Docetaxel Addition in Metastatic Castrate-Sensitive Prostate Cancer (ASPIRE)
Alliance for Clinical Trials in Oncology
Summary
This phase III trial compares the effect of adding docetaxel to hormonal therapy and apalutamide versus hormonal therapy and apalutamide alone in treating patients with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Docetaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Hormone therapy for prostate cancer, also called androgen deprivation therapy (ADT), uses surgery or drugs to lower the levels of male sex hormones in a man's body. This helps slow the growth of prostate cancer. Apalutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of tumor cells. Giving docetaxel in addition to the usual treatment of hormonal therapy and apalutamide may work better in treating patients with metastatic prostate cancer than the usual treatment alone.
Description
PRIMARY OBJECTIVE: I. To determine if the addition of docetaxel to androgen deprivation therapy and apalutamide improves overall survival for men with metastatic castrate sensitive prostate cancer. SECONDARY OBJECTIVES: I. To determine if the addition of docetaxel to androgen deprivation therapy and apalutamide improves overall survival for men whose cancers have loss or inactivating mutations of TP53, PTEN, or RB1. II. To determine if the addition of docetaxel to ADT plus apalutamide improves the time to radiographic progression per Prostate Cancer Working Group 3 (PCWG3) guidelines. III…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * Documentation of disease: \* Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell histology * Must have had evidence of metastatic disease (American Joint Committee on Cancer \[AJCC\] metastasis \[M\]1 disease) based on conventional CT/MRI and/or bone scan. This will be defined as: * Bone metastases detected by CT, radionuclide technetium-99 (99Tc)- methylene bisphosphonate bone scan, or MRI as defined by PCWG3 criteria; OR * Non-pelvic lymph node metastases (measurable lymph nodes above the aortic bifurcation; lymph nodes a…
Interventions
- DrugAndrogen Therapy
Given ADT
- DrugApalutamide
Given PO
- DrugDocetaxel
Given IV
- ProcedureComputed Tomography
Undergo CT
- ProcedureMagnetic Resonance Imaging
Undergo MRI
- ProcedureBone Scan
Undergo Bone Scan
- ProcedurePSMA PET Scan
Undergo PSMA PET Scan
Locations (186)
- Banner University Medical Center - TucsonTucson, Arizona
- University of Arizona Cancer Center-North CampusTucson, Arizona
- Kaiser Permanente DublinDublin, California
- Kaiser Permanente-FremontFremont, California
- Kaiser Permanente Fresno Orchard PlazaFresno, California
- UC San Diego Moores Cancer CenterLa Jolla, California