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

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:

MedlinePlus related topics: Cancer Prostate Cancer Steroids

Drug Information available for: Dexamethasone Prednisone Dexamethasone sodium phosphate Dexamethasone acetate Abiraterone acetate

U.S. FDA Resources

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:	June 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

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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
	Active, not recruiting
Hannover, Germany
	Recruiting
Mülheim, Germany
	Active, not recruiting
Nürtingen, Germany
	Active, not recruiting
Tübingen, Germany
Hungary
	Active, not recruiting
Budapest, Hungary
	Active, not recruiting
Miskolc, 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:

To learn how to participate in this trial please click here. This link exits the ClinicalTrials.gov site

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:	February 10, 2015
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 Diseases, Male Genital Neoplasms, Male Neoplasms Neoplasms by Site Prostatic Diseases Urogenital Neoplasms BB 1101 Dexamethasone Dexamethasone 21-phosphate Dexamethasone acetate Mineralocorticoids Prednisone Anti-Inflammatory Agents Antiemetics	Antineoplastic Agents Antineoplastic Agents, Hormonal Autonomic Agents Central Nervous System Agents Enzyme Inhibitors Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Molecular Mechanisms of Pharmacological Action Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Protease Inhibitors Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015