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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
Prior radical prostatectomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

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 below
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My prostate cancer was confirmed through a tissue examination.
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I have had surgery to remove my prostate.
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My prostate cancer has returned, and my PSA levels are rising quickly.
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I have had radiation before or am not suitable for it due to my health condition.
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My scans show no clear signs of cancer spread, except possibly small lymph nodes or unclear bone lesions.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I am 18 years old or older.
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I stopped taking any seizure-risk increasing meds 4 weeks before starting treatment.
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My recent lab tests show my organs are functioning well.
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My blood potassium level is at least 3.5 mmol/L.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 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
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 more

Awards & Highlights

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.

Trial 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
~1510
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
971 Previous Clinical Trials
6,383,080 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

Abiraterone Acetate (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03009981 — Phase 3
Prostate Cancer Research Study Groups: Arm A: Degarelix Monotherapy OR Leuprolide/Bicalutamide, Arm B: Degarelix/Apalutamide, Arm C: Degarelix/Apalutamide/Abiraterone/Prednisone
Prostate Cancer Clinical Trial 2023: Abiraterone Acetate Highlights & Side Effects. Trial Name: NCT03009981 — Phase 3
Abiraterone Acetate (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03009981 — Phase 3

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
Recent research and studies
~23 spots leftby Jul 2024