Phase I Trial of Apalutamide Plus Abiraterone Acetate, Docetaxel, and Prednisone in Patients With mCRPC

Completed · Phase 1

Conditions studied: Prostate Cancer Metastatic

In brief

This is a multi-center, Phase I study of apalutamide in combination with abiraterone acetate, docetaxel and prednisone in patients with metastatic mastrate resistant prostate cancer (mCRPC). This study is designed to determine the dose that apalutamide can be administered safely in combination with abiraterone acetate, docetaxel and prednisone.

Key facts

Study ID

NCT02913196

Run by

Weill Medical College of Cornell University

People needed

16

Starts

2016-12-30

Expected to finish

2025-10-15

Last updated by the study team

2026-04-20

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed adenocarcinoma of prostate
• Documented progressive metastatic CRPC based on at least one of the following criteria:
• PSA progression according to Prostate Cancer Working Group 3 (PCWG3) criteria
• Objective radiographic progression in soft tissue, according to modified Response Evaluation Criteria In Solid Tumors (RECIST) or bone scans
• ECOG performance status of 0-2
• Have serum testosterone < 50 ng/dL. Subjects must continue primary androgen deprivation with an LHRH/GnRH analogue (agonist/antagonist) if they have not undergone orchiectomy
• Age >18 years
• Patients must have normal organ and marrow function as defined below:
• Absolute neutrophil count >1,500/cells/mm3
• Hemoglobin ≥ 9 g/dL
• Platelet count >100,000 x 109/microliter
• Serum creatinine <1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 60 mL/min/1.73 m2 by Cockcroft-Gault
• Serum albumin ≥3.2 g/dL
• Serum potassium ≥3.5 mmol/L
• Patients must be able to take oral medication without crushing, dissolving or chewing tablets
• Ability to understand and the willingness to sign a written informed consent document
• Medications known to lower the seizure threshold (see list under prohibited medications) must be discontinued or substituted at least 4 weeks prior to study drug initiation
• Patients on stable dose of bisphosphonates or RANK-L inhibitor, Denosumab, which have been started no less than 4 weeks prior to treatment start, may continue on this medication

You may not qualify if…

• Liver Function
• If total bilirubin is >1.5 x ULN (NOTE: in subjects with Gilbert's syndrome, if total bilirubin is >1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is within normal range, subject may be eligible) or
• Alanine (ALT) or aspartate (AST) aminotransferase >1.5xULN (or >5xULN for subject with liver metastasis) concomitant with alkaline phosphatase >2.5xULN (or >5xULN for subjects with bone or liver metastases) or
• Alanine (ALT or aspartate (AST) aminotransferase >2.5xULN (or >5xULN for subjects with liver metastasis
• Use of investigational drugs (including vaccines) or implantation of invasive medical device ≤4 weeks or <5 half-lives of Cycle 1, Day 1 or current enrollment in investigational drug or device study
• Prior exposure to apalutamide. Prior exposure to abiraterone acetate and/or other CYP17 inhibitors, enzalutamide is allowed (but not preferred) only during the dose escalation period
• Prior chemotherapy for advanced prostate cancer. Prior chemotherapy for any other disease within 3 years
• Prior systemic beta-emitting bone-seeking radioisotopes (i.e. strontium-90)
• Pre-existing neuropathy ≥Grade 2
• Systemic azole treatment (e.g. Fluconazole, itracanozole) ≤2 weeks of Cycle 1 Day 1
• Use of potent inducers or inhibitors of CYP3A4 activity ≤2 weeks prior to Day 1 Cycle 1
• History of adrenal insufficiency or hyperaldosteronism
• Active or symptomatic viral hepatitis
• Chronic liver disease
• Brain metastases or leptomeningeal disease
• Known allergies, hypersensitivity or intolerance to abiraterone acetate, apalutamide, docetaxel, dexamethasone, prednisone, or their excipients
• Use of herbal, alternative and food supplements (i.e. PC-Spes, Saw Palmetto, St John Wort, etc) must be discontinued before treatment start. Daily Multi-vitamin, calcium and Vitamin D is allowed
• Surgery or local prostatic intervention within 30 days of first dose. [Note: Any clinically relevant sequelae from surgery must have resolved prior to Day 1 Cycle 1]
• Radiation therapy for treatment of prostate cancer ≤4 weeks of Day 1 Cycle 1
• Current evidence of any of the following:
• Uncontrolled hypertension (defined as blood pressure of >150 mmHg systolic and/or >100 mmHg diastolic on medication)
• 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
• Any 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

Where it is running

• GU Research Network/Urology Cancer Center — Omaha, Nebraska, United States
• Weill Cornell Medical College — New York, New York, United States

Full record on ClinicalTrials.gov

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