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Hormone Therapy

Abiraterone + Antiandrogen +/- Chemotherapy for Advanced Prostate Cancer

Colorado Springs, CO

Phase 2

Waitlist Available

Led By Christos Kyriakopoulos

Research Sponsored by ECOG-ACRIN Cancer Research Group

Eligibility Criteria Checklist

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

Must have

Histologically confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate)

Metastatic disease as evidenced by the presence of soft tissue and/or bone metastases on imaging studies

Must not have

Medical condition for which prednisone is contraindicated

Recent myocardial infarction or arterial thrombotic event

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing abiraterone acetate and antiandrogen therapy, with or without cabazitaxel and prednisone, to see how well it works in treating patients with castration-resistant prostate cancer that has spread to other parts of the body and has been previously treated with docetaxel.

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Who is the study for?

Men with metastatic, castration-resistant prostate cancer previously treated with docetaxel can join. They must have low testosterone levels, adequate organ function, and no active infections or recent heart issues. Participants need to be on standard hormone therapy and not taking other investigational drugs. Men who've had certain treatments like radium-223 are allowed.Check my eligibility

What is being tested?

The trial is testing if adding cabazitaxel and prednisone to abiraterone acetate and antiandrogen therapy improves outcomes in patients whose prostate cancer has spread despite treatment. It's a randomized study comparing the effectiveness of these combinations after previous chemotherapy.See study design

What are the potential side effects?

Possible side effects include reactions related to hormone therapy such as fatigue, hot flashes, decreased libido; chemotherapy-related issues like hair loss, nausea; prednisone may cause weight gain or mood changes; all medications could potentially lead to allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with prostate cancer.

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My cancer has spread to my bones or soft tissues, as shown by scans.

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I can swallow pills without any difficulty.

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I am currently on standard hormone therapy for my cancer.

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I have undergone at least 3 cycles of docetaxel for my prostate cancer.

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I am a sexually active male and will use double barrier contraception or abstain.

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My testosterone levels are below 50 ng/dL.

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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 have had surgery or radiation for brain cancer spread.

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My cancer has worsened despite hormone therapy.

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Exclusion Criteria

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

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Prednisone is not safe for me due to my medical condition.

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I have not had a recent heart attack or blood clot in an artery.

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I have received chemotherapy or therapy targeting the androgen receptor for prostate cancer.

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My prostate cancer is not the common type but a rare form.

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I have a history of adrenal insufficiency or low aldosterone levels.

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I have a history of cancer.

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I experience significant numbness or pain in my hands or feet.

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I am not currently on any experimental drugs or other cancer treatments.

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I do not have uncontrolled chest pain or severe heart rhythm problems.

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I am currently being treated for an infection with antibiotics.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Progression free survival (PFS)

Secondary study objectives

Incidence of adverse events assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

Maximum decline in PSA while on treatment

Overall survival (OS)

+3 more

Other study objectives

Change in AR-V7 status in circulating tumor cells

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm A (abiraterone acetate, prednisone, cabazitaxel)Experimental Treatment7 Interventions

Patients receive abiraterone acetate PO QD on days 1-21, prednisone PO BID on days 1-21. Courses of abiraterone acetate and prednisone repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients receive cabazitaxel IV over 1 hour on day 1, and treatment with cabazitaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive standard of care antiandrogen therapy with either LHRH agonist or antagonist, or surgical castration with bilateral orchiectomy.

Group II: Arm B (abiraterone acetate, prednisone)Active Control6 Interventions

Patients receive abiraterone acetate and prednisone as in Arm A. Patients also receive standard of care antiandrogen therapy with either LHRH agonist or antagonist, or surgical castration with bilateral orchiectomy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cabazitaxel

2014

Completed Phase 3

~1290

Prednisone

2014

Completed Phase 4

~2500