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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05877144.
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.
Trial PhasePhase I
Trial Typesupportive care
Lead OrganizationThomas Jefferson University Hospital
Principal InvestigatorPaul H. Chung
