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

Tri-Service General Hospital

Status and phase

Completed

Phase 2

Conditions

Chemotherapy Induced Peripheral Neuropathy (CIPN)

Neurotoxicity

Prostate Cancer Metastatic Disease

Treatments

Drug: Tadalafil 5 mg

Study type

Interventional

Funder types

Other

Identifiers

NCT07333976

2-107-05-167DIPN

Details and patient eligibility

About

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.

Enrollment

90 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histologically confirmed prostate adenocarcinoma.
Metastatic hormone-sensitive (mHSPC) or castration-resistant prostate cancer (mCRPC).
Scheduled to receive docetaxel chemotherapy (50 mg/m^2 biweekly).
ECOG performance status 0-2.
Adequate bone marrow, hepatic, and renal function.

Exclusion criteria

Pre-existing peripheral neuropathy (CTCAE grade >= 1).
Prior treatment with taxane-based chemotherapy.
Concurrent use of nitrates or nitric oxide donors.
Severe cardiovascular disease (e.g., unstable angina, recent myocardial infarction within 6 months).
Known hypersensitivity to tadalafil or PDE5 inhibitors.