Abiraterone With Different Steroid Regimens for Side Effect Related to Mineralcorticoid Excess Prevention in Prostate Cancer Prior to Chemotherapy
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ClinicalTrials.gov Identifier: NCT01867710 |
Recruitment Status
:
Active, not recruiting
First Posted
: June 4, 2013
Results First Posted
: May 11, 2016
Last Update Posted
: October 27, 2017
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Condition or disease | Intervention/treatment | 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 (Clinical Trial) |
Actual Enrollment : | 164 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Actual Study Start Date : | July 16, 2013 |
Actual Primary Completion Date : | April 20, 2015 |
Estimated Study Completion Date : | July 16, 2018 |

Arm | Intervention/treatment |
---|---|
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
|
- Percentage of Participants Experiencing Neither of the 2 Mineralocorticoid Excess Toxicity During the First 24 Weeks of Treatment [ Time Frame: Week 24 ]No mineralocorticoid excess is defined as experiencing neither of the 2 mineralocorticoid excess toxicities, that is, neither hypokalemia nor hypertension.
- Percentage of Participants With Confirmed Prostate Specific Antigen (PSA) Response Rate [Greater Than or Equal to (>=) 50 Percent (%) Decline From Baseline] at Week 12 [ Time Frame: Week 12 ]The PSA response is defined as a >= 50% decline from baseline according to the adapted Prostate Cancer Working Group 2 (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.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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

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): NCT01867710
Belgium | |
Aalst, Belgium | |
Brussels, Belgium | |
Gent, Belgium | |
Hasselt, Belgium | |
Kortrijk, Belgium | |
Leuven, Belgium | |
Germany | |
Hannover, Germany | |
Mülheim, Germany | |
Nürtingen, Germany | |
Tübingen, Germany | |
Hungary | |
Budapest, Hungary | |
Miskolc, Hungary | |
United Kingdom | |
Birmingham, United Kingdom | |
Glasgow, United Kingdom | |
London, United Kingdom | |
Sutton, United Kingdom | |
Whitchurch, United Kingdom |
Responsible Party: | Janssen Pharmaceutica N.V., Belgium |
ClinicalTrials.gov Identifier: | NCT01867710 History of Changes |
Other Study ID Numbers: |
CR100916 2012-004331-23 ( EudraCT Number ) 212082PCR2023 ( Other Identifier: Janssen CTMS ID ) |
First Posted: | June 4, 2013 Key Record Dates |
Results First Posted: | May 11, 2016 |
Last Update Posted: | October 27, 2017 |
Last Verified: | September 2017 |
Studies a U.S. FDA-regulated Device Product: | No |
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 Hyperaldosteronism Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Adrenocortical Hyperfunction Adrenal Gland Diseases Endocrine System Diseases Dexamethasone acetate Dexamethasone Prednisone Abiraterone Acetate |
BB 1101 Mineralocorticoids Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors Enzyme Inhibitors |