Periprostatic Neurolysis in Prostate Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity of Texas Southwestern Medical Center
About this trial
The purpose of this research study is to assess whether inhibiting nerve activity to the prostate delays progression of disease in men with high-risk clinical features for prostate cancer. Prostate cancer has been shown to invade nerves, a mechanism that is thought to be involved in prostate cancer spread in men with high-risk cancer. When nerve activity to the prostate is blocked in mice with prostate cancer, prostate cancer growth and spread are inhibited. In a previous study we showed that doing so in humans was safe and may have anticancer therapeutic effect. In this study we will test whether one versus two injections of nerve blocking agent is more effective at reducing nerves in the prostate and whether it will slow/stop spread of prostate cancer after treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Periprostatic neurolysis with dehydrated alcohol (ethanol)
Procedure/SurgeryPre-operative ultrasound guided periprostatic neurolysis by injection of dehydrated alcohol
Treatment groups
21 Participants
are divided into 3 treatment groupsGroup A: Single injection neurolysisExperimental treatment 1 intervention
Group B: Two injection neurolysisExperimental treatment 1 intervention
Group C: No injection controlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Peritumoral adrenergic nerve density on final histology
Will quantify degree of neurolysis by measuring decrease in adrenergic nerve density on radical prostatectomy specimen histology
Time frame
4 to 6 weeks after treatment initiationSecondary outcomes
1
Change in sexual health inventory for men (SHIM) score
Change in erectile function as measured by SHIM score at enrollment and 4 to 6 weeks after periprostatic neurolysis
Time frame
4 to 6 weeks after intervention2
Change in International Prostate Symptom Score (IPSS)
Change in lower urinary tract symptoms as measured by IPSS questionnaire at baseline and after neurolysis
Time frame
4 to 6 weeks after intervention3
Change in post prostatectomy penile length
Change in penile length post prostatectomy compared to baseline
Time frame
6months after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Texas Southwestern Medical Center
Lead sponsor
Urology Care Foundation
Collaborator
American Urological Association
Collaborator
Source ClinicalTrials.gov