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Could a common ED drug shield prostate cancer patients from chemo nerve pain?

NCT ID NCT07333976

Prevention Sponsor: Tri-Service General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether tadalafil, a drug often used for erectile dysfunction, can prevent nerve damage caused by docetaxel chemotherapy in men with metastatic prostate cancer. 90 participants were randomly assigned to receive either tadalafil plus standard care or standard care alone. The goal was to see if tadalafil reduces the number of patients who develop painful or limiting nerve symptoms during treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

90 people

The number who actually took part.

Started

Jan 2020

Finished

Aug 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

metastatic prostate carcinoma peripheral nervous system disorder toxic encephalopathy chemotherapy-induced neuropathy prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chemotherapy induced peripheral neuropathy (CIPN) Neurotoxicity Prostate cancer metastatic disease

Contacts and locations

Locations

  • Tri-Service General Hospital

    Taipei, Neihu, 114, Taiwan

More trials for these conditions

Other studies related to the condition(s) this trial covers.