Abiraterone Acetate, Prednisone, and Apalutamide in Treating Patients With Hormone-Naive Metastatic Prostate Cancer

NCT03821792 | Active Not Recruiting Phase 2 FDA Drug

• 2 other identifiers: 2018-0533NCI-2018-03599
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies how well abiraterone acetate, prednisone, and apalutamide work in treating patients with hormone-naive prostate cancer that has spread to other places in the body. Androgen can cause the growth of prostate cancer cells. Antihormone therapy, such as abiraterone acetate and apalutamide may lessen the amount of androgen made by the body.

Conditions

Metastatic Prostate Carcinoma; Prostate Adenocarcinoma; Prostate Carcinoma Metastatic in the Bone; Stage IV Prostate Cancer AJCC v8; Stage IVA Prostate Cancer AJCC v8; Stage IVB Prostate Cancer AJCC v8

Outcome Measures

Primary Outcomes (1)

• Time on treatment

  Calculated as the time from start of protocol treatment

  Up to 6 months

Secondary Outcomes (5)

• Progression free survival (PFS)

  Time from starting treatment until progression, assessed up to 6 months

• Incidence of adverse events

  Up to 6 months

• Efficacy assessed

  Up to 6 months

• Expression of candidate markers

  Up to 6 months

• Overall survival

  up to 6 months

Study Arms (1)

Treatment (abiraterone acetate, prednisone, apalutamide)

EXPERIMENTAL

Patient receive abiraterone acetate PO daily, prednisone PO BID, and apalutamide PO daily. Cycles repeat every 28 days for 1 year in the absence of disease progression or unacceptable toxicity.

Drug: Abiraterone Acetate; Drug: Apalutamide; Drug: Prednisone

Interventions

Abiraterone Acetate DRUG

Given PO

Also known as: CB7630, Yonsa, Zytiga

Treatment (abiraterone acetate, prednisone, apalutamide)

Apalutamide DRUG

Given PO

Also known as: ARN 509, ARN-509, ARN509, Erleada, JNJ 56021927, JNJ-56021927

Treatment (abiraterone acetate, prednisone, apalutamide)

Prednisone DRUG

Given PO

Also known as: .delta.1-Cortisone, 1, 2-Dehydrocortisone, Adasone, Cortancyl, Dacortin, DeCortin, Decortisyl, Decorton, Delta 1-Cortisone, Delta-Dome, Deltacortene, Deltacortisone, Deltadehydrocortisone, Deltasone, Deltison, Deltra, Econosone, Lisacort, Meprosona-F, Metacortandracin, Meticorten, Ofisolona, Orasone, Panafcort, Panasol-S, Paracort, Perrigo Prednisone, PRED, Predicor, Predicorten, Prednicen-M, Prednicort, Prednidib, Prednilonga, Predniment, Prednisone Intensol, Prednisonum, Prednitone, Promifen, Rayos, Servisone, SK-Prednisone

Treatment (abiraterone acetate, prednisone, apalutamide)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed adenocarcinoma of the prostate
• At least 2 of the 3 following high-risk prognostic factors:
• Gleason score of \>= 8
• Presence of 3 or more lesions on bone scan
• Presence of measurable visceral (excluding lymph node disease) metastasis on computed tomography (CT) or magnetic resonance imaging (MRI) (Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1)
• Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2
• Hemoglobin \>= 9.0 g/dL independent of transfusion and/or growth factors within 3 months prior to enrollment
• Platelet count \>= 100,000/uL independent of transfusion and/or growth factors within 3 months prior to enrollment
• Serum albumin \>= 3.0 g/dL
• Medications known to lower the seizure threshold must be discontinued or substituted at least 4 weeks prior to study entry
• Absolute neutrophil count (ANC) \>= 1,500/mm\^3
• Calculated creatinine clearance (Cockcroft-Gault equation) \>= 45 mL/min
• Serum potassium \>= 3.5 mEg/L
• Serum magnesium \>= 1.6 mg/dL
• Serum bilirubin \< 1.5 x institutional upper limit of normal (IULN) (except for patients with known Gilbert's disease if total bilirubin is \> 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is =\< 1.5 x ULN, subject may be eligible)

You may not qualify if:

• Small cell prostate cancer
• Treatment within 28 days of cycle 1 day 1: Any prior pharmacotherapy, radiation therapy, or surgery for metastatic prostate cancer. The following exceptions are permitted:
• Up to 3 months of antiandrogen therapy (ADT) with LHRH agonists or antagonists or orchiectomy with or without concurrent anti-androgens prior to cycle 1 day 1. Anti-androgens (flutamide, bicalutamide or nilutamide) for subjects receiving an LHRH agonist must be discontinued within 2 weeks of cycle 1 day 1, or subjects may have one course of palliative radiation or surgical therapy to treat symptoms resulting from metastatic disease (e.g., impending cord compression or obstructive symptoms) if it was administered at least 28 days prior to cycle 1 day 1. All adverse events associated with these procedures must be resolved at least to grade 1 by cycle 1 day 1, or
• Any chronic medical condition requiring a higher dose of corticosteroid than 10 mg prednisone/prednisolone daily. Use of inhaled, intranasal, intra-articular and topical steroids are acceptable, as is a short course (i.e. =\< 1 day) of corticosteroids to prevent a reaction to the intravenous (IV) contrast used for CT scans
• Active infection (requiring oral or IV antibiotics or antiviral therapy) or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated. Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
• A malignancy (other than the one treated in this study) which required radiotherapy or systemic treatment within the past 5 years, or has a \>= 30% probability of recurrence within 24 months (except for non-melanoma skin cancer or Ta urothelial carcinomas)
• Chronically uncontrolled hypertension, defined conventionally as consistent systolic pressures above 170 or diastolic pressures above 110 despite anti-hypertensive therapy. Note that this is NOT a criterion related to particular blood pressure (BP) results at the time of assessment for eligibility, nor does it apply to acute BP excursions that are related to iatrogenic causes, acute pain or other transient, reversible causes. (For example doctor's visit related stress i.e. "white coat syndrome")
• Prolonged corrected QT interval by Fridericia's formula (QTcF) interval on pre-entry electrocardiogram (\>= 450 msec)
• Known active or symptomatic viral hepatitis or chronic liver disease
• Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsade de pointes), New York Heart Association class III-IV heart disease or cardiac ejection fraction measurement of \< 40% at baseline
• Patients who have had a history of illness which put them at current risk for bowel perforation such as acute diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction and abdominal carcinomatosis
• Baseline moderate and severe hepatic impairment (Child Pugh class B \& C)
• Seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 1 year to randomization, brain arteriovenous malformation, Schwannoma, meningioma, or other benign central nervous system \[CNS\] or meningeal disease which may require treatment with surgery or radiation therapy)
• Gastrointestinal disorder affecting absorption
• Untreated symptomatic spinal cord compression

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M Anderson Cancer Center

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Abiraterone Acetate; apalutamide; Prednisone; deltacortene; prednylidene

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienediols; Pregnadienes; Pregnanes

Study Officials

• Paul Corn

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2019
• First Posted: January 30, 2019
• Study Start: July 22, 2019
• Primary Completion (Estimated): October 11, 2026
• Study Completion (Estimated): October 11, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

US (1)