Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy Induced Peripheral Neuropathy (CIPN) | — | UNRESOLVED | — |
| Neurotoxicity | — | UNRESOLVED | — |
| Prostate Cancer Metastatic Disease | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tadalafil 5 mg | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Tadalafil Group (Experimental)
- description
- Patients receive Docetaxel chemotherapy plus Tadalafil.
- interventionNames
- Drug: Tadalafil 5 mg
- type
- NO_INTERVENTION
- label
- Control Group (No Intervention)
- description
- Patients receive Docetaxel chemotherapy with standard supportive care alone.
Primary outcomes (1)
- measure
- Incidence of Peripheral Neuropathy
- timeFrame
- From baseline up to the completion of 6 cycles of chemotherapy (approximately 12 weeks).
- description
- Defined as the proportion of patients developing sensory neuropathy Grade \> 1 according to NCI-CTCAE version 5.0 criteria.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available