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Hormone Therapy
Abiraterone + Antiandrogen +/- Chemotherapy for Advanced Prostate Cancer
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
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.
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 belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression free survival (PFS)
Secondary outcome measures
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 moreOther outcome measures
Change in AR-V7 status in circulating tumor cells
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
Abiraterone Acetate
2015
Completed Phase 4
~1880
Antiandrogen Therapy
2015
Completed Phase 1
~10
Cabazitaxel
2014
Completed Phase 3
~1290
Orchiectomy
2010
Completed Phase 4
~50
Prednisone
2014
Completed Phase 4
~2370
Find a Location
Who is running the clinical trial?
ECOG-ACRIN Cancer Research GroupLead Sponsor
116 Previous Clinical Trials
176,699 Total Patients Enrolled
5 Trials studying Prostate Cancer
1,922 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,959,178 Total Patients Enrolled
566 Trials studying Prostate Cancer
529,005 Patients Enrolled for Prostate Cancer
Christos KyriakopoulosPrincipal InvestigatorECOG-ACRIN Cancer Research Group
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I may have been treated with a specific hormone therapy before.I have stopped any antiandrogen treatment for at least 4-6 weeks and my PSA levels have increased since then.I am on standard hormone therapy for my cancer.I have received chemotherapy or therapy targeting the androgen receptor for prostate cancer.My prostate cancer is not the common type but a rare form.I have a history of adrenal insufficiency or low aldosterone levels.I have a history of cancer.I experience significant numbness or pain in my hands or feet.I have been diagnosed with prostate cancer.My cancer has spread to my bones or soft tissues, as shown by scans.I can swallow pills without any difficulty.I am currently on standard hormone therapy for my cancer.I have undergone at least 3 cycles of docetaxel for my prostate cancer.I am a sexually active male and will use double barrier contraception or abstain.Prednisone is not safe for me due to my medical condition.I have not had a recent heart attack or blood clot in an artery.I have not had external beam radiation therapy in the last 4 weeks.My testosterone levels are below 50 ng/dL.I am not currently on any experimental drugs or other cancer treatments.I do not have uncontrolled chest pain or severe heart rhythm problems.I can take care of myself and am up and about more than half of my waking hours.I am currently being treated for an infection with antibiotics.I have had surgery or radiation for brain cancer spread.My cancer has worsened despite hormone therapy.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B (abiraterone acetate, prednisone)
- Group 2: Arm A (abiraterone acetate, prednisone, cabazitaxel)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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