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Completed

NCT Number: NCT07333976

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

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.

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Key information

Conditions

Prostate Cancer Metastatic Disease Chemically-Induced Disorders Chemotherapy Induced Peripheral Neuropathy (CIPN) Nervous System Diseases Neuromuscular Diseases Neurotoxicity Neurotoxicity Syndromes Peripheral Nervous System Diseases Poisoning

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Tri-Service General Hospital

Taipei, Neihu, 114, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Incidence of Peripheral Neuropathy

    Time frame: 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 outcomes

  1. Incidence of Moderate to Severe Neuropathy

    Time frame: Up to 12 weeks.

    Proportion of patients developing CTCAE Grade > 2 sensory neuropathy (limiting instrumental activities of daily living).

  2. Patient-Reported Neuropathy Symptoms (EORTC QLQ-CIPN20)

    Time frame: 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.

  3. Oncological Efficacy (PSA Response)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Tri-Service General Hospital (TSGH)

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Jan 12, 2026
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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