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Hormone Therapy
Apalutamide + Abiraterone Acetate for Prostate Cancer
Phase 3
Waitlist Available
Led By Monica Bertagnolli, MD
Research Sponsored by Alliance Foundation Trials, LLC.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically confirmed prostate adenocarcinoma
Eastern Cooperative Oncology Group (ECOG) Performance Status grade 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 years
Awards & highlights
Study Summary
This trial is testing whether two different drugs can extend the time before cancer progresses in men with recurrent prostate cancer.
Who is the study for?
Men with high-risk, biochemically recurrent prostate cancer and a PSA doubling time of ≤9 months. They must have had prior surgery or radiation, no metastases on scans, an ECOG status of 0-1 (fully active to restricted in physically strenuous activity), and agree to contraception use. Exclusions include previous chemotherapy for prostate cancer (except as neoadjuvant/adjuvant therapy), recent use of certain medications, uncontrolled hypertension, severe liver impairment, and conditions predisposing to seizures.Check my eligibility
What is being tested?
This phase 3 trial is testing the effectiveness of three different treatment combinations: Apalutamide with LHRH Analogue; Abiraterone Acetate with Prednisone; or both combinations together in men whose prostate cancer has returned but without visible metastasis. Participants are randomly assigned to one of these three groups.See study design
What are the potential side effects?
Possible side effects include fatigue, hot flashes, joint pain from Apalutamide; hormonal changes from LHRH Analogues; increased blood pressure and mineral imbalances from Abiraterone Acetate; weight gain and mood swings from Prednisone. Each person's experience may vary.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My prostate cancer was confirmed through a tissue examination.
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I am fully active or can carry out light work.
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I have had surgery to remove my prostate.
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I am 18 years old or older.
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My prostate cancer has returned, and my PSA levels are doubling in 9 months or less.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
PSA progression-free survival in the intent-to-treat population
Secondary outcome measures
Metastasis-Free Survival
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Overall Survival
+9 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Arm C: Degarelix/Apalutamide/Abiraterone/PrednisoneExperimental Treatment4 Interventions
Patients will receive apalutamide and abiraterone acetate, in addition to either degarelix OR leuprolide. Patients on this arm will NOT take bicalutamide at any point in the treatment course.
Group II: Arm B: Degarelix/ApalutamideExperimental Treatment2 Interventions
Patients will receive apalutamide and either degarelix OR leuprolide. Patients on this arm will NOT take bicalutamide at any point in the treatment course.
Group III: Arm A: Degarelix Monotherapy OR Leuprolide/BicalutamideActive Control1 Intervention
Patients will receive degarelix OR leuprolide with bicalutamide.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Apalutamide
2015
Completed Phase 2
~3310
Abiraterone Acetate
2015
Completed Phase 4
~1880
Prednisone
2014
Completed Phase 4
~2370
Find a Location
Who is running the clinical trial?
Alliance Foundation Trials, LLC.Lead Sponsor
23 Previous Clinical Trials
24,528 Total Patients Enrolled
2 Trials studying Prostate Cancer
11,446 Patients Enrolled for Prostate Cancer
Janssen Research & Development, LLCIndustry Sponsor
975 Previous Clinical Trials
6,383,804 Total Patients Enrolled
7 Trials studying Prostate Cancer
1,674 Patients Enrolled for Prostate Cancer
Monica Bertagnolli, MDPrincipal InvestigatorAlliance Foundation Trials, LLC.
11 Previous Clinical Trials
8,328 Total Patients Enrolled
1 Trials studying Prostate Cancer
132 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or can carry out light work.I haven't taken 5-alpha reductase inhibitors in the last 42 days.My blood tests show normal liver, kidney, and blood health.My scans show no clear signs of cancer spread, except for small lymph nodes or unclear bone lesions.My prostate cancer was confirmed through a tissue examination.I have a stomach or intestine condition that affects how I absorb medicine or swallow pills.I have had chemotherapy for prostate cancer only as part of initial treatment.I've had hormone therapy for prostate cancer but stopped it more than 9 months ago.I have been treated with specific prostate cancer medications before.I have had both testicles surgically removed.I stopped taking any seizure-risk increasing meds 4 weeks before starting treatment.My liver is not working well (Child-Pugh B or C).I haven't taken any prohibited medications in the last 7 days.I take more than 5 mg of prednisone or its equivalent daily for a chronic condition.I have had surgery to remove my prostate.My high blood pressure is not under control.I am 18 years old or older.I have had radiation before or am not suitable for it due to my health condition.My prostate cancer has returned, and my PSA levels are doubling in 9 months or less.I have a condition or history that increases my risk of seizures.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A: Degarelix Monotherapy OR Leuprolide/Bicalutamide
- Group 2: Arm B: Degarelix/Apalutamide
- Group 3: Arm C: Degarelix/Apalutamide/Abiraterone/Prednisone
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Are there any historical data points we can review for Apalutamide?
"The first study involving apalutamide was completed at Centre de Recherche Clinique du CHUS in the year 2000. As of now, 899 trials have been completed with apalutamide. Additionally, there are currently482 live trials being conducted; a majority of these taking place in South Weymouth, Massachusetts."
Answered by AI
Could you tell me how many research hospitals are running this study?
"Patients are currently being accepted at the Dana Farber Cancer Institute, VA Western New york, and University of Chicago Comprehensive Cancer Center. Additionally, there are 57 other sites where this trial is running."
Answered by AI
For what purpose is Apalutamide most often prescribed?
"Apalutamide is most frequently used to manage non-metastatic prostate cancer. Other possible indications for apalutamide use include ulcerative colitis, varicella-zoster virus acute retinal necrosis, and brain cancer."
Answered by AI
Is this a new development in the medical field?
"As of now, there are 482 ongoing studies for Apalutamide in 69 different countries and 2305 cities. The first trial started in 2000 and was sponsored by AstraZeneca. That particular study, which completed its Phase 3 drug approval stage, had 600 participants. 899 trials have been completed in the 20 years since the Apalutamide's initial study."
Answered by AI
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