NCT06931340View on ClinicalTrials.gov

Testing the Addition of Docetaxel (Chemotherapy) to the Usual Treatment (Hormonal Therapy and Apalutamide) for Metastatic Prostate Cancer, ASPIRE Trial

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

1,260

Participants

Timeline

Start Date

May 8, 2025

Primary Completion Date

November 11, 2031

Study Completion Date

May 8, 2039

Conditions
Castration-Sensitive Prostate CarcinomaMetastatic Prostate AdenocarcinomaStage IVB Prostate Cancer AJCC v8
Interventions
DRUG

Androgen Therapy

Given ADT

DRUG

Apalutamide

Given PO

DRUG

Docetaxel

Given IV

PROCEDURE

Computed Tomography

Undergo CT

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Bone Scan

Undergo Bone Scan

PROCEDURE

PSMA PET Scan

Undergo PSMA PET Scan

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

OTHER

Questionnaire Administration

undergo Questionnaire Administration

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Alliance for Clinical Trials in Oncology

OTHER