Abiraterone With Different Steroid Regimens for Side Effect Related to Mineralcorticoid Excess Prevention in Prostate Cancer Prior to Chemotherapy

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Janssen Pharmaceutica N.V., Belgium
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutica N.V., Belgium
ClinicalTrials.gov Identifier:
NCT01867710
First received: May 30, 2013
Last updated: August 15, 2014
Last verified: August 2014
  Purpose

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 (up to a maximum of 5 years after the study starts). 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.


Condition Intervention Phase
Prostate Cancer
Drug: Abiraterone Acetate
Drug: Prednisone 5 mg twice daily
Drug: Prednisone 5 mg once daily
Drug: Prednisone 2.5 mg twice daily
Drug: Dexamethasone 0.5 mg once daily
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Janssen Pharmaceutica N.V., Belgium:

Primary Outcome Measures:
  • Number of participants experiencing neither hypokalemia nor hypertension treatment-emergent adverse events up to Week 24 [ Time Frame: up to 24 Weeks after Day 1 of Cycle 1 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Progression Free Survival [ Time Frame: up to 5 years after the start of study treatment of the first patient in the study ] [ Designated as safety issue: No ]
    time from randomization to the occurrence of one of the following: radiographic progression, clinical progression or death

  • Prostate specific antigen response rate [ Time Frame: up to 5 years after the start of study treatment of the first patient in the study ] [ Designated as safety issue: No ]
    A PSA response is defined as a ≥50% decline from baseline according to the adapted PCWG2 criteria. For a PSA response to be confirmed, an additional PSA measurement obtained 4 or more weeks later has to show ≥50% decline from baseline.

  • Time to prostate specific antigen progression [ Time Frame: up to 5 years after the start of study treatment of the first patient in the study ] [ Designated as safety issue: No ]
  • Objective response rate [ Time Frame: up to 5 years after the start of study treatment of the first patient in the study ] [ Designated as safety issue: No ]
  • Time to opiate use for cancer pain [ Time Frame: up to end of main study visit at the end of Cycle 39 (156 weeks) ] [ Designated as safety issue: No ]
  • Time to deterioration in Eastern Cooperative Oncology Group (ECOG) performance score by 1 point [ Time Frame: up to end of main study visit at the end of Cycle 39 (156 weeks) ] [ Designated as safety issue: No ]
  • Number of participants with change in EQ-5D-5L score [ Time Frame: Day 1 of Cycles 1, 6, 18, 39 or at end of main study treatment assessment for participants discontinuing study treatment Cycle 39 ] [ Designated as safety issue: No ]
  • Number of participants with change in Brief Pain Inventory - short form (BPI-SF) score [ Time Frame: Screening; Day 1 of Cycles 1, 6, 18, 39 or at end of main study treatment assessment for participants discontinuing study treatment Cycle 39 ] [ Designated as safety issue: No ]
  • Number of participants with change in Functional Assessment of Cancer Therapy - Prostate Cancer (FACT-P) score [ Time Frame: Day 1 of Cycles 1, 6, 18, 39 or at end of main study treatment assessment for participants discontinuing study treatment Cycle 39 ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: up to 5 years after the start of study treatment of the first patient in the study ] [ Designated as safety issue: No ]
  • Time to next therapy for prostate cancer [ Time Frame: up to 5 years after the start of study treatment of the first patient in the study ] [ Designated as safety issue: No ]
  • Time to initiation of subsequent chemotherapy [ Time Frame: up to 5 years after the start of study treatment of the first patient in the study ] [ Designated as safety issue: No ]
  • Treatment duration of subsequent chemotherapy [ Time Frame: up to 5 years after the start of study treatment of the first patient in the study ] [ Designated as safety issue: No ]

Estimated Enrollment: 144
Study Start Date: July 2013
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AA + prednisone 5 mg twice daily
Abiraterone acetate in combination with prednisone 5 mg twice daily
Drug: Abiraterone Acetate
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.
Drug: Prednisone 5 mg twice daily
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
Experimental: AA + prednisone 5 mg once daily
Abiraterone acetate in combination with prednisone 5 mg once daily dose
Drug: Abiraterone Acetate
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.
Drug: Prednisone 5 mg once daily
type = exact number; unit = mg; number = 5; form = tablet; route = oral; taken once daily, in the morning after a meal
Experimental: AA + prednisone 2.5 mg twice daily
Abiraterone acetate in combination with prednisone 2.5 mg twice daily
Drug: Abiraterone Acetate
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.
Drug: Prednisone 2.5 mg twice daily
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
Experimental: AA + dexamethasone 0.5 mg once daily
Abiraterone acetate in combination with dexamethasone 0.5 mg once daily
Drug: Abiraterone Acetate
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.
Drug: Dexamethasone 0.5 mg once daily
type = exact number; unit = mg; number = 0.5; form = tablet; route = oral; taken once daily, in the morning after breakfast

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01867710

Contacts
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: JNJ.CT@sylogent.com

Locations
Belgium
Recruiting
Aalst, Belgium
Recruiting
Brussels, Belgium
Recruiting
Gent, Belgium
Recruiting
Hasselt, Belgium
Recruiting
Kortrijk, Belgium
Recruiting
Leuven, Belgium
Germany
Withdrawn
Aachen, Germany
Recruiting
Hannover, Germany
Recruiting
Mülheim, Germany
Recruiting
Nürtingen, Germany
Recruiting
Tübingen, Germany
Hungary
Recruiting
Budapest, Hungary
United Kingdom
Recruiting
Birmingham, United Kingdom
Withdrawn
Dundee, United Kingdom
Recruiting
Glasgow, United Kingdom
Recruiting
London, United Kingdom
Recruiting
Sutton, United Kingdom
Recruiting
Whitchurch, United Kingdom
Sponsors and Collaborators
Janssen Pharmaceutica N.V., Belgium
  More Information

Additional Information:
No publications provided

Responsible Party: Janssen Pharmaceutica N.V., Belgium
ClinicalTrials.gov Identifier: NCT01867710     History of Changes
Other Study ID Numbers: CR100916, 2012-004331-23, 212082PCR2023
Study First Received: May 30, 2013
Last Updated: August 15, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Germany: Ethics Commission
Great Britain: Medicines and Healthcare Products Regulatory Agency
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines

Keywords provided by Janssen Pharmaceutica N.V., Belgium:
Mineralocorticoid Excess ; Chemotherapy-Naïve; Metastatic Castration-Resistant Prostate Cancer; Abiraterone Acetate; Zytiga; Prednisone; dexamethasone

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Dexamethasone acetate
Dexamethasone
Prednisone
Dexamethasone 21-phosphate
BB 1101
Mineralocorticoids
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 25, 2014