A Study of Abiraterone Acetate (JNJ-212082) and Prednisolone in Patients With Advanced Prostate Cancer

• ClinicalTrials.gov Identifier: NCT01685983
• Recruitment Status: Completed
• First Posted: September 17, 2012
• Results First Posted: May 23, 2016
• Last Update Posted: March 15, 2019
• Sponsor: Janssen Research & Development, LLC
• Information provided by (Responsible Party): Janssen Research & Development, LLC

Study Description

Brief Summary:

The purpose of this study is to assess the safety and efficacy in Korea or Taiwan of oral abiraterone acetate and oral prednisolone in men with metastatic-castration resistant prostate cancer (mCRPC) and with disease progression following treatment with a docetaxel-containing chemotherapy.

Condition or disease	Intervention/treatment	Phase
Prostate Cancer	Drug: Abiraterone acetate; Drug: Prednisolone	Phase 2

Detailed Description:

This is an open-label (all people know the identity of the intervention), multicenter, single arm (only one treatment group) study to evaluate the efficacy and safety of abiraterone acetate in patients with mCRPC. The study will be divided into screening phase (up to 28 days before enrollment), treatment phase including treatment cycles (each cycle of treatment will be 28 days), and follow-up phase. Approximately 80 patients will be enrolled into this study. Safety evaluations for adverse events, clinical laboratory tests, electrocardiogram and vital signs as well as pharmacokinetic (what the body does to drug) assessments will be conducted in this study. Patients will continue to receive abiraterone acetate plus prednisolone until disease progression or occurrence of unacceptable toxicity.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 82 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 2 Open Label Study of Abiraterone Acetate (JNJ-212082) and Prednisolone in Patients With Advanced Prostate Cancer Who Have Failed Androgen Deprivation and Docetaxel-Based Chemotherapy.
• Actual Study Start Date: August 30, 2011
• Actual Primary Completion Date: January 24, 2013
• Actual Study Completion Date: March 6, 2018

Arms and Interventions

Arm

Intervention/treatment

Experimental: Abiraterone actetate and Prednisolone

Drug: Abiraterone acetate; Type=exact number, unit=mg, number=250, form=tablet, route=oral. Patients will receive 4 tablets of abiraterone acetate at least 1 hour before a meal or 2 hours after a meal any time up to 10 pm every day.; Other Name: JNJ-212082; Drug: Prednisolone; Type=exact number, unit=mg, number=5, form=tablet, route=oral. Patients will receive 1 tablet of prednisolone twice daily.

Outcome Measures

Primary Outcome Measures :

1. Percentage of Participants With Prostate-specific Antigen (PSA) Response [ Time Frame: Baseline, Month 4 ]
   The PSA response was evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criterion, which is, greater than or equal to 50 percent decrease in PSA from Baseline during the study, which would be subsequently confirmed by a measurement that is at least 4 or more weeks after initial documentation of PSA response.

Secondary Outcome Measures :

1. Overall Survival [ Time Frame: Up to 3 Years ]
   Overall survival is defined as the time interval from the date of the first dose to the date of death due to any reason.
2. Time to PSA Progression [ Time Frame: Up to 28 Months ]
   Time to PSA progression was measured as the time interval from the date of the first dose to the date of PSA progression as defined in the protocol-specific PSAWG criteria. For participants who have achieved a greater than or equal to (>=) 50% decrease from the baseline PSA, assessment of time to disease progression is when the PSA has increased 50% above the nadir and at a minimum of 5 nanogram/mililiter (ng/mL). For participants without a PSA decrease of this magnitude or without a decrease, the time for progression is calculated at the time a 25% increase from baseline PSA has been achieved.
3. Percentage of Participants With Objective Radiographic Response [ Time Frame: Up to 3 Years ]
   Percentage of participants with radiographic objective response is defined as the percentage of participants with complete response (CR) or partial response (PR) as best overall response based on reconciled radiographic disease assessment according to RECIST Version 1.0. The CR is disappearance of all lesions. The PR is at least 30 percent decrease in sum of the longest diameter of target lesions or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.
4. Serum Testosterone [ Time Frame: Baseline and End-of-Treatment Visit (up to approximately 3 years) ]
   Median serum testosterone concentration was reported at baseline and End-of-Treatment visit.
5. Dehydroepiandrosterone Sulfate (DHEA-S) [ Time Frame: Baseline and End-of-Treatment Visit (up to approximately 3 years) ]
   Median DHEA-S concentration was reported at baseline and End-of-Treatment visit.
6. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to 3 Years ]
   An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Eligibility Criteria

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

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed adenocarcinoma of the prostate (stage IV)
• Has documented Prostate Specific Antigen (PSA) progression according to protocol-specific prostate specific antigen working group (PSAWG) eligibility criteria
• Has undergone prior chemotherapy for prostate cancer with regimen(s) containing Docetaxel
• Has an ongoing androgen deprivation with serum testosterone less than 50 ng/dL
• Has not received radiotherapy, chemotherapy, or immunotherapy at least 30 days prior to the treatment
• Eastern Cooperative Oncology Group Performance Status less than or equal to 2

Exclusion Criteria:

• Active or uncontrolled autoimmune disease that may require corticosteroid therapy
• Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
• Uncontrolled hypertension
• Hemoglobin less than or equal to 9.0 g/dL independent of transfusion
• Has abnormal liver function tests
• Surgery or local prostatic intervention within 30 days of the first dose

Contacts and Locations

Locations

Korea, Republic of

Busan, Korea, Republic of

Cheongju-Si, Korea, Republic of

Seongnam-Si, Gyeonggi-Do, Korea, Republic of

Seoul, Korea, Republic of

Taiwan

Kaohsiung, Taiwan

Taichung City, Taiwan

Taichung, Taiwan

Taipei, Taiwan

Taoyuan County, Taiwan

Sponsors and Collaborators

Janssen Research & Development, LLC

Investigators

• Study Director: Janssen Research & Development, LLC Clinical Trial; Janssen Research & Development, LLC

More Information

• Responsible Party: Janssen Research & Development, LLC
• ClinicalTrials.gov Identifier: NCT01685983
• Other Study ID Numbers: CR100009; 212082PCR2007 ( Other Identifier: Janssen Research & Development, LLC )
• First Posted: September 17, 2012
• Results First Posted: May 23, 2016
• Last Update Posted: March 15, 2019
• Last Verified: February 2019

• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Janssen Research & Development, LLC:

Prostate Cancer; Metastatic-castration resistant prostate cancer; Prostate specific antigen; Abiraterone acetate; JNJ-212082; Abiraterone; Prednisolone; Androgen Deprivation; Docetaxel-based chemotherapy

Additional relevant MeSH terms:

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Prostatic Diseases; Prednisolone; Abiraterone Acetate; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Antineoplastic Agents, Hormonal; Antineoplastic Agents; Steroid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Hormone Antagonists; Cytochrome P-450 Enzyme Inhibitors