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New treatment option for Localized Prostate Carcinoma
Official title Feasibility and Effect of Wrapping Nerves With a Multi-Layer Perinatal Tissue Allograft During Prostatectomy
ClinicalTrials.gov ID: NCT06940271
What this study is testing
- What it's testing
- This clinical trial studies whether a new multi-layer perinatal tissue allograft, MLG-Complete (Trademark), can be used to improve complications after nerve-sparing robot-assisted radical prostatectomy (RARP) in patients with prostate cancer that has not spread to other parts of the body (localized). Two major complications that can happen after complete surgical removal of the prostate (radical prostatectomy) include erectile dysfunction and urinary incontinence, both of which greatly affect a patient's quality of life and social well-being.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 and older, men only
You may be able to join if
- Male people with age ≥ 45
- Primary diagnosis of prostate cancer selected for surgical intervention (radical prostatectomy)
- Primary diagnosis of organ confined (i.e. localized) untreated prostate cancer
- Planned elective radical prostatectomy with bilateral nerve sparing technique
- Negative urinalysis within 30 days prior to date of surgery
You likely can't join if
- High-risk cancer planned for neoadjuvant therapy, full or partial excision of neurovascular bundles
- Unable to comply with learning and documenting penile rehabilitation, including oral 5-phosphodiesterase inhibitor use, vacuum pump therapy use...
- History of \>14 days treatment with immunosuppressants (including systemic corticosteroids), cytotoxic chemotherapy within one month prior to initial...
- Prior hormonal therapy such as Lupron or oral anti-androgens
- Poor urinary control at baseline requiring the use of pads for leakage
- Previous history of pelvic radiation
See the full eligibility criteria
- Male people with age ≥ 45
- Primary diagnosis of prostate cancer selected for surgical intervention (radical prostatectomy)
- Primary diagnosis of organ confined (i.e. localized) untreated prostate cancer
- Planned elective radical prostatectomy with bilateral nerve sparing technique
- Negative urinalysis within 30 days prior to date of surgery
- Patient has no erectile dysfunction (SHIM score ≥ 19) at the time of consultation
- Willing to comply with instruction of the investigator
- Willing to comply with follow-up surveys
- Ability to provide written consent
- Negative urinary tract infection at the time of consultation
- Interest in penetrative sexual intercourse
- High-risk cancer planned for neoadjuvant therapy, full or partial excision of neurovascular bundles
- Unable to comply with learning and documenting penile rehabilitation, including oral 5-phosphodiesterase inhibitor use, vacuum pump therapy use, and/or injectable medications
- History of \>14 days treatment with immunosuppressants (including systemic corticosteroids), cytotoxic chemotherapy within one month prior to initial screening, or who receive such medications during the screening period
- Prior hormonal therapy such as Lupron or oral anti-androgens
- Poor urinary control at baseline requiring the use of pads for leakage
- Previous history of pelvic radiation
- Previous history of simple prostatectomy or transurethral prostate surgery
- Patients with obesity defined as body mass index (BMI) \> 40 kg/m\^2
- History of open pelvic surgery ≤ 5 prior to registration (except for hernia repair)
- Scheduled to undergo chemotherapy, radiation, hormone therapy, or open surgery during the study period
- Any neurologic disorder or psychiatric disorder that might confound postsurgical assessments
- Has any condition(s) which seriously compromises the subject's ability to participate in this study, sign consent, or has a known history of poor adherence with medical treatment
- In the opinion of the principal investigator (PI), has a history of drug or alcohol abuse ≤ 12 months prior to registration
- Allergic to aminoglycoside antibiotics (such as gentamicin and/or streptomycin)
- Received administration of an investigational drug within 30 days prior to registration, and/or has planned administration of another investigational product or procedure during participation in this study
The study team makes the final eligibility decision.
Where it's taking place
- Jacksonville, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 45 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jacksonville, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.