Low-Intensity Extracorporeal Shockwave Therapy on Penile Rehabilitation After Robot-assisted Surgical Treatment of Genitourinary Cancers

NCT06717711 | Recruiting Phase 3 DMC

• 1 other identifier: PNRR-MCNT2-2023-12377570
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 2

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.

Conditions

Prostate Carcinoma; Erectile Function; Genito Urinary Cancer

Keywords

prostate cancer; erectile function; rehabilitation; genitourinary cancers

Outcome Measures

Primary Outcomes (1)

• Erectile Function

  To investigate the impact of LiESWT in combination with early PDE5i administration versus early PDE5i alone on the penile rehabilitation of erectile dysfunction (ED) after RARP

  From enrollment to 1 year after treatment

Secondary Outcomes (3)

• Urinary Continence

  From enrollment to 1 year after treatment

• Adverse effects

  From enrollment to 1 year after treatment

• Health Related Quality of Life

  From enrollment to 1 year after treatment

Study Arms (2)

PDE5i + LiESWT

EXPERIMENTAL

Patients receiving LiESWT plus early introduction of PDE5i

Device: Low-intensity Extracorporeal Shock Wave Therapy (LiESWT); Drug: PDE5 inhibitor (tadalafil)

PDE5i alone

ACTIVE COMPARATOR

Control group, patients receiving PDE5i alone

Drug: PDE5 inhibitor (tadalafil)

Interventions

Low-intensity Extracorporeal Shock Wave Therapy (LiESWT) DEVICE

LiESWT will be performed with PiezoWave2 from Richard Wolf and ELvation® Medical. In a single session 12,000 shocks with an energy flux density of 0.16 mJ/mm2 will be applied (4,000 over the crura of the penis and 8,000 to the penil shaft). The penis is placed in a dedicated penile holder, stretched, and shockwaves are administered with a linear therapy source (applicator) using the linear shockwave tissue coverage (LSTC-ED®) technique which makes it possible to administer shockwaves homogenously to all of the erectile tissue.

PDE5i + LiESWT

PDE5 inhibitor (tadalafil) DRUG

Phosphodiesterase-5 (PDE5) inhibitors

PDE5i + LiESWT; PDE5i alone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Regina Elena Cancer Institute: lead

Study Sites (2)

IRCCS "Regina Elena" National Cancer Institute

Rome, RM, 00144, Italy

RECRUITING

IRCCS "Fondazione G. Pascale" National Cancer Institute

Naples, 80131, Italy

RECRUITING

Related Publications (19)

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MeSH Terms

Conditions

Prostatic Neoplasms; Urogenital Neoplasms

Interventions

Phosphodiesterase 5 Inhibitors; Tadalafil

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Intervention Hierarchy (Ancestors)

Phosphodiesterase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Central Study Contacts

Giuseppe Simone

CONTACT

0652665005; giuseppe.simone@ifo.it

Riccardo Mastroianni

CONTACT

0652665005; riccardo.mastroianni@ifo.it

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 30, 2024
• First Posted: December 5, 2024
• Study Start: August 31, 2024
• Primary Completion: August 31, 2025
• Study Completion (Estimated): August 31, 2026
• Last Updated: December 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)