NCT07333976

o Tadalafil for Prevention of Docetaxel-Induced Peripheral Neuropathy in Prostate Cancer

o A Prospective, Randomized, Open-Label, Phase II Study Evaluating the Efficacy of Tadalafil for the Prevention of Docetaxel-Induced Peripheral Neuropathy in Patients With Metastatic Prostate Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Tri-Service General Hospital · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Docetaxel is a standard chemotherapy for metastatic prostate cancer but is associated with dose-limiting peripheral neuropathy. Currently, no pharmacologic agents are established for prevention. Tadalafil, a PDE5 inhibitor, may improve microvascular perfusion and offer neuroprotection. This randomized phase II trial evaluates whether concurrent use of tadalafil (5 mg every 2 days) reduces the incidence and severity of docetaxel-induced peripheral neuropathy compared to standard care in patients with metastatic prostate cancer.

Conditions

• Prostate Cancer Metastatic Disease
• Chemotherapy Induced Peripheral Neuropathy (CIPN)
• Neurotoxicity

Interventions

Type	Name	Description
DRUG	Tadalafil 5 mg	5 mg administered orally on alternate days (every 48 hours), starting from the first day of chemotherapy cycle 1 until the completion of chemotherapy.

Timeline

• Start date: 2020-01-05
• Primary completion: 2023-12-22
• Completion: 2024-08-13
• First posted: 2026-01-12
• Last updated: 2026-01-12

Locations

1 site across 1 country: Taiwan