Placental tissue implant tested to speed up erection recovery after prostate removal
NCT ID NCT05366842
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether placing a special placental tissue over nerves during prostate cancer surgery helps men regain erections and bladder control faster. Only 3 men participated before the study was stopped early. The approach aimed to protect nerves during surgery, but results are too limited to draw conclusions.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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3 people
The number who actually took part.
- Started
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Apr 2022
- Finished
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Apr 2025
- Lead sponsor
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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 65 years
- Sex
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Male participants only
- Healthy volunteers
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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 Hide 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. Male sex 40 to 65 years of age with localized prostate cancer (clinical stage less than or equal to T2a, Gleason grade less than or equal to 3+4=7 (Gleason 8 or 4+3=7 will be excluded), Prostate-Specific Antigen (PSA) less than or equal to 10 ng/mL) 2. Scheduled to undergo curative radical prostatectomy applying bilateral nerve-sparing procedure 3. Intact pre-surgical erectile function (International Index of Erectile Function \[IIEF\]-5 / Sexual Health Inventory for Men (SHIM) score greater than or equal to 18) 4. Willingness to attempt intercourse at least 5 times per month following surgery. 5. Has a sexual partner of at least 6 months with current sexual activity (within the past 4 weeks) Exclusion Criteria: 1. Known penile deformity or a history of Peyronie's disease 2. Pre or postoperative androgen therapy 3. Pre or postoperative radiation therapy 4. History of high or low blood pressure that is not controlled 5. Taking nitrates medications 6. History of heart problems such as angina, heart failure, irregular heartbeats, or myocardial infarction 7. History of drug or alcohol abuse 8. Current smoker has a 20 pack/year history of cigarette smoking 9. History of acute or chronic depression 10. History of liver problems or kidney problems 11. History of retinitis pigmentosa or severe vision loss, including a condition called NAION 12. History of spinal trauma or surgery to the brain or spinal cord 13. Other contraindications to the use of phosphodiesterase inhibitor (PDE) 5 inhibitors 14. History of known sensitivities to any of the following reagents used for processing, disinfection, and storage, which may remain on the product: * Lyopreservation Solution: 18.9% w/v Trehalose in Dulbecco's Phosphate Buffered Saline * Disinfection Solution: 0.5% v/v Gentamicin Sulfate, 0.1% v/v Vancomycin reconstituted in Water for Injection (WFI), 1% v/v Amphotericin B, 98.4% Dulbecco's Modified Eagle's Medium (DMEM) * Processing Solution: DMEM, Dulbecco's Phosphate Buffered Saline (dPBS), 11% Anticoagulant Citrate Dextrose Solution in Saline, Formula A (ACD-A), 1.7% w/v Trehalose in Dulbecco's Phosphate Buffered Saline
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New PET tracer aims to light up hidden cancer targets
- Can daily adaptive radiotherapy spare healthy tissue in prostate cancer?
- Can a radioactive tracer and MRI reveal prostate Cancer's true extent?
- Five-Fraction radiation plus hormone therapy tested against High-Risk prostate cancer
- Can a 10-Hour eating window fight cancer fatigue?