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

NCT03360721 | Terminated Phase 2 FDA Drug

• 2 other identifiers: 2017-0060NCI-2018-01054
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies how well apalutamide and abiraterone acetate work in treating participants with castration resistant prostate cancer that has spread to other places in the body (metastatic). Abiraterone acetate and apalutamide may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunosuppressive therapy, such as prednisone, is used to decrease the body's immune response and may improve bone marrow function. Giving apalutamide, abiraterone acetate, and prednisone may work better in treating participants with castration resistant prostate cancer.

Conditions

Castration-Resistant Prostate Carcinoma; Prostate Adenocarcinoma Without Neuroendocrine Differentiation; Stage IV Prostate Cancer AJCC v8; Stage IVA Prostate Cancer AJCC v8; Stage IVB Prostate Cancer AJCC v8

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS)

  Will be assessed using primary analysis set (PAS). Kaplan-Meier curves will be presented.

  From enrollment until radiographic progression, death from any cause, start of other therapy or last follow-up without progression, whichever comes first assessed up to 28 months

Secondary Outcomes (6)

• Incidence of adverse events

  Up to 28 months

• Composite progression free survival (PFSc)

  From protocol treatment start until Prostate Cancer Working Group 2 (PCWG2) progression (radiographic progression, PSA progression, or clinical deterioration), death, starting new treatment or last follow-up without PCWG2 progression

• Overall survival (OS)

  Baseline until death or last contact, assessed up to 28 months

• Androgen expression signaling

  Baseline to week 13

• Survival escape pathway signaling

  Baseline to week 13

Study Arms (1)

Treatment (abiraterone acetate, apalutamide, prednisone)

EXPERIMENTAL

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.

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

Interventions

Abiraterone Acetate DRUG

Given PO

Also known as: CB7630, Yonsa, Zytiga

Treatment (abiraterone acetate, apalutamide, prednisone)

Apalutamide DRUG

Given PO

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

Treatment (abiraterone acetate, apalutamide, prednisone)

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, apalutamide, prednisone)

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 without neuroendocrine differentiation or small cell features
• 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 (i.e., surgical or medical castration)
• Serum testosterone level =\< 50 ng/dL at the screening visit
• Progressive disease defined as one or more of the following three criteria (NOTE: Patients who received an antiandrogen must demonstrate disease progression following discontinuation of antiandrogen):
• PSA progression defined by a minimum of two rising PSA levels with an interval of \>= 1 weeks between each determination. The PSA value at the screening visit should be \>= 2 ng/mL
• Soft tissue disease progression as defined by the Response Evaluation Criteria in Solid Tumors (RECIST)
• Bone disease progression defined by two or more new lesions on bone scan
• Patients previously treated with chemotherapy must have no more than two prior chemotherapy regimens for the treatment of metastatic prostate cancer
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• Serum albumin \>= 3.0 g/dL
• Serum potassium \>= 3.5 mmol/L
• Estimated life expectancy of \>= 6 months
• Able to swallow the study drug and comply with study requirements
• Willing and able to give informed consent

You may not qualify if:

• Known allergy to the study drugs or any of its components
• Severe, concurrent disease, infection, or co-morbidity that, in the judgment of the investigator, would make the patient inappropriate for enrollment or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated
• Known metastases to the brain
• Absolute neutrophil count \< 1000/uL at the screening visit
• Platelet count =\< 100,000 x 10\^9/uL at the screening visit
• Hemoglobin \< 9 g/dL at the screening visit at the screening visit
• NOTE: patients may not have received any growth factors or blood transfusions within seven days of the hematologic laboratory values obtained at the screening visit
• Total bilirubin (Tbili) \> 1.5 times the upper limit of normal at the screening visit
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2.5 times the upper limit of normal at the screening visit
• Creatinine (Cr) \> 2 mg/dL at the screening visit
• History of another malignancy within the previous 2 years with \> 30 % probability of relapse other than curatively treated non-melanomatous skin cancer
• Treatment with androgen receptor antagonists (bicalutamide, flutamide, nilutamide), 5-alpha reductase inhibitors (finasteride, dutasteride), estrogens, chemotherapy, or biologic therapy within 4 weeks of enrollment (day 1 visit)
• Radiation therapy within 3 weeks (if single fraction of radiotherapy within 2 weeks) of enrollment (day 1 visit)
• Planned palliative procedures for alleviation of bone pain such as radiation therapy or surgery
• Structurally unstable bone lesions suggesting impending fracture

Sponsors & Collaborators

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

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D 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

• Bagi Jana, MD

  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: November 28, 2017
• First Posted: December 4, 2017
• Study Start: March 6, 2018
• Primary Completion: March 12, 2026
• Study Completion: March 12, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

US (1)