Prostate Adenocarcinoma
Conditions
Keywords
Radical Prostatectomy
Brief summary
Researchers are trying to determine whether there is additional utility to using vibroelastography, a noninvasive ultrasound technique to evaluate for the presence of tissue fibrosis, in conjunction with standard penile duplex Doppler ultrasound to assess erectile function (recovery) after prostate cancer surgery.
Interventions
DIAGNOSTIC_TESTUlrasound Vibroelastography (UVE)
Ultrasound technique to quantitatively assess tissue stiffness (elasticity and viscosity) by applying vibration through a specialized probe (indenter).
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
include: * Age \> 40 years * Clinically localized prostate cancer (American Urological Association Grade Groups 1-2; cT1c or cT2a-b; PSA \< 10) without clinic or imaging evidence of localized extra-prostatic or metastatic disease (i.e. AUA low and favorable intermediate risk prostate cancer) * International Index of Erectile Function (IIEF) of ≥ 21 points at baseline (no or mild erectile dysfunction) * Patient-expressed interest in consultation for sexual function (erectile function) preservation/ optimization * Planned bilateral nerves-paring prostatectomy
Exclusion criteria
include: * Moderate or severe ED based in IIEF criteria (score \< 21) * History of prior pelvic or penile surgery * Current or prior androgen deprivation therapy * Planned non-nerve sparing prostatectomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Viscoelasticity | Baseline, 3 months, 6 months and 9 months post-prostatectomy | As measured by Ultrasound Vibroelastography (UVE) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMatthew J. Ziegelmann, M.D.
Mayo Clinic
Outcome results
None listed