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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

Must not have

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 active hepatitis or chronic liver disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up maximum up to month 30.5

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has spread or gotten worse according to specific criteria.

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I have active hepatitis or chronic liver disease.

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I have a serious heart condition.

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I have been treated for prostate cancer with drugs that affect hormone production.

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I am currently on antiandrogen therapy.

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I do not have any infections or conditions that prevent me from taking prednisone.

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My diabetes is not well-managed.

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I have taken aminoglutethimide before.

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My high blood pressure is not under control.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 15Eligibility criteria met