Overview

This trial is active, not recruiting.

Conditions prostate cancer, prostatic neoplasm
Treatment abiraterone acetate in combination with prednisone
Phase phase 2
Sponsor Janssen Biotech, Inc.
Start date May 2011
End date December 2013
Trial size 131 participants
Trial identifier NCT01314118, CR017932, Protocol 212082PCR2005

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
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.

Primary Outcomes

Measure
Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in Prostate-Specific Antigen (PSA) During the Core Study
time frame: End of core study visit (Approximately at Month 6)

Secondary Outcomes

Measure
Time to Radiographic Evidence of Disease Progression (TTRP)
time frame: Maximum up to Month 30.5
Time to Prostate-Specific Antigen (PSA) Progression
time frame: Maximum up to Month 30.5
Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in Prostate-Specific Antigen (PSA) Levels After 3 Cycles of Treatment
time frame: End of Cycle 3 (Approximately Month 3)

Eligibility Criteria

Male participants at least 18 years old.

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

Additional Information

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
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Janssen Biotech, Inc..