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

NCT07333976 | Completed Phase 2 DMC

• 1 other identifier: 2-107-05-167DIPN
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

tadalafil; docetaxel; Peripheral Neuropathy; Supportive Care; Prevention

Outcome Measures

Primary Outcomes (1)

• Incidence of Peripheral Neuropathy

  Defined as the proportion of patients developing sensory neuropathy Grade \> 1 according to NCI-CTCAE version 5.0 criteria.

  From baseline up to the completion of 6 cycles of chemotherapy (approximately 12 weeks).

Secondary Outcomes (3)

• Incidence of Moderate to Severe Neuropathy

  Up to 12 weeks.

• Patient-Reported Neuropathy Symptoms (EORTC QLQ-CIPN20)

  Assessed at baseline and before each chemotherapy cycle (every 2 weeks) up to 12 weeks.

• Oncological Efficacy (PSA Response)

  Up to 12 weeks.

Study Arms (2)

Tadalafil Group (Experimental)

EXPERIMENTAL

Patients receive Docetaxel chemotherapy plus Tadalafil.

Drug: Tadalafil 5 mg

Control Group (No Intervention)

NO INTERVENTION

Patients receive Docetaxel chemotherapy with standard supportive care alone.

Interventions

Tadalafil 5 mg DRUG

5 mg administered orally on alternate days (every 48 hours), starting from the first day of chemotherapy cycle 1 until the completion of chemotherapy.

Tadalafil Group (Experimental)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tri-Service General Hospital: lead

Study Sites (1)

Tri-Service General Hospital

Taipei, Neihu, 114, Taiwan

Location

MeSH Terms

Conditions

Neurotoxicity Syndromes; Peripheral Nervous System Diseases

Interventions

Tadalafil

Condition Hierarchy (Ancestors)

Nervous System Diseases; Poisoning; Chemically-Induced Disorders; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DR.

Study Record Dates

• First Submitted: December 31, 2025
• First Posted: January 12, 2026
• Study Start: January 5, 2020
• Primary Completion: December 22, 2023
• Study Completion: August 13, 2024
• Last Updated: January 12, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)