Prostate AdenocarcinomaNCT05109208
The Use of Ultrasound in Assessing Post-prostatectomy Erectile Dysfunction
A study testing Ulrasound Vibroelastography (UVE) in people with Prostate Adenocarcinoma, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Prostate Adenocarcinoma
- What is being tested?
- Ulrasound Vibroelastography (UVE)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2023to 31 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Wyatt Anians, 507-538-6151, Anians.Wyatt@mayo.edu
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
About this study
Official title: Ultrasound Vibroelastography in Post-Prostatectomy Erectile Dysfunction
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
- Being tested
- Ulrasound Vibroelastography (UVE)
- Keywords
- Radical Prostatectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ulrasound Vibroelastography (UVE)Diagnostic test
Ultrasound technique to quantitatively assess tissue stiffness (elasticity and viscosity) by applying vibration through a specialized probe (indenter).
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound viscoelastography (UVE) in radical proctectomy recovery | Experimental | 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. Receives: Diagnostic Test: Ulrasound Vibroelastography (UVE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Viscoelasticity
As measured by Ultrasound Vibroelastography (UVE)
Measured: Baseline, 3 months, 6 months and 9 months post-prostatectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start2 Oct 2023
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew J. Ziegelmann, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05109208
- Sponsor's protocol ID
- 21-001713
- Status last verified
- Jun 2026
- First submitted
- 26 Oct 2021
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Vibroelastography in Post-Prostatectomy Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT05109208
- Acronym / sponsor ID
- 21-001713
- Conditions
- Prostate Adenocarcinoma
- Keywords
- Radical Prostatectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 5 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasound viscoelastography (UVE) in radical proctectomy recovery | Experimental | Diagnostic Test: Ulrasound Vibroelastography (UVE)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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ulrasound Vibroelastography (UVE)Ultrasound technique to quantitatively assess tissue stiffness (elasticity and viscosity) by applying vibration through a specialized probe (indenter). | Diagnostic test | Ultrasound viscoelastography (UVE) in radical proctectomy recovery |
Primary outcome
Change in Viscoelasticity
Time frame: Baseline, 3 months, 6 months and 9 months post-prostatectomy
As measured by Ultrasound Vibroelastography (UVE)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthew J. Ziegelmann, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ulrasound Vibroelastography (UVE) in people with Prostate Adenocarcinoma, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Viscoelasticity (time frame: Baseline, 3 months, 6 months and 9 months post-prostatectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.