Using shockwave therapy to improve erectile function after prostate cancer surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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).

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Understanding NK Cell Function in Prostate Cancer Across Races

  This study tests whether natural killer (NK) cells behave differently in prostate cancer patients of diverse racial backgrounds by analyzing blood and tissue samples.

  Recruiting Masonic Cancer Center, University of Minnesota · Minneapolis, Minnesota · NCT07910019

• MRI or CT planning to guide high-dose-rate prostate brachytherapy

  This trial tests whether adding an MRI to CT-based treatment planning for HDR prostate brachytherapy changes urinary side effects in men with localized prostate cancer.

  Recruiting at 3 sites Emory University · Atlanta, Georgia and 2 other locations · NCT07859722

• Nerve-Sparing Robotic Prostatectomy: How Baseline Health Affects Post-Surgery Erections

  Researchers will test whether a patient’s age, health history, and pre-surgery sexual function can predict erectile function after nerve-sparing robot-assisted prostatectomy.

  Recruiting University of Florence · Florence, Italy · NCT07747272

• Targeted Early Detection for Men at High Genetic Risk for Prostate Cancer

  This study tests urinary biomarkers and PSA to see if they can improve early detection for men with a strong family or genetic risk for prostate cancer.

  Recruiting University of Michigan Rogel Cancer Center · Ann Arbor, Michigan · NCT07645391

• Intraurethral Alprostadil Paste for Erectile Dysfunction: Dose-Escalation Study

  A 12-week, dose-escalation study tests a new alprostadil paste applied inside the urethra to see if it improves erections in men with ED who have not benefited from PDE5 inhibitors.

  Recruiting Phase 2 University of British Columbia · Vancouver, British Columbia · NCT07601646

• Urine and MRI approach to find aggressive prostate cancer early

  This study tests whether a urine test called MPS2, paired with MRI, can better detect aggressive prostate cancer in men 50–75 at risk, possibly reducing unnecessary biopsies.

  Recruiting University of Michigan Rogel Cancer Center · Ann Arbor, Michigan · NCT07526545

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.