EAU-EANM-ESTRO-ESUR-SIOG Guidelines on Prostate Cancer-2020 Update. Part 1: Screening, Diagnosis, and Local Treatment with Curative Intent.
Nicolas Mottet, Roderick C N van den Bergh, Erik Briers...
https://pubmed.ncbi.nlm.nih.gov/33172724Actively Recruiting
Phase 3
Age: 18Years - 75Years
MALE
ID06717711
Low-Intensity Extracorporeal Shockwave Therapy Combined with PDE5 Inhibitors for Penile Rehabilitation After Robot-Assisted Surgery for Genitourinary Cancers
Led by Regina Elena Cancer Institute ยท Updated on 2024-12-05
158
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of Low-intensity Extracorporeal Shock Wave Therapy (Li-ESWT) combined with PDE5 inhibitors (PDE5i) compared to PDE5i alone for treating erectile dysfunction (ED) after Robot-Assisted Radical Prostatectomy (RARP). Erectile dysfunction is a common complication following this surgery, and this trial aims to provide strong evidence on whether adding Li-ESWT can improve recovery of erectile function measured by the International Index of Erectile Function-5 (IIEF-5) score. Participants are randomly assigned to one of two groups: one receiving Li-ESWT plus early PDE5i treatment, and the other receiving PDE5i alone. The PDE5i used is tadalafil at 5 mg daily, starting after catheter removal around 7 to 10 days post-surgery. Li-ESWT is given over six weeks starting approximately 52 days after surgery, using a device that applies focused shock waves to the erectile tissue. The treatment sessions involve 12,000 shocks delivered in a precise manner to promote tissue remodeling. During the study, participants' erectile function is assessed using IIEF-5 and Erectile Hardness Scores (EHS) before surgery and at multiple follow-up visits up to one year after surgery. Additional assessments include urinary continence, adverse effects, and quality of life questionnaires. At one year, PDE5i treatment is paused for two weeks to evaluate erectile function without medication. Safety and treatment effects will be monitored throughout the study period, which lasts approximately one year from enrollment.
CONDITIONS
Brief Title
Low-Intensity Extracorporeal Shockwave Therapy on Penile Rehabilitation After Robot-assisted Surgical Treatment of Genitourinary Cancers
Who Can Participate
Age: 18Years - 75Years
MALE
Eligibility Criteria
You may qualify if you...
- Male patients aged 18 to 75 years
- PSA less than 10 ng/mL
- Prostate Cancer ISUP grade 2 or lower and clinical stage cT2 or lower at biopsy
- Undergoing nerve-sparing Robot-Assisted Radical Prostatectomy
- Preoperative International Index of Erectile Function-5 (IIEF-5) score of 17 or higher
- First PSA measurement 45 days after surgery less than 0.1
- Final pathology showing Prostate Cancer ISUP grade 2 or lower and pathological stage less than pT3b
- Able to follow study protocol and complete IIEF-5 and quality of life questionnaires
- Able to provide written informed consent for the trial
You will not qualify if you...
- Contraindications to anesthesia for robotic surgery
- Previous pelvic radiotherapy or androgen deprivation therapy
- Major postoperative complications classified as Clavien-Dindo grade 3 or higher
- Cardiovascular contraindications to PDE5 inhibitor treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - From surgery to 1 year after treatment
Participants receive robot-assisted radical prostatectomy followed by early introduction of PDE5 inhibitors. Participants in the experimental group also receive low-intensity extracorporeal shockwave therapy (LiESWT) starting approximately 7 weeks after surgery.
Weekly visits for up to 6 weeks during LiESWT plus regular follow-up visits for PDE5i treatment and assessments
Follow-up
Duration - Up to 1 year after treatment
Participants are monitored for erectile function, urinary continence, adverse effects, and health-related quality of life up to 1 year after treatment. After 1 year, PDE5 inhibitors are paused for 2 weeks to assess erectile function without medication.
Follow-up visits at 3, 6, and 12 months post-surgery
Trial Site Locations
Total: 2 locations
1
IRCCS "Regina Elena" National Cancer Institute
Rome, RM, Italy, 00144
Actively Recruiting
2
IRCCS "Fondazione G. Pascale" National Cancer Institute
Naples, Italy, 80131
Actively Recruiting
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Research Team
G
Giuseppe Simone
R
Riccardo Mastroianni
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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J L Donovan, F C Hamdy, J A Lane...
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