An Observational Study of Continuous Oral Dosing of Abiraterone Acetate in Castration-Resistant Prostate Cancer Patients Evaluating Androgens and Steroid Metabolites in Bone Marrow Plasma

July 3, 2014 updated by: Janssen Research & Development, LLC

An Observational Study of Continuous Oral Dosing of an Irreversible CYP17 Inhibitor, Abiraterone Acetate (CB7630), in Castration-Resistant Prostate Cancer Patients Evaluating Androgens and Steroid Metabolites in Bone Marrow Plasma

The purpose of this study is to investigate the effect of abiraterone acetate on levels of androgens and steroid metabolites in bone marrow plasma of patients with metastatic castration-resistant prostate cancer (CRPC).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a single-center, open-label (identity of assigned study drug will be known) study investigating the effect of abiraterone acetate on levels of testosterone and dihydrotestosterone (DHT) in bone marrow plasma of patients with metastatic CRPC and evaluating the difference in bone marrow androgen levels between patients with and without serum prostate specific antigen (PSA) decline. Approximately 60 medically or surgically castrated male patients with metastatic CRPC will be enrolled. The study will consist of screening, treatment, and follow-up periods. Patients will be treated orally (by mouth) with abiraterone acetate 1000 mg daily and prednisone 5 mg twice a day until clinical disease progression. Follow-up will continue until the patient dies, is lost to follow-up or withdraws informed consent. Bone marrow aspirates will be collected at Week 1 (predose), Week 9, and the final study visit. Safety will be monitored throughout the study.

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Histologically proven adenocarcinoma of the prostate
  • Eastern Cooperative Oncology Group (ECOG) performance status <=2 (Karnofsky Performance Status >=50%)
  • Serum testosterone levels <50ng/ml
  • Ongoing gonadal androgen deprivation therapy with luteinizing hormone-releasing hormone (LHRH) analogues or orchiectomy (patients, who have not had an orchiectomy, must be maintained on effective LHRH analogue therapy for the duration of the study)
  • Progression of disease despite androgen ablation (either documented osseous or soft tissue metastatic disease progression or by prostate specific antigen [PSA] criteria progression)
  • Progressive disease is defined by PSA evidence (PSA level of at least 5 ng/ml which has risen on at least 2 successive occasions, at least 2 weeks apart)
  • Presence of metastatic bone disease
  • Discontinue diethylstilbestrol or steroids treatment for >=4 weeks and for antiandrogens >6 weeks
  • Antiandrogen withdrawal: patients who are receiving an antiandrogen as part of primary androgen ablation must demonstrate disease progression following discontinuation of antiandrogen (disease progression after antiandrogen withdrawal is defined as 2 consecutive rising PSA values, obtained at least 2 weeks apart, or documented osseous or soft tissue progression)
  • For patients receiving flutamide, at least one of the PSA values must be obtained 4 weeks or more after flutamide discontinuation
  • For patients receiving bicalutamide or nilutamide, at least one of the PSA values must be obtained 6 weeks or more after antiandrogen discontinuation
  • Adequate adrenal function
  • Laboratory values within protocol -defined parameters
  • No evidence of chronic or acute disseminated intravascular coagulation or bleeding tendency and no angina at rest
  • Agrees to protocol-defined use of effective contraception

Exclusion Criteria:

  • Histologic variants other than adenocarcinoma in the primary tumor
  • More then 2 different prior chemotherapeutic regimens for metastatic prostate cancer
  • Abnormal liver function
  • Therapy with other hormonal therapy, including any dose of megestrol acetate (Megace), Ketoconazole, finasteride (Proscar), dutasteride (Avodart) any herbal product known to decrease PSA levels (eg, Saw Palmetto and PC-SPES), or any systemic corticosteroid within 4 weeks prior to first dose of study drug
  • Active infection or intercurrent illness that are not controlled
  • Unstable angina, myocardial infarction within the previous 6 months, or use of ongoing maintenance therapy for life-threatening ventricular arrhythmia, uncontrolled hypertension, New York Heart Association (NYHA) Class III or IV congestive heart failure
  • Prior radiation therapy completed <4 weeks or single fraction of palliative radiotherapy within 14 days prior to first dose of study drug
  • Any currently active second malignancy, other than non-melanoma skin cancer
  • Active psychiatric illnesses/social situations that would limit compliance with protocol requirements
  • Active or uncontrolled autoimmune disease that may require corticosteroid therapy during study
  • Severely compromised immunological state, including being positive for the human immunodeficiency virus (HIV)
  • Acute or chronic hepatitis B or C
  • Initiation of bisphosphonate therapy within 4 weeks prior to first dose of study drug
  • Long QT syndrome or bundle branch block or hemiblock or other history of life-threatening arrhythmia (unless the patient has been effectively treated for it and is considered stable)
  • Known brain metastasis
  • History of pituitary or adrenal dysfunction
  • History of gastrointestinal disorders (medical disorders or extensive surgery) which may interfere with the absorption of the study drug
  • Prior therapy with abiraterone acetate
  • Any acute toxicities due to prior chemotherapy and/or radiotherapy that have not resolved to a NCI CTCAE (version 3) grade of <=1
  • Condition or situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Abiraterone acetate plus prednisone
Patients will be treated orally with abiraterone acetate 1000 mg daily and prednisone 5 mg twice a day until clinical disease progression.
Drug: Abiraterone acetate
Abiraterone 1000 mg (4 x 250 mg tablets) taken orally once daily
Drug: Prednisone
Prednisone 5 mg tablet taken orally twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Detectable Bone Marrow Testosterone Level (>1 Picograms/Mililiter)
Time Frame: Baseline (predose Week 1 Day 1) and Week 8
Baseline (predose Week 1 Day 1) and Week 8
Number of Participants With Detectable Bone Marrow Dihydrotestosterone (DHT) Level (>9 Picograms/Mililiter)
Time Frame: Baseline (predose Week 1 Day 1) and Week 8
Baseline (predose Week 1 Day 1) and Week 8
Difference in Bone Marrow Testosterone Levels Between Participants With and Without Serum Prostate Specific Antigen Decline
Time Frame: Week 8
Week 8

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Change in Markers of Bone Metabolism
Time Frame: Week 8
Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Research & Development, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

October 15, 2007

First Submitted That Met QC Criteria

October 15, 2007

First Posted (Estimate)

October 16, 2007

Study Record Updates

Last Update Posted (Estimate)

July 17, 2014

Last Update Submitted That Met QC Criteria

July 3, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR016906
  • COU-AA-BMA (Other Identifier: Janssen Research & Development, LLC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prostate Neoplasms

Clinical Trials on Abiraterone acetate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Latvia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe