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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study 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.
Select...
I have undergone at least 3 cycles of docetaxel for my prostate cancer.
Select...
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.
Select...
My cancer has worsened despite hormone therapy.
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
13,654 Previous Clinical Trials
40,932,930 Total Patients Enrolled
561 Trials studying Prostate Cancer
507,173 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is participation in this research endeavor available for patients at this time?
"As per clinicaltrials.gov, this clinical trial continues to seek participants for enrollment. The study was initially publicized on February 8th 2018 and has experienced alterations as recently December 29th 2021."
Answered by AI
Are there any existing studies on the efficacy of Antiandrogen Therapy?
"Antiandrogen Therapy was initially explored in 2001 at Providence Cancer Center. Subsequently, 1515 clinical trials were successfully finished and there are currently 445 active studies with a significant number of them located in Saint Paul, Missouri."
Answered by AI
What implications does Antiandrogen Therapy pose for its recipients?
"With Phase 2 clinical trial data only confirming its safety, Antiandrogen Therapy received a score of 2."
Answered by AI
What is the upper limit for enrollment in this clinical trial?
"Affirmative, according to clinicaltrials.gov this trial is still recruiting participants. It was initially posted on February 8th 2018 and it has been updated as recently as December 29th 2021. A total of 210 individuals are required across 100 sites."
Answered by AI
What therapeutic indications is Antiandrogen Therapy typically employed for?
"Antiandrogen Therapy has been proven to help alleviate the symptoms associated with scalp structure, thyroiditis, and ulcerative colitis."
Answered by AI
How many sites have been designated to carry out this clinical trial?
"At present, this study is running at a hundred clinics around the nation. Examples of cities with recruitment centres include Saint Paul, Kansas City and Las Vegas - among many others. To minimise travel commitments for potential participants, we recommend selecting the closest site to your location."
Answered by AI
Who else is applying?
What state do they live in?
Georgia
Nevada
What site did they apply to?
CTCA at Southeastern Regional Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
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