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Androgen Receptor Inhibitor

Combination Therapy for Prostate Cancer

Phase 2
Waitlist Available
Led By Ana Aparicio
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
New or increasing non-bone disease (Response Evaluation Criteria in Solid Tumors [RECIST] 1.1)
Surgically or ongoing medically castrated, with baseline testosterone levels of =< 50 ng/dL (=< 2.0 nM)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights

Study Summary

This trial is testing abiraterone acetate, prednisone, and apalutamide with or without ipilimumab or cabazitaxel and carboplatin to treat patients with castration-resistant prostate cancer.

Who is the study for?
Men with advanced prostate cancer that is resistant to castration and has spread, who can provide consent, have adequate organ function (blood counts, liver enzymes), and are not on certain medications. They must have a low testosterone level due to surgery or ongoing treatment, be able to swallow pills, agree to use contraception if necessary, and allow tissue collection for studies.Check my eligibility
What is being tested?
The trial tests how well abiraterone acetate, prednisone, and apalutamide work together compared with the addition of ipilimumab or cabazitaxel plus carboplatin. It aims to see which combination is more effective in stopping tumor growth by reducing androgens or killing tumor cells directly.See study design
What are the potential side effects?
Possible side effects include immune system reactions from monoclonal antibodies like ipilimumab; chemotherapy-related issues such as nausea; fatigue; blood cell count changes from drugs like cabazitaxel and carboplatin; hormonal changes due to abiraterone acetate and apalutamide.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer outside of bones is growing or new.
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I am undergoing treatment to lower my testosterone levels below 50 ng/dL.
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I can take care of myself but might not be able to do heavy physical work.
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My hemoglobin level is at least 7.5 g/dL without transfusions or growth factors in the last 3 months.
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My platelet count is at least 100,000 without transfusions in the last 3 months.
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I stopped taking any medication that could increase my risk of seizures 4 weeks ago.
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My kidneys are functioning well enough (creatinine clearance >= 40 mL/min).
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I agree to use two forms of birth control and not donate sperm until 3 months after my last treatment dose.
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My liver enzymes are within the required range for my condition.
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My prostate cancer was confirmed by a lab test.
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My bone scan shows 2 or more new lesions due to prostate cancer.
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I can swallow pills without any difficulty.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Allocation serum marker decline
Androgen receptor (AR) response marker signature
Incidence of adverse events as measured by the method of Thall et al
+1 more
Secondary outcome measures
Time to treatment failure (TTF)

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Arm 2B (abiraterone acetate, prednisone, ARN-509, ipilimumab)Experimental Treatment5 Interventions
Patients receive abiraterone acetate PO daily, prednisone PO BID, and apalutamide PO daily. Patients also receive ipilimumab IV over 90 minutes on day 1 of courses 4-7. Courses repeat every 3 weeks in the absence of disease progression or unexpected toxicity.
Group II: Arm 2A (abiraterone acetate, prednisone, apalutamide)Experimental Treatment4 Interventions
Patients receive abiraterone acetate PO daily, prednisone PO BID, and apalutamide PO daily in the absence of disease progression or unexpected toxicity.
Group III: Arm 3(abiraterone, prednisone, ARN509,cabazitaxel,carboplatin)Active Control6 Interventions
Patients receive abiraterone acetate PO daily, prednisone PO BID, and apalutamide PO daily. Patients also receive cabazitaxel IV over 60 minutes and carboplatin IV, over 60 minutes on day 1 of courses 4-13. Courses repeat every 3 weeks in the absence of disease progression or unexpected toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abiraterone Acetate
2015
Completed Phase 4
~1880
Apalutamide
2015
Completed Phase 2
~1510
Prednisone
2014
Completed Phase 4
~2370
Ipilimumab
2014
Completed Phase 3
~2640

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,253 Total Patients Enrolled
96 Trials studying Prostate Cancer
29,740 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,450 Total Patients Enrolled
560 Trials studying Prostate Cancer
507,154 Patients Enrolled for Prostate Cancer
Ana AparicioPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
225 Total Patients Enrolled

Media Library

Abiraterone Acetate (Androgen Receptor Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02703623 — Phase 2
Prostate Cancer Research Study Groups: Arm 3(abiraterone, prednisone, ARN509,cabazitaxel,carboplatin), Arm 2A (abiraterone acetate, prednisone, apalutamide), Arm 2B (abiraterone acetate, prednisone, ARN-509, ipilimumab)
Prostate Cancer Clinical Trial 2023: Abiraterone Acetate Highlights & Side Effects. Trial Name: NCT02703623 — Phase 2
Abiraterone Acetate (Androgen Receptor Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02703623 — Phase 2

Frequently Asked Questions

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

For which illnesses is Abiraterone Acetate typically prescribed?

"Abiraterone acetate is frequently used as a first-line therapy, and has also been demonstrated to be therapeutic for ophthalmia, sympathetic neuralgia, scalp structure irregularities, and advanced testicular cancer."

Answered by AI

What hazards are associated with Abiraterone Acetate consumption?

"An overall assessment of abiraterone acetate's safety yielded a rating of 2. This is due to the fact that, since it has only reached Phase 2 clinical trials, there are no studies as yet providing evidence for its efficacy; however, some data does exist suggesting its safety."

Answered by AI

How many individuals are partaking in this experiment?

"Unfortunately, this medical trial is not presently recruiting. First posted on May 18th 2016 and last updated on February 11th 2022, the study has since concluded its recruitment process. However, there are 3,650 studies searching for participants with carcinoma and 1,455 trials actively administering Abiraterone acetate to patients."

Answered by AI

Is there still an opportunity to become involved with this research endeavor?

"As seen on clinicaltrials.gov the recruitment process for this medical trial has officially ended, with its initial post date being May 18th 2016 and its last update occurring February 11th 2022. Nevertheless, there are a multitude of other studies that require participants at present - 5105 to be exact."

Answered by AI

What prior research has been conducted regarding the application of Abiraterone Acetate?

"Currently, there are 1455 active research studies into Abiraterone acetate, with 383 of them in Phase 3. Majority of these clinical investigations take place in Shanghai; however, this compound is getting tested on 83312 different sites worldwide."

Answered by AI
~25 spots leftby May 2025