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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up starting after 12 weeks, at the beginning of week 4 of combination therapy with docetaxel, apalutamide, abiraterone acetate plus prednisone until psa progression or study completion (~36 months)
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ starting after 12 weeks, at the beginning of week 4 of combination therapy with docetaxel, apalutamide, abiraterone acetate plus prednisone until psa progression or study completion (~36 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~starting after 12 weeks, at the beginning of week 4 of combination therapy with docetaxel, apalutamide, abiraterone acetate plus prednisone until psa progression or study completion (~36 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with dose limiting toxicities (DLT)
Secondary outcome measures
Change in CellSearch circulating tumor cells (CTC) enumration
Change in PSA response
Change in the number of subjects with prostate-specific antigen (PSA) response
+2 moreTrial 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
1,059 Previous Clinical Trials
1,316,127 Total Patients Enrolled
49 Trials studying Prostate Cancer
34,611 Patients Enrolled for Prostate Cancer
Janssen Scientific Affairs, LLCIndustry Sponsor
159 Previous Clinical Trials
580,503 Total Patients Enrolled
11 Trials studying Prostate Cancer
1,343 Patients Enrolled for Prostate Cancer
Ana Molina, MDPrincipal InvestigatorWeill Medical College of Cornell University
1 Previous Clinical Trials
10 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have moderate to severe nerve damage.I have previously been treated with apalutamide.I have not used any experimental drugs or had any invasive devices implanted in the last 4 weeks.I've had chemotherapy for advanced prostate cancer but no chemo for other diseases in the last 3 years.I have not had prostate surgery or treatment in the last 30 days.I have received beta-emitting bone-seeking radioisotope treatment.I have had adrenal insufficiency or hyperaldosteronism.I am allergic to specific cancer medications or their ingredients.My prostate cancer was confirmed by a lab test.I will stop taking herbal and alternative supplements before starting treatment, but I can continue with my daily multi-vitamin, calcium, and Vitamin D.My testosterone levels are below 50 ng/dL, and I am on hormone therapy unless I've had an orchiectomy.My blood and organ functions are within normal ranges.I can swallow pills without needing to crush, dissolve, or chew them.I have a long-term liver condition.I have been on a stable dose of bisphosphonates or Denosumab for at least 4 weeks.I can take care of myself and am up and about more than half of the day.I received radiation for prostate cancer less than 4 weeks ago.My cancer has spread to my brain.I haven't taken azole medications like Fluconazole in the last 2 weeks.I stopped taking any seizure-risk increasing meds 4 weeks before starting the study drug.My prostate cancer is worsening, shown by tests like PSA levels or scans.I haven't taken strong CYP3A4 drugs in the last 2 weeks.I have active or symptomatic viral hepatitis.I am older than 18 years.
Research Study Groups:
This trial has the following groups:- Group 1: All patients
Awards:
This trial has 3 awards, including:- 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.
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.
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