OncoMatch/Clinical Trials/NCT06931340
Testing the Addition of Docetaxel (Chemotherapy) to the Usual Treatment (Hormonal Therapy and Apalutamide) for Metastatic Prostate Cancer, ASPIRE Trial
Is NCT06931340 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Androgen Therapy and Apalutamide for castration-sensitive prostate carcinoma.
Treatment: Androgen Therapy · Apalutamide · Docetaxel — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Disease stage
Required: Stage IVB
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: LHRH agonist/antagonist or orchiectomy
ADT (luteinizing hormone-releasing hormone [LHRH] agonist/antagonist or orchiectomy) with or without first generation anti-androgen, or second-generation androgen receptor signaling inhibitor (ARSI) within 120 days of registration is permitted
Cannot have received: chemotherapy
No prior chemotherapy for prostate cancer
Lab requirements
Blood counts
ANC ≥ 1,500/mm^3; Hemoglobin ≥ 9.0 g/dL; Platelet count ≥ 100,000/mm^3
Kidney function
Calculated creatinine clearance > 30 mL/min
Liver function
Total bilirubin ≤ 1 x upper limit of normal (ULN); AST/ALT ≤ 1.5 x ULN
Cardiac function
NYHA class II or better; clinical risk assessment required for patients with history or symptoms of cardiac disease or prior cardiotoxic agents
ANC ≥ 1,500/mm^3; Hemoglobin ≥ 9.0 g/dL; Platelet count ≥ 100,000/mm^3; Total bilirubin ≤ 1 x ULN; AST/ALT ≤ 1.5 x ULN; Calculated creatinine clearance > 30 mL/min; Serum potassium ≥ 3.5 mmol/L; NYHA class II or better
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Saint Francis Medical Center · Cape Girardeau, Missouri
- Community Hospital of Anaconda · Anaconda, Montana
- Billings Clinic Cancer Center · Billings, Montana
- Bozeman Health Deaconess Hospital · Bozeman, Montana
- Benefis Sletten Cancer Institute · Great Falls, Montana
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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