Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

IMAAGEN: Impact of Abiraterone Acetate in Prostate-Specific Antigen

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Janssen Biotech, Inc.
ClinicalTrials.gov Identifier:
NCT01314118
First received: March 4, 2011
Last updated: October 21, 2014
Last verified: October 2014

March 4, 2011
October 21, 2014
May 2011
October 2014   (final data collection date for primary outcome measure)
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 ]
The proportion of patients with = 50% reduction in PSA after 6 cycles of treatment [ Time Frame: Approximately 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01314118 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
  • Testosterone over time [ Time Frame: Approximately 3 and 6 months ] [ 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 ]
  • Time to PSA (Prostate Specific Antigen) progression [ Time Frame: Approximately or an average of 24 months. PSA levels are measured throughout the study duration ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
IMAAGEN: Impact of Abiraterone Acetate in Prostate-Specific Antigen
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

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.

This is a Phase 2, prospective, multicenter, open-label, single-arm study of abiraterone acetate plus prednisone in men with non-metastatic, castration-resistant prostate cancer (CRPC) who have a rising PSA despite castrate levels of testosterone. The study consists of Screening Phase (up to 4 weeks), Core Study Treatment Phase (comprised of six 28-day cycles), Pre-metastatic Disease Follow-up Phase and an optional Post-metastatic Disease Follow-up Phase. Each treatment cycle will last 28 days. Participating subjects will receive study agents (Abiraterone acetate 1000 mg/day plus prednisone 5 mg/day, orally) continually during the study. Subjects who have not had radiographic confirmed disease progression after the Core Study Treatment Phase will continue the study treatment in the Pre-metastatic Disease Follow-up Phase. When disease progression is confirmed, subjects will have an option to continue the study treatment and are able to receive subsequent anti- cancer therapy as clinically needed in Post-metastatic Disease Follow-up Phase. The study will end when all participated subjects have disease progression. Subjects will be required to return to the study site 30 days after receiving the last dose of abiraterone acetate for safety follow-up.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Prostate Cancer
  • Prostatic Neoplasm
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.
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.
Intervention: Drug: abiraterone acetate in combination with prednisone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
133
July 2016
October 2014   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01314118
CR017932, Protocol 212082PCR2005
No
Janssen Biotech, Inc.
Janssen Biotech, Inc.
Not Provided
Study Director: Janssen Services, LLC. Clinical Trial Janssen Biotech, Inc.
Janssen Biotech, Inc.
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP