Using shockwave therapy to improve erectile function after prostate cancer surgery
Low-Intensity Extracorporeal Shockwave Therapy on Penile Rehabilitation After Robot-assisted Surgical Treatment of Genitourinary Cancers
This study is testing whether using shockwave therapy along with a common erectile dysfunction medication can help men regain erectile function better after prostate cancer surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 158 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Male |
| Sponsor | Regina Elena Cancer Institute Academic / other |
| Locations | 2 sites (Rome, RM and 1 other locations) |
| Trial ID | NCT06717711 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of Low-Intensity Extracorporeal Shock Wave Therapy (Li-ESWT) combined with PDE5 inhibitors in enhancing erectile function recovery in men who have undergone robot-assisted radical prostatectomy for prostate cancer. The study is a prospective randomized controlled trial that aims to compare the outcomes of patients receiving both treatments against those receiving PDE5 inhibitors alone. By focusing on early rehabilitation, the trial seeks to provide high-level evidence on the benefits of this combined approach in improving postoperative erectile function as measured by the International Index of Erectile Function-5 (IIEF-5).
Who should consider this trial
Good fit: Ideal candidates are men aged 18 to 75 years with prostate cancer who are undergoing nerve-sparing robotic surgery and have a preoperative IIEF-5 score of 17 or higher.
Not a fit: Patients with major postoperative complications, cardiovascular contraindications to PDE5 inhibitors, or those who have undergone pelvic radiotherapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve erectile function recovery in men after prostate cancer surgery.
How similar studies have performed: Previous studies have shown positive outcomes with PDE5 inhibitors in similar patient populations, but the combination with Li-ESWT is a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rome, RM and 1 other locations
- IRCCS "Regina Elena" National Cancer Institute — Rome, Rm, Italy (Recruiting)
- IRCCS "Fondazione G. Pascale" National Cancer Institute — Naples, Italy (Recruiting)
Study contacts
- Study coordinator: Giuseppe Simone
- Email: giuseppe.simone@ifo.it
- Phone: 0652665005
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.