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Antiandrogen

Combination Therapy for Prostate Cancer

Phase 1
Waitlist Available
Led By Ana Molina, MD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically or cytologically confirmed adenocarcinoma of prostate
Serum testosterone < 50 ng/dL. Subjects must continue primary androgen deprivation with an LHRH/GnRH analogue (agonist/antagonist) if they have not undergone orchiectomy
Must not have
Current evidence of uncontrolled hypertension, gastrointestinal disorder affecting absorption, active infection (e.g., human immunodeficiency virus [HIV] or viral hepatitis) or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated, chronic medical condition requiring a higher dose of corticosteroid than 10 mg prednisone/prednisolone once daily, any condition that in the opinion of the investigator would preclude participation in this study, patients with baseline severe hepatic impairment (Child Pugh Class C), severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to treatment start or New York Heart Association (NYHA) Class II to IV heart disease, seizure or known condition that may pre-dispose to seizure, having partners of childbearing potential and not willing to use a method of birth control deemed acceptable by the principle investigator and chairperson during the study and for 1 week after last study drug administration
Pre-existing neuropathy ≥Grade 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up collected at baseline, 12 weeks and at end of study, an average of 100 months
Awards & highlights
All Individual Drugs Already Approved
Approved for 30 Other Conditions
No Placebo-Only Group

Summary

This trial will enroll patients with metastatic mCRPC who have not been previously treated with abiraterone or docetaxel.

Who is the study for?
Men over 18 with advanced prostate cancer that's resistant to hormone therapy can join. They need a certain level of health, like normal organ/marrow function and controlled blood pressure. They must not have had recent heart issues, seizures, or certain treatments like chemotherapy for prostate cancer within the last 3 years.
What is being tested?
This trial tests Apalutamide combined with Abiraterone Acetate, Docetaxel, and Prednisone in men with metastatic castration-resistant prostate cancer (mCRPC). It aims to find the safest dose for Apalutamide when used with these other drugs.
What are the potential side effects?
Possible side effects include fatigue, digestive problems like nausea and diarrhea, allergic reactions to medication components, increased risk of infections due to steroid use (Prednisone), liver function changes, and potential impact on blood cell counts.

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 by a lab test.
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My testosterone levels are below 50 ng/dL, and I am on hormone therapy unless I've had an orchiectomy.
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My blood and organ functions are within normal ranges.
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I can swallow pills without needing to crush, dissolve, or chew them.
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I can take care of myself and am up and about more than half of the day.
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My prostate cancer is worsening, shown by tests like PSA levels or scans.
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I am older than 18 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have moderate to severe nerve damage.
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I have not used any experimental drugs or had any invasive devices implanted in the last 4 weeks.
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I have received beta-emitting bone-seeking radioisotope treatment.
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I have had adrenal insufficiency or hyperaldosteronism.
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I am allergic to specific cancer medications or their ingredients.
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I have a long-term liver condition.
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My cancer has spread to my brain.
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I haven't taken azole medications like Fluconazole in the last 2 weeks.
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I haven't taken strong CYP3A4 drugs in the last 2 weeks.
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I have active or symptomatic viral hepatitis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~collected at baseline, 12 weeks and at end of study, an average of 100 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and collected at baseline, 12 weeks and at end of study, an average of 100 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants with dose limiting toxicities (DLT)
Secondary study objectives
Change in CellSearch circulating tumor cells (CTC) enumration
Change in PSA response
Change in the time to PSA progression
+1 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 30 Other Conditions
This treatment demonstrated efficacy for 30 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: All patientsExperimental Treatment4 Interventions
Apalutamide, 120 mg (cohort 1), 240 mg (cohort 2), 180 mg (cohort 3) Abiraterone Acetate 1000mg Prednisone 10mg Docetaxel 75 mg/m2
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abiraterone
FDA approved
Docetaxel
FDA approved
Apalutamide
FDA approved
Prednisone
FDA approved

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,085 Previous Clinical Trials
1,147,306 Total Patients Enrolled
49 Trials studying Prostate Cancer
34,597 Patients Enrolled for Prostate Cancer
Janssen Scientific Affairs, LLCIndustry Sponsor
164 Previous Clinical Trials
579,957 Total Patients Enrolled
11 Trials studying Prostate Cancer
957 Patients Enrolled for Prostate Cancer
Ana Molina, MDPrincipal InvestigatorWeill Medical College of Cornell University
1 Previous Clinical Trials
10 Total Patients Enrolled

Media Library

Abiraterone acetate (Antiandrogen) Clinical Trial Eligibility Overview. Trial Name: NCT02913196 — Phase 1
Prostate Cancer Research Study Groups: All patients
Prostate Cancer Clinical Trial 2023: Abiraterone acetate Highlights & Side Effects. Trial Name: NCT02913196 — Phase 1
Abiraterone acetate (Antiandrogen) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02913196 — Phase 1
~2 spots leftby Nov 2025
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