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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tadalafil Group (Experimental) | Experimental | Patients receive Docetaxel chemotherapy plus Tadalafil. |
|
| Control Group (No Intervention) | No Intervention | Patients receive Docetaxel chemotherapy with standard supportive care alone. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Moderate to Severe Neuropathy | Proportion of patients developing CTCAE Grade > 2 sensory neuropathy (limiting instrumental activities of daily living). | Up to 12 weeks. |
| Patient-Reported Neuropathy Symptoms (EORTC QLQ-CIPN20) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tri-Service General Hospital | Taipei | Neihu | 114 | Taiwan |
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| ID | Term |
|---|---|
| D020258 | Neurotoxicity Syndromes |
| D010523 | Peripheral Nervous System Diseases |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D000068581 | Tadalafil |
| ID | Term |
|---|---|
| D002243 | Carbolines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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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.
| Assessed at baseline and before each chemotherapy cycle (every 2 weeks) up to 12 weeks. |
| Oncological Efficacy (PSA Response) | Percentage change in Prostate-Specific Antigen (PSA) levels from baseline to the end of treatment. This is a safety endpoint to ensure non-inferiority. | Up to 12 weeks. |
| D026121 |
| Indole Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |