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Hormone Therapy

Apalutamide + Abiraterone + Prednisone for Prostate Cancer

Q: What medical issues is Treatment (abiraterone acetate, apalutamide, prednisone) commonly prescribed to address?

<p><a href="https://www.withpower.com/clinical-trials/abiraterone-acetate">Abiraterone acetate</a>, apalutamide and prednisone are commonly administered to treat scalp structure. Additionally, the same trio of medications is effective at managing thyroiditis, non-<a href="https://www.withpower.com/clinical-trials/metastatic-prostate-cancer">metastatic prostate cancer</a>, and <a href="https://www.withpower.com/clinical-trials/ulcerative-colitis">ulcerative colitis</a>.</p>

Phase 2

Waitlist Available

Led By Bagi Jana, MD

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

Presence of metastatic disease that can be biopsied by any methodology applicable

Ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analogue or orchiectomy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 28 months

Awards & highlights

Study Summary

This trial studies how well 2 drugs plus steroids work to treat prostate cancer that has spread to other parts of the body. They may stop cancer growth by blocking enzymes needed for cell growth.

Who is the study for?

Men with metastatic castration resistant prostate cancer, who have low testosterone levels and progressive disease despite ongoing hormone therapy. They must be able to give consent, swallow pills, and agree to use two forms of birth control if sexually active with a woman of childbearing potential. Excluded are those with severe health issues like uncontrolled hypertension or heart problems, recent major surgery, brain metastases, certain blood disorders or allergies to study drugs.Check my eligibility

What is being tested?

The trial is testing the effectiveness of combining apalutamide and abiraterone acetate—drugs that block tumor growth enzymes—with prednisone which suppresses the immune system and may improve bone marrow function in treating metastatic prostate cancer that resists castration treatment.See study design

What are the potential side effects?

Potential side effects include fatigue, digestive issues such as nausea or diarrhea, liver problems indicated by changes in blood tests results for liver function; skin rash; joint pain; high blood pressure; fluid retention leading to swelling in legs or feet; hot flushes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer has spread and can be biopsied.

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I am currently on hormone therapy for cancer or have had an orchiectomy.

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I have had at most two chemotherapy treatments for my metastatic prostate cancer.

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I am fully active or can carry out light work.

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My cancer has worsened, shown by rising PSA levels or growth in bones or soft tissues.

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My prostate cancer is confirmed and does not have neuroendocrine or small cell features.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 28 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 28 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 28 months for reporting.

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

Androgen expression signaling

Composite progression free survival (PFSc)

Incidence of adverse events

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (abiraterone acetate, apalutamide, prednisone)Experimental Treatment3 Interventions

Participants receive abiraterone acetate PO once daily QD, apalutamide PO QD, and prednisone PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Prednisone

2014

Completed Phase 4

~2370

Abiraterone Acetate

2015

Completed Phase 4

~1880

Apalutamide

2015

Completed Phase 2

~3310

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,933,660 Total Patients Enrolled

561 Trials studying Prostate Cancer

507,173 Patients Enrolled for Prostate Cancer

M.D. Anderson Cancer CenterLead Sponsor

2,967 Previous Clinical Trials

1,804,795 Total Patients Enrolled

96 Trials studying Prostate Cancer

29,740 Patients Enrolled for Prostate Cancer

Bagi Jana, MDPrincipal InvestigatorM.D. Anderson Cancer Center

Frequently Asked Questions

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

What medical issues is Treatment (abiraterone acetate, apalutamide, prednisone) commonly prescribed to address?

"Abiraterone acetate, apalutamide and prednisone are commonly administered to treat scalp structure. Additionally, the same trio of medications is effective at managing thyroiditis, non-metastatic prostate cancer, and ulcerative colitis."

Answered by AI

How many participants are contributing to this clinical trial?

"This study is no longer recruiting participants. Initially posted on 6th March 2018 and last updated on 10th August 2023, it has ceased accepting new patients. However, there are 1247 trials actively searching for people with prostate cancer and 399 clinical studies investigating the effects of abiraterone acetate, apalutamide or prednisone currently recruiting volunteers."

Answered by AI

Has the FDA cleared abiraterone acetate, apalutamide and prednisone for therapeutic use?

"This treatment has been evaluated for safety in a Phase 2 trial, so we have assigned it an intermediate score of two. Although there is evidence that this intervention does not pose any major risks to patients, there are no long-term data attesting to its efficacy."

Answered by AI

Are applications currently being considered for this experiment?

"At the present time, this study is not recruiting. Initially posted on March 6th 2018 and last updated August 10th 2023, it no longer seeks participants. Nevertheless, 1247 trials for prostate cancer are still enrolling patients along with 399 that primarily involve using abiraterone acetate , apalutamide or prednisone as a treatment option."

Answered by AI

What evidence has been amassed in regards to abiraterone acetate, apalutamide and prednisone?

"Presently, 399 clinical trials are underway to investigate the effects of Treatment (abiraterone acetate, apalutamide, prednisone). Of these active studies, 119 have reached Phase 3. Although most of these research initiatives take place in Duarte California, there are 19362 sites across the globe running experiments on this treatment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Apalutamide, Abiraterone Acetate, and Prednisone in Treating Participants With Metastatic Castration Resistant Prostate Cancer

2018. "Apalutamide, Abiraterone Acetate, and Prednisone in Treating Participants With Metastatic Castration Resistant Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03360721.

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