LiSWT for Nerve Sparing Radical Prostatectomy ED

Trial Title: LiSWT for Nerve Sparing Radical Prostatectomy ED

NCT ID: NCT05877144

Condition: Erectile Dysfunction
Localized Prostate Carcinoma
Stage I Prostate Cancer AJCC v8
Stage II Prostate Cancer AJCC v8
Stage III Prostate Cancer AJCC v8

Conditions: Official terms:
Prostatic Neoplasms
Erectile Dysfunction

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: No Data Available

Primary purpose: Treatment

Masking: None (Open Label)

Masking description: No Data Available

Intervention:

Intervention type: Procedure
Intervention name: Nerve-Sparing Prostatectomy
Description: Undergo nerve-sparing prostatectomy per standard of care
Arm group label: ARM I (LiSWT)

Other name: nerve-sparing radical prostatectomy

Other name: nerve-sparing surgery

Intervention type: Other
Intervention name: Medical Device Usage and Evaluation
Description: Receive LiSWT
Arm group label: ARM I (LiSWT)

Intervention type: Procedure
Intervention name: Duplex Ultrasound
Description: Undergo DDUS
Arm group label: ARM I (LiSWT)

Other name: DD

Other name: Duplex Doppler

Other name: Duplex Doppler Ultrasound

Intervention type: Other
Intervention name: Survey Administration
Description: Ancillary studies
Arm group label: ARM I (LiSWT)

Intervention type: Procedure
Intervention name: Nerve-Sparing Prostatectomy
Description: Undergo nerve-sparing prostatectomy per standard of care
Arm group label: ARM II (sham LiSWT)

Other name: nerve-sparing radical prostatectomy

Other name: nerve-sparing surgery

Intervention type: Procedure
Intervention name: Sham Intervention
Description: Receive sham LiSWT
Arm group label: ARM II (sham LiSWT)

Other name: Sham Comparator

Intervention type: Procedure
Intervention name: Duplex Ultrasound
Description: Undergo DDUS
Arm group label: ARM II (sham LiSWT)

Other name: DD

Other name: Duplex Doppler

Other name: Duplex Doppler Ultrasound

Intervention type: Other
Intervention name: Survey Administration
Description: Ancillary studies
Arm group label: ARM II (sham LiSWT)

Summary: This phase I clinical trial studies how well low intensity shockwave therapy (LiSWT) improves erectile function in patients who have had nerve-sparing radical prostatectomy (NS-RP), a type of surgery that attempts to save the nerves near the tissues being removed, for prostate cancer. Erectile dysfunction (ED) is a known side effect of the radical prostatectomy procedure. The low intensity shockwave therapy delivers painless electrotherapy pulse to increase blood flow and supply, activation of tissues and wound healing. Using LiSWT after NS-PRP may improve erectile function in men with prostate cancer.

Detailed description: PRIMARY OBJECTIVE: I. To determine whether LiSWT following nerve-sparing radical prostatectomy (NS-RP) improves outcomes in men with erectile dysfunction (ED) supported by cGMP phosphodiesterase inhibitor (PDE5i) medication. SECONDARY OBJECTIVES: I. To determine whether LiSWT improves duplex doppler ultrasound (DDUS) flow parameters at 6 months following LiSWT treatment. II. To determine the postoperative durability of any beneficial outcome of LiWST treatment to erectile function. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo nerve-sparing radical prostatectomy per standard of care. Patients then receive LiSWT treatment weekly for 6 weeks, then have a 6 week break, followed by 6 more weekly treatments. Patients also undergo DDUS at baseline and during follow up. ARM II: Patients undergo nerve-sparing radical prostatectomy per standard of care. Patients then receive sham LiSWT treatment weekly for 6 weeks, then have a 6 week break, followed by 6 more weekly treatments. Patients also undergo DDUS at baseline and during follow up.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Provide signed and dated informed consent form - Willing to comply with all study procedures and be available for the duration of the study - Men aged 18-80 diagnosed with localized prostate cancer - Score 12 or higher on the pre-operative International Index of Erectile Function (IIEF) assessment - Undergo the nerve-sparing radical prostatectomy procedure - Be taking PDE5i medication for the entirety of the study (normal course of care) - Be in a sexual relationship with a partner for at least 3 months - Be willing to attempt sexual activity during the screening period and before each follow-up visit - Be willing to stop all erectile aids (e.g. prescription and non-prescription erectile medications not part of this study, penile injections, vacuum erection devices, constriction rings) during the screening and study period Exclusion Criteria: - • Subject does not speak or understand English - Subject has been treated with acoustic wave previously - Subject has had prior penile surgery - Patients with pacemakers or implantable defibrillators - Patients who are using devices which are sensitive to electromagnetic radiation - Patients who are found to have metastatic disease and require radiation/hormone therapy before initiation of shockwave/sham treatments - Subject has lesions or active infections on the penis or perineum - Subject is unwilling to remove piercings from the genital region - Subject has a history of substance abuse within 12 months prior, or consuming > 14 alcoholic drinks per week - Subject has received an investigational drug within 30 days prior to signing consent - Subject has received platelet-rich plasma (PRP) within 3 months of signing consent - Subject has received stem cell within 6 months of signing consent - Subject has any condition or exhibits behavior that indicates to the principle investigator (PI) that the subject is unlikely to be compliant with study procedures and visits - Cognitively/decisionally-impaired individuals

Gender: Male

Gender based: Yes

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Locations:

Facility:
Name: Sidney Kimmel Cancer Center at Thomas Jefferson University

Address:
City: Philadelphia
Zip: 19107
Country: United States

Status: Recruiting

Contact:
Last name: Paul Chung, MD

Phone: 215-955-6961
Email: Paul.Chung@jefferson.edu

Start date: July 6, 2023

Completion date: April 2025

Lead sponsor:
Agency: Thomas Jefferson University
Agency class: Other

Source: Thomas Jefferson University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05877144