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
Abstract
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.
Primary outcome: Incidence of Peripheral Neuropathy.
Enrollment: 90 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 90 participants or records.
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