NCT07333976CompletedPhase 2
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 · Last updated 12 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 90 (actual)
- First submitted
- 31 Dec 2025
- Start date
- Jan 2020
- Primary completion date
- Dec 2023
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Diseases
- Prostate cancer
- NCT number
- NCT07333976
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 90
- From Jan 2020 to the primary completion date, Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with taxane-based chemotherapy.
- Concurrent use of nitrates or nitric oxide donors.
Other illness
- Severe cardiovascular disease (e.g., unstable angina, recent myocardial infarction within 6 months).
- Known hypersensitivity to tadalafil or PDE5 inhibitors.
Other
- Pre-existing peripheral neuropathy (CTCAE grade \>= 1).
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tri-Service General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.