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Shockwaves may speed up erectile recovery after prostate cancer surgery

NCT ID NCT06717711

Disease control Sponsor: Regina Elena Cancer Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 14, 2026 · Last updated Aug 14, 2026

Summary

This phase 3 trial is testing whether adding low-intensity shockwave therapy to standard erectile dysfunction pills helps men recover erectile function more effectively after robotic prostate cancer surgery. The study involves 158 men who have undergone nerve-sparing surgery and have good erectile function beforehand. Half will receive shockwave therapy plus pills, while the other half will receive pills alone. The goal is to see if the combination leads to better erectile function and quality of life within a year after surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Low-intensity extracorporeal shock wave therapy (LiESWT) using a device called PiezoWave2, given alongside PDE5 inhibitor pills
What this could lead to
If effective, this combination could help men recover erectile function faster and more fully after prostate cancer surgery, improving quality of life.
What could go wrong
The trial is still testing the approach, and results may not be conclusive. There is also a risk of minor side effects from the shockwave therapy, though serious complications are unlikely.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 158 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2023

Expected to finish

Feb 2028

An estimate. End dates often move.

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 to 75 years

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: * Patients aged ≤75 yrs; * PSA \<10 ng/mL * Prostate Cancer ISUP grade ≤2 and cT≤2 at prostate biopsy * undergoing nerve sparing RARP; * preoperative IIEF-5 score ≥ 17; * First PSA (45d after surgery) \<0.1 * Prostate Cancer ISUP grade ≤2 pT\<3b and at final pathology * ≥ 18 yrs old; * compliants patients able to follow the study protocol and fill in IIEF-5 scores and EORTC quality of life questionnaires; * patients able to provide a written informed consent for the trial. Exclusion Criteria: * anaesthesiologic contraindications to robotic surgery * patients submitted to pelvic radiotherapy or androgen deprivation * patients reporting major postoperative complications (CD≥3) * cardiovascular contraindications to PDE5i medical treatment

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Conditions

The condition(s) this trial relates to.

erectile dysfunction prostate cancer prostate carcinoma Urogenital Neoplasms

As listed by the trial registrant

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

Erectile function Genito-urinary cancer Prostate carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • IRCCS "Fondazione G. Pascale" National Cancer Institute

    RECRUITING

    Naples, 80131, Italy

  • IRCCS "Regina Elena" National Cancer Institute

    RECRUITING

    Rome, RM, 00144, Italy

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