Shockwave Therapy for Erections After Robotic Surgery for Prostate Cancer
Tests shockwave therapy with tadalafil in adults recovering erectile function after prostate cancer surgery.
Key facts
- Who runs it
- Regina Elena Cancer Institute
- Where
- Naples and Rome, ItalySee the 2 sites
- Trial code
- Registry title
- Low-Intensity Extracorporeal Shockwave Therapy on Penile Rehabilitation After Robot-assisted Surgical Treatment of Genitourinary Cancers
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 158 people, planned
- Started
- 15 Sept 2023
- Expected to end
- 28 Feb 2028
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Low-intensity Extracorporeal Shock Wave Therapy (LiESWT)
- PDE5 inhibitor (tadalafil)
- Record updated
- 14 August 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men aged 18 to 75 who have prostate cancer and are having nerve-sparing robot-assisted prostate surgery. It tests shockwave therapy plus PDE5 inhibitor tablets against tablets alone to help erections recover.
- Age
- 18 to 75 years
- Sex
- Men only
- Disease stage
- Prostate cancer with ISUP grade 2 or lower and cT 2 or lower at biopsy, and ISUP grade 2 or lower and pT below 3b at final pathology. PSA below 10 ng/mL.
- Earlier treatment
- Must be having nerve-sparing robot-assisted radical prostatectomy. Cannot have had pelvic radiotherapy or androgen deprivation.
- Biomarker or test result
- IIEF-5 score of 17 or more before surgery. First PSA 45 days after surgery below 0.1.
Main reasons for not taking part
- Reasons that make robotic surgery unsafe under anaesthesia
- Pelvic radiotherapy or androgen deprivation
- Major complications after surgery (CD 3 or higher)
- Heart or blood vessel reasons that rule out PDE5 inhibitor treatment
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Where in Italy
- IRCCS "Fondazione G. Pascale" National Cancer InstituteNaples, ItalyContact: Sisto PerdonàTaking people
- IRCCS Regina Elena National Cancer InstituteRome, ItalyContact: Giuseppe SimoneTaking people
About the trial
What the trial wants to find out
This prospective randomized controlled trial (RCT) is designed to provide high level evidence on the efficacy of Low-intensity Extracorporeal Shock Wave Therapy (Li-ESWT) in the treatment of post-Robot-Assisted (RA) Radical Prostatectomy (RP) erectile dysfunction (ED) in addition to PDE5 inhibitors (PDE5i) versus PDE5i alone. Our hypothesis is that early andrological rehabilitation that combines Li-ESWT and PDE5i could lead to faster and better recovery of valid erections for intercourse, with a greater rate of postoperative International Index of Erectile Function-5 (IIEF-5) compared to patients receiving PDE5i alone.
The 2 groups in the trial
- PDE5i + LiESWTTreatment being tested
Patients receiving LiESWT plus early introduction of PDE5i
Treatment: Low-intensity Extracorporeal Shock Wave Therapy (LiESWT) and PDE5 inhibitor (tadalafil)
- PDE5i aloneExisting treatment, for comparison
Control group, patients receiving PDE5i alone
Treatment: PDE5 inhibitor (tadalafil)
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Low-Intensity Extracorporeal Shockwave Therapy on Penile Rehabilitation After Robot-assisted Surgical Treatment of Genitourinary Cancers
- Plain-language title
- Shockwave Therapy for Erections After Robotic Surgery for Prostate CancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06717711, who can take part
- Record updated
- 14 August 2026