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Could a placental wrap help men recover erections faster after prostate cancer surgery?

NCT ID NCT05842057

Disease control Sponsor: University of Miami Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time

Summary

This trial tests whether placing a dehydrated human amnion chorion membrane (dHACM) over the nerves during robot-assisted prostate removal helps men recover erectile function and urinary control sooner. The study enrolls men aged 40 to 80 with localized prostate cancer who have good erectile function before surgery. The membrane is a placental tissue allograft placed over the nerves on each side of the prostate.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a dehydrated human amnion chorion membrane (dHACM) placed over nerves during prostate surgery
What this could lead to
If it works, this could offer a way to speed up recovery of erectile function and urinary control after prostate cancer surgery.
What could go wrong
This is a mid-stage trial with 118 men, so results are not yet proven. The membrane may not improve recovery, and there are risks from surgery itself.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

118 people

The number who actually took part.

Started

Aug 2023

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 80 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1\. Men aged 40 to 80 years with localized prostate cancer who are undergoing RARP at the University of Miami (UM). Exclusion Criteria: 1. Men requiring the use of any non-oral erectile aids for erectile dysfunction (ED). 2. Men with baseline EPIC26 scores \< 50. 3. Patients with complete, bilateral nerve resection. 4. Previous treatment for prostate cancer. 5. Previous history of pelvic radiation. 6. Patients with impaired decision-making capacity.

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Conditions

The condition(s) this trial relates to.

erectile dysfunction prostate cancer prostate carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Erectile dysfunction following radical prostatectomy Prostate cancer

Contacts and locations

Locations

  • University of Miami

    Miami, Florida, 33136, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.