IMAAGEN: Impact of Abiraterone Acetate in Prostate-Specific Antigen - Full Text View

Sponsor:	Janssen Biotech, Inc.
Information provided by:	Janssen Biotech, Inc.
ClinicalTrials.gov Identifier:	NCT01314118

Purpose

The purpose of this study is to show that abiraterone acetate plus prednisone added to the current standard of care, gonadotropin-releasing hormone (GnRH) decreases prostate specific antigen (PSA) and prolongs the time until it is evident that the cancer has grown. Additionally, safety information about abiraterone acetate in combination with prednisone will be collected. This will include looking at what side effects occur, how often they occur, and for how long they last.

Condition	Intervention	Phase
Prostate Cancer Prostatic Neoplasm	Drug: abiraterone acetate in combination with prednisone	Phase 2

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Multicenter, Open-label, Single-arm, Phase 2 Study of Abiraterone Acetate Plus Prednisone in Subjects With Advanced Prostate Cancer Without Radiographic Evidence of Metastatic Disease

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Prednisone Abiraterone acetate

U.S. FDA Resources

Further study details as provided by Janssen Biotech, Inc.:

Primary Outcome Measures:

The proportion of patients with >= 50% reduction in PSA after 6 cycles of treatment or by the End of Core Study Visit [ Time Frame: Approximately 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The proportion of subjects with a >= 50% reduction in PSA levels after 3 cycles of treatment and absolute PSA reduction [ Time Frame: Approximately 3 months ] [ Designated as safety issue: No ]
The proportion of subjects with evidence of radiographic disease progression over time [ Time Frame: Approximately or an average of 24 months. Disease progression is measured throughout the study duration ] [ Designated as safety issue: No ]
Time to radiographic evidence of disease progression [ Time Frame: Approximately or an average of 24 months. Disease progression is measured throughout the study duration ] [ Designated as safety issue: No ]

Estimated Enrollment:	125
Study Start Date:	February 2011
Estimated Study Completion Date:	September 2014
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 001 abiraterone acetate in combination with prednisone Abiraterone acetate will be taken as 4 x 250 mg tablets by mouth (PO) once daily. Prednisone will be taken as 2 x 2.5 mg tablets PO once daily.	Drug: abiraterone acetate in combination with prednisone Abiraterone acetate will be taken as 4 x 250 mg tablets by mouth (PO) once daily. Prednisone will be taken as 2 x 2.5 mg tablets PO once daily.

Detailed Description:

This is a Phase 2, prospective, multicenter, open-label (both the patient and investigator will know what treatment is taken), single-arm study of abiraterone acetate plus prednisone in patients with non-metastatic (has not spread in the body), castration-resistant prostate cancer (CRPC) who have a rising PSA despite castrate levels of testosterone. This study has 4 phases: Screening Phase (up to 28 Days); Core Study Treatment Phase (Treatment-Cycle 1-6); Follow-up Phase (Treatment-Cycle 7- until disease progression); and an Extension Phase (after the end of the official study). Each treatment cycle will last 28 days (about a month). Your participation in the study will include a screening period of up to 28 days, which allows the doctor to assess whether or not you qualify for the study. There is a Core Treatment Phase where study medication is taken for six treatment cycles (about 6 months). There is a Follow-up Phase where study medication will continue to be taken until your prostate cancer progresses, or you have unacceptable toxicities or this phase of the study ends (approximately 18 months). If your prostate cancer progresses before the end of the follow-up phase, you will not be given further study medication. However, the study doctor will contact you about every 2 months to record any new therapy for prostate cancer you are taking until the end of the follow-up phase. If for some reason you stop study medication before the end of the follow-up phase, the study doctor will contact you about every 2 months to record any new therapy for prostate cancer you are taking until the end of the follow-up phase or until your prostate cancer progresses, whichever happens first. You will be required to return to the study site 30 days after receiving your last dose of abiraterone acetate for safety follow-up. You may be in the study for about 24 months. Four abiraterone acetate tablets should be taken by mouth [PO] at least 2 hours after eating & no food should be eaten for at least 1 hour afterward. Two (2.5 mg) prednisone tablets will be taken PO once daily, preferably with food. Patients may continue abiraterone acetate until disease progression, until unacceptable toxicities develop, until abiraterone acetate becomes commercially available for the indication being studied, or until the sponsor determines it is necessary to stop the study.

Eligibility

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

Criteria

Major Inclusion Criteria:

Be a male >= 18 years of age
Have adenocarcinoma of the prostate
Currently receiving continuous treatment with Gonadotropin-releasing hormone (GnRH) monotherapy for at least 6 months before or have undergone surgical removal of the testicles
Serum testosterone of < 50 ng/dL(< 2.0 nM)
Have rising PSA defined as a PSA of ≥ 10 ng/mL obtained at screening or PSADT of ≤ 10 months with the first of the 3 consecutive PSA values used to calculate PSADT ≥ 2.0 ng/mL
Have an Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
Be capable of swallowing study agents whole as a tablet
Be willing/able to adhere to the prohibitions and restrictions specified in this protocol

Major Exclusion Criteria:

Have prior or current evidence of local disease progression or metastatic disease as defined by modified response evaluation criteria in solid tumors (RECIST) criteria
Have received chemotherapy for treatment of castrate-resistant prostate cancer; however, if a patient received chemotherapy in an adjuvant setting, prior to having CRPC, for castrate-sensitive prostate cancer, the patient is still eligible
Are currently receiving any antiandrogen therapy (eg, bicalutamide, flutamide, or nilutamide).
If previously treated with antiandrogen therapy, there must be documentation of at least 2 consecutive rising PSA values at least 2 weeks apart obtained prior to screening
If previously treated with flutamide, at least 1 of the PSA values must be obtained 4 weeks or more after flutamide discontinuation.
If previously treated with bicalutamide or nilutamide, at least 1 of the PSA values must be obtained 6 weeks or more after antiandrogen discontinuation
Have previously received agents having any CYP17 inhibitory activity for the treatment of prostate cancer, such as ketoconazole
Have previously received aminoglutethimide
Have an active infection or other medical condition that would contraindicate prednisone use
Have uncontrolled hypertension
Have active hepatitis or chronic liver disease
Have clinically significant heart disease
Have poorly controlled diabetes
Have received an investigational therapeutic within 30 days of screening
Have partners of childbearing potential and are not willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator and sponsor during the study and for 1 week after last dose of abiraterone acetate.
Individuals with a history of a non-prostate malignancy are ineligible for this study with the following exceptions. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 3 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 3 years: basal cell or squamous cell carcinoma of the skin

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01314118

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

Show 50 Study Locations

Sponsors and Collaborators

Janssen Biotech, Inc.

Investigators

Study Director:

Janssen Services, LLC. Clinical Trial

Janssen Biotech, Inc.

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:	Senior Director, Medical Affairs Oncology, Janssen Biotech Inc.
ClinicalTrials.gov Identifier:	NCT01314118 History of Changes
Other Study ID Numbers:	CR017932, Protocol 212082PCR2005
Study First Received:	March 4, 2011
Last Updated:	May 18, 2012
Health Authority:	United States: Food and Drug Administration United States: Federal Government

Keywords provided by Janssen Biotech, Inc.:

abiraterone acetate
prednisone
zytiga

Additional relevant MeSH terms:

Neoplasms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Prednisone
Glucocorticoids

Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 23, 2012