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

StatusRecruiting
PhasePhase 3
Started2025-12-01
View on ClinicalTrials.gov ↗

Amendment history

2026-09-01
minor
Study Status, Contacts/Locations v10
Trial sites expanded: 200 → 210 locations
2026-08-04
minor
Study Status, Contacts/Locations v9
Trial sites expanded: 195 → 200 locations
2026-07-01
minor
Study Status, Contacts/Locations v8
Study sites194→195
2026-06-01
minor
Study Status, Contacts/Locations v7
Trial sites expanded: 186 → 194 locations
2026-05-07
minor
Study Status, Contacts/Locations v6
Trial sites expanded: 177 → 186 locations
2026-04-06
minor
Study Status, Contacts/Locations v5
Trial sites expanded: 150 → 177 locations
2026-03-02
minor
Study Status, Contacts/Locations v4
Study sites125→150
2026-02-03
minor
Study Status, Contacts/Locations v3
Start dateestimated 2025-11-08→confirmed 2025-12-01
Study sites27→125
2025-11-04
minor
Study Status, Contacts/Locations v2
Study sites9→27
2025-10-24
notable
Not Yet Recruiting→Recruiting Study Identification, Study Status, Oversight, Eligibility, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start date2025-05-08→2025-11-08
Study sites0→9
2025-04-09
minor
Original filing
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.
Trial Details
NCT Number NCT06931340
Lead Sponsor Alliance for Clinical Trials in Oncology
Collaborators: National Cancer Institute (NCI)
Conditions Castration-Sensitive Prostate Carcinoma, Metastatic Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8
Enrollment 1,260 participants
Start Date 2025-12-01
Primary Completion 2031-11-11 (estimated)
Study Completion 2039-05-08 (estimated)
Updated on ClinicalTrials.gov 2026-09-02