1 hour after taking the tablets.
type = exact number; unit = mg; number = 5; form = tablet; route = oral; taken twice daily, the first dose in the morning after a meal and the second dose after a minimum interval of 8 hours in the late afternoon or early evening, after a meal
type = exact number; unit = mg; number = 5; form = tablet; route = oral; taken once daily, in the morning after a meal
type = exact number; unit = mg; number = 2.5; form = tablet; route = oral; taken twice daily, the first dose in the morning after a meal and the second dose after a minimum interval of 8 hours in the late afternoon or early evening, after a meal
type = exact number; unit = mg; number = 0.5; form = tablet; route = oral; taken once daily, in the morning after breakfast
Eligibility Criteria
You may qualify if:
- Have a histologically or cytologically confirmed adenocarcinoma of the prostate Have metastatic disease documented by positive bone scan or by computed tomography or magnetic resonance imaging Have prostate cancer progression documented by prostate specific antigen according to Prostate Cancer Working Group 2 or radiographic progression according to modified RECIST (response evaluation criteria in solid tumors, v1.1) criteria Be asymptomatic from prostate cancer. A score of 0-1 on BPI-SF Question #3 (worst pain in last 24 hours) will be considered asymptomatic Be surgically or medically castrated, with testosterone levels of \<50 ng/dL (\<2.0 nmol/L). If the subject is being treated with luteinizing hormone releasing hormone (LHRH) agonists or antagonists (subjects who have not undergone orchiectomy), this therapy must have been initiated at least 4 weeks prior to Day 1, Cycle 1 and must be continued throughout the study.
You may not qualify if:
- Has a history of pituitary or adrenal dysfunction Has an active infection or other medical condition that would contraindicate corticosteroid use Has any chronic medical condition requiring corticosteroid treatment or has received prior corticosteroid treatment for prostate cancer Has a pathological finding consistent with small cell carcinoma of the prostate Has a known brain metastasis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Unknown Facility
Aalst, Belgium
Unknown Facility
Brussels, Belgium
Unknown Facility
Ghent, Belgium
Unknown Facility
Hasselt, Belgium
Unknown Facility
Kortrijk, Belgium
Unknown Facility
Leuven, Belgium
Unknown Facility
Hanover, Germany
Unknown Facility
Mülheim, Germany
Unknown Facility
Nürtingen, Germany
Unknown Facility
Tübingen, Germany
Unknown Facility
Budapest, Hungary
Unknown Facility
Miskolc, Hungary
Unknown Facility
Birmingham, United Kingdom
Unknown Facility
Glasgow, United Kingdom
Unknown Facility
London, United Kingdom
Unknown Facility
Sutton, United Kingdom
Unknown Facility
Whitchurch, United Kingdom
Related Publications (3)
Jayaram A, Wingate A, Wetterskog D, Wheeler G, Sternberg CN, Jones R, Berruti A, Lefresne F, Lahaye M, Thomas S, Gormley M, Meacham F, Garg K, Lim LP, Merseburger AS, Tombal B, Ricci D, Attard G. Plasma tumor gene conversions after one cycle abiraterone acetate for metastatic castration-resistant prostate cancer: a biomarker analysis of a multicenter international trial. Ann Oncol. 2021 Jun;32(6):726-735. doi: 10.1016/j.annonc.2021.03.196. Epub 2021 Mar 29.
PMID: 33794293DERIVEDJayaram A, Wingate A, Wetterskog D, Conteduca V, Khalaf D, Sharabiani MTA, Calabro F, Barwell L, Feyerabend S, Grande E, Martinez-Carrasco A, Font A, Berruti A, Sternberg CN, Jones R, Lefresne F, Lahaye M, Thomas S, Joshi S, Shen D, Ricci D, Gormley M, Merseburger AS, Tombal B, Annala M, Chi KN, De Giorgi U, Gonzalez-Billalabeitia E, Wyatt AW, Attard G. Plasma Androgen Receptor Copy Number Status at Emergence of Metastatic Castration-Resistant Prostate Cancer: A Pooled Multicohort Analysis. JCO Precis Oncol. 2019 Sep 24;3:PO.19.00123. doi: 10.1200/PO.19.00123. eCollection 2019.
PMID: 32923850DERIVEDAttard G, Merseburger AS, Arlt W, Sternberg CN, Feyerabend S, Berruti A, Joniau S, Geczi L, Lefresne F, Lahaye M, Shelby FN, Pissart G, Chua S, Jones RJ, Tombal B. Assessment of the Safety of Glucocorticoid Regimens in Combination With Abiraterone Acetate for Metastatic Castration-Resistant Prostate Cancer: A Randomized, Open-label Phase 2 Study. JAMA Oncol. 2019 Aug 1;5(8):1159-1167. doi: 10.1001/jamaoncol.2019.1011.
PMID: 31246234DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Study not designed/powered to allow comparisons in study groups. Per protocol amendment 6, the study was ended earlier since sufficient extension and follow-up data have been collected to allow statistical analysis of secondary objectives.
Results Point of Contact
- Title
- Medical Affairs Director
- Organization
- Janssen Pharmaceutica N.V
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 30, 2013
First Posted
June 4, 2013
Study Start
July 16, 2013
Primary Completion
April 20, 2015
Study Completion
June 5, 2018
Last Updated
July 5, 2019
Results First Posted
May 11, 2016
Record last verified: 2019-07