Recruiting

Ultrasound

Sponsor:

Mayo Clinic

Code:

NCT05109208

Conditions

Prostate Adenocarcinoma

Eligibility Criteria

Sex: Male

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Ulrasound Vibroelastography (UVE)

Study Details

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.

Conditions

Prostate Adenocarcinoma

Study ID

NCT05109208

Start date

Oct 2, 2023

Status verified date

Jun, 2026

Completion date

Oct 31, 2028

Anticipated

Primary completion date

Oct 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 40+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Ultrasound viscoelastography (UVE) in radical proctectomy recovery

Subjects undergoing radical prostatectomy for prostate cancer disease as standard of care will have a ultrasound vibroelastography performed before surgery, 3 months, 6 months and 9 months post-prostatectomy.

Interventions

Ulrasound Vibroelastography (UVE)

Ultrasound technique to quantitatively assess tissue stiffness (elasticity and viscosity) by applying vibration through a specialized probe (indenter).

Primary outcome measure

  • Change in Viscoelasticity [ Time Frame: Baseline, 3 months, 6 months and 9 months post-prostatectomy ]

Central Contacts and Locations

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Wyatt Anians

507-538-6151Anians.Wyatt@mayo.edu

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Matt J. Ziegelmann, M.D.

More Information

Sponsor

Mayo Clinic

Last update posted

Jun 9, 2026

Last verified

Jun, 2026

Keywords

  • Radical Prostatectomy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-06-09.