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Corticosteroid

Abiraterone + Prednisone for Prostate Cancer

Phase 2

Waitlist Available

Research Sponsored by Janssen Biotech, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up maximum up to month 30.5

Awards & highlights

Study Summary

This trial will investigate whether adding abiraterone acetate + prednisone to the current standard of care (GnRH) can prolong the time until cancer growth is evident, as well as collecting safety information about this combination therapy.

Who is the study for?

Men over 18 with prostate cancer, currently on GnRH therapy or who've had testicular surgery, can join. They need a rising PSA level and must be able to swallow pills. Excluded are those with recent antiandrogen therapy, active hepatitis/liver disease, other cancers (except certain skin cancers), heart issues, uncontrolled diabetes/hypertension, or prior treatments affecting CYP17 enzyme.Check my eligibility

What is being tested?

The trial tests if adding abiraterone acetate plus prednisone to standard care lowers PSA levels and delays cancer growth in men with prostate cancer already receiving GnRH therapy or post-testicular removal.See study design

What are the potential side effects?

Possible side effects of abiraterone acetate combined with prednisone include liver problems, fatigue, joint swelling/pain, hot flushes, diarrhea and indigestion. The frequency and duration of these side effects will be monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself and am up and about more than half of my waking hours.

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I can swallow pills whole.

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I have been diagnosed with prostate adenocarcinoma.

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I am a man aged 18 or older.

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I have been on GnRH therapy for 6+ months or had my testicles removed.

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My PSA is rising and meets specific levels or speed of increase.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ maximum up to month 30.5

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~maximum up to month 30.5

This trial's timeline: 3 weeks for screening, Varies for treatment, and maximum up to month 30.5 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in Prostate-Specific Antigen (PSA) During the Core Study

Secondary outcome measures

Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in Prostate-Specific Antigen (PSA) Levels After 3 Cycles of Treatment

Time to Prostate-Specific Antigen (PSA) Progression

Time to Radiographic Evidence of Disease Progression (TTRP)

Trial Design

1Treatment groups

Experimental Treatment

Group I: 001Experimental Treatment1 Intervention

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.

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Janssen Biotech, Inc.Lead Sponsor

29 Previous Clinical Trials

18,678 Total Patients Enrolled

Janssen Services, LLC. Clinical TrialStudy DirectorJanssen Biotech, Inc.

Media Library

Prostate Cancer Research Study Groups: 001

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who meets the screening criteria for participation in this research?

"This trial is looking for 131 participants with prostate cancer between the ages of 18 and 99. To be eligible, candidates must meet the following criteria: 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, Serum testosterone of < 50 ng/dL(< 2.0 nM), ECOG performance status less than or equal to 2, Be a male >= 18 years of age, Have adenocarcinoma of the prostate, Currently receiving continuous treatment with Gon"

Answered by AI

Are there many research centers testing this medication in Canada?

"45 sites are running this clinical trial, with locations in Huntsville, Orange City, San Diego and 42 other cities. To limit travel requirements, patients should try to enroll at the location nearest them."

Answered by AI

Are they still enrolling individuals for this research project?

"As of right now, this study is not looking for any more participants. However, it's important to note that the clinical trial was originally posted on May 4th 2011 and updated as recently as October 25th of this year. Additionally, there are nearly 2000 other trials currently open for enrollment."

Answered by AI

Do we have any precedent for abiraterone acetate's efficacy when used in concert with prednisone?

"The 647th completed study of abiraterone acetate in combination with prednisone was at Hulston Cancer Center. Currently,378 trials are recruiting patients with a large concentration being in Huntsville, Alabama."

Answered by AI

What are the approved indications for abiraterone acetate in combination with prednisone?

"Abiraterone acetate in combination with prednisone can be used to ameliorate the symptoms of thyroiditis, ulcerative colitis, and malignant neoplasms."

Answered by AI

What is the FDA's current stance on abiraterone acetate in correlation to prednisone?

"We have rated the safety of abiraterone acetate in combination with prednisone as a 2. This is based on it being a phase 2 trial, where there is data supporting its safety, but none yet for efficacy."

Answered by AI

Are individuals aged 30 or more eligible for this research?

"This particular clinical trial is available to patients aged 18 to 99. There are 142 other trials for minors and 1682 studies for senior citizens."

Answered by AI

How many participants are allowed in this clinical trial?

"This particular clinical trial is not currently seeking participants. It was originally posted on May 4th, 2011 and last edited on October 25th, 2022. However, there are 1367 trials for prostate cancer and 378 trials involving abiraterone acetate that are actively enrolling patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

IMAAGEN: Impact of Abiraterone Acetate in Prostate-Specific Antigen

2011. "IMAAGEN: Impact of Abiraterone Acetate in Prostate-Specific Antigen". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01314118.

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