NCT04267887

Advanced ChemoHormonal Therapy for Treatment Naive Metastatic Prostate Cancer

Advanced ChemoHormonal Therapy for Treatment Naïve Metastatic Prostate Cancer: Apalutamide and Abiraterone Acetate With Prednisone and Androgen Deprivation Therapy After Treatment With Docetaxel and Androgen Deprivation Therapy

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: OHSU Knight Cancer Institute · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well the combination of apalutamide, abiraterone acetate, and prednisone after chemotherapy work in treating patients that have received no prior treatment (treatment naive) for high risk prostate cancer that is sensitive to androgen deprivation therapy (castration sensitive) and has spread to other parts of the body (metastatic). This study also aims to understand the inheritance of prostate cancer. If a gene or genes that cause prostate cancer can be found, the diagnosis and treatment of prostate cancer may be improved. Testosterone (a male hormone) can cause the growth of prostate cancer cells. Hormone therapy using apalutamide may fight prostate cancer by blocking the use of testosterone by the tumor cells. Antihormone therapy, such as abiraterone acetate, may lessen the amount of testosterone made by the body. Anti-inflammatory drugs such as prednisone lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Apalutamide, abiraterone acetate, and prednisone after chemotherapy may work better in treating patients with castration sensitive prostate cancer.

Detailed description

PRIMARY OBJECTIVE: I. Efficacy of apalutamide in combination with abiraterone acetate + prednisone following docetaxel with ongoing androgen deprivation therapy in men with high risk metastatic castration sensitive disease. SECONDARY OBJECTIVES: I. Safety and tolerability of apalutamide in combination with abiraterone acetate + prednisone following docetaxel with ongoing androgen deprivation therapy. II. Time to event. III. Depth of prostate specific antigen (PSA) response. EXPLORATORY OBJECTIVES: I. Quality of life. II. Falls. III. Molecular changes from prostate cancer over time. OUTLINE: Patients receive apalutamide orally (PO) once daily (QD), abiraterone acetate PO QD, and prednisone PO QD. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive androgen deprivation therapy per standard of care. Patients undergo computed tomography (CT) scan, bone scan and blood sample collection throughout the study. After completion of study treatment, patients are followed up every 6 months for up to 10 years.

Conditions

• Castration-Sensitive Prostate Carcinoma
• Metastatic Prostate Carcinoma
• Stage IVB Prostate Cancer AJCC v8

Interventions

Type	Name	Description
DRUG	Abiraterone Acetate	Given PO
DRUG	Antiandrogen Therapy	Given ADT per standard of care
DRUG	Apalutamide	Given PO
DRUG	Prednisone	Given PO
PROCEDURE	Computed Tomography	Undergo CT scan
PROCEDURE	Bone Scan	Undergo bone scan
PROCEDURE	Biospecimen Collection	Undergo blood sample collection
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2020-05-11
• Primary completion: 2028-01-01
• Completion: 2030-01-01
• First posted: 2020-02-13
• Last updated: 2026-01-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study