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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07333976

Enrollment

Registered

2026-01-12

Start date

2020-01-05

Completion date

2024-08-13

Last updated

2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

tadalafil, docetaxel, Peripheral Neuropathy, Supportive Care, Prevention

Brief 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.

Interventions

DRUGTadalafil 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Incidence of Peripheral Neuropathy	From baseline up to the completion of 6 cycles of chemotherapy (approximately 12 weeks).	Defined as the proportion of patients developing sensory neuropathy Grade \> 1 according to NCI-CTCAE version 5.0 criteria.

Secondary

Measure	Time frame	Description
Incidence of Moderate to Severe Neuropathy	Up to 12 weeks.	Proportion of patients developing CTCAE Grade \> 2 sensory neuropathy (limiting instrumental activities of daily living).
Patient-Reported Neuropathy Symptoms (EORTC QLQ-CIPN20)	Assessed at baseline and before each chemotherapy cycle (every 2 weeks) up to 12 weeks.	Change from baseline in sensory and motor scores assessed by the EORTC QLQ-CIPN20 questionnaire. Scores range from 0 to 100, with higher scores indicating worse symptoms.
Oncological Efficacy (PSA Response)	Up to 12 weeks.	Percentage change in Prostate-Specific Antigen (PSA) levels from baseline to the end of treatment. This is a safety endpoint to ensure non-inferiority.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026