NCT06717711 Low-Intensity Extracorporeal Shockwave Therapy on Penile Rehabilitation After Robot-assisted Surgical Treatment of Genitourinary Cancers
| NCT ID | NCT06717711 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Regina Elena Cancer Institute |
| Condition | Prostate Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 158 participants |
| Start Date | 2024-08-31 |
| Primary Completion | 2025-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 158 participants in total. It began in 2024-08-31 with a primary completion date of 2025-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06717711 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 75 Years, studying Prostate Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06717711 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 158 participants.
Is NCT06717711 currently recruiting?
Yes, NCT06717711 is actively recruiting participants. Contact the research team at giuseppe.simone@ifo.it for enrollment information.
Where is the NCT06717711 trial being conducted?
This trial is being conducted at Rome, Italy, Naples, Italy.
Who is sponsoring the NCT06717711 clinical trial?
NCT06717711 is sponsored by Regina Elena Cancer Institute. The trial plans to enroll 158 participants.