Prostate Cancer Metastatic DiseasePhase 2NCT07333976
o Tadalafil for Prevention of Docetaxel-Induced Peripheral Neuropathy in Prostate Cancer
A Phase 2 study testing Tadalafil 5 mg in people with Prostate Cancer Metastatic Disease and Chemotherapy Induced Peripheral Neuropathy (CIPN), run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer Metastatic Disease, Chemotherapy Induced Peripheral Neuropathy (CIPN), Neurotoxicity
- What is being tested?
- Tadalafil 5 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Jan 2020to 13 Aug 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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, Chemotherapy Induced Peripheral Neuropathy (CIPN), Neurotoxicity
- Being tested
- Tadalafil 5 mg
- Keywords
- tadalafil, docetaxel, Peripheral Neuropathy, Supportive Care, Prevention
- Medical subject headings
- Neurotoxicity Syndromes, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tadalafil 5 mgDrug
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 group | Role | What they receive |
|---|---|---|
| Tadalafil Group (Experimental) | Experimental | Patients receive Docetaxel chemotherapy plus Tadalafil. Receives: Drug: Tadalafil 5 mg |
| Control Group (No Intervention) | No intervention | Patients receive Docetaxel chemotherapy with standard supportive care alone. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Peripheral Neuropathy
Defined as the proportion of patients developing sensory neuropathy Grade > 1 according to NCI-CTCAE version 5.0 criteria.
Measured: From baseline up to the completion of 6 cycles of chemotherapy (approximately 12 weeks).
Secondary outcomes (3)
Incidence of Moderate to Severe Neuropathy
Proportion of patients developing CTCAE Grade > 2 sensory neuropathy (limiting instrumental activities of daily living).
Measured: Up to 12 weeks.
Patient-Reported Neuropathy Symptoms (EORTC QLQ-CIPN20)
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.
Measured: 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.
Measured: Up to 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start5 Jan 2020
- Primary completion22 Dec 2023
- Study completion13 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer Metastatic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MING-HSIN, YANG, Tri-Service General Hospital (TSGH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07333976
- Sponsor's protocol ID
- 2-107-05-167DIPN
- Status last verified
- Dec 2025
- First submitted
- 31 Dec 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07333976
- Acronym / sponsor ID
- 2-107-05-167DIPN
- Conditions
- Prostate Cancer Metastatic Disease, Chemotherapy Induced Peripheral Neuropathy (CIPN), Neurotoxicity
- Keywords
- tadalafil, docetaxel, Peripheral Neuropathy, Supportive Care, Prevention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- 5 Jan 2020 (actual)
- Primary completion
- 22 Dec 2023 (actual)
- Study completion
- 13 Aug 2024 (actual)
- First posted
- 12 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tadalafil Group (Experimental) | Experimental | Drug: Tadalafil 5 mgPatients receive Docetaxel chemotherapy plus Tadalafil. |
| Control Group (No Intervention) | No intervention | –Patients receive Docetaxel chemotherapy with standard supportive care alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tadalafil 5 mg5 mg administered orally on alternate days (every 48 hours), starting from the first day of chemotherapy cycle 1 until the completion of chemotherapy. | Drug | Tadalafil Group (Experimental) |
Primary outcome
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.
3 secondary outcomes
Incidence of Moderate to Severe Neuropathy
Time frame: Up to 12 weeks.
Patient-Reported Neuropathy Symptoms (EORTC QLQ-CIPN20)
Time frame: Assessed at baseline and before each chemotherapy cycle (every 2 weeks) up to 12 weeks.
Oncological Efficacy (PSA Response)
Time frame: Up to 12 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Prostate Cancer Metastatic Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
RecruitingPhase 2
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
Metastatic Castration-Resistant Prostate Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
Prostate Cancer, Prostate Adenocarcinoma
Active, not recruitingPhase 2
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Metastatic Castration-resistant Prostate Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tadalafil 5 mg in people with Prostate Cancer Metastatic Disease and Chemotherapy Induced Peripheral Neuropathy (CIPN), run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Peripheral Neuropathy (time frame: From baseline up to the completion of 6 cycles of chemotherapy (approximately 12 weeks).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.