Evaluating Return to Continence and Potency Following Radical Prostatectomy

Overview

About this study

The purpose of this study to evaluate the feasibility and safety of placing the MLG-Complete allograft during nerve-sparing robotic prostatectomy. Secondary objectives include the evaluation of secondary endpoints such as time to return of potency, time to return of urinary continence, as well as other subjective measures of erectile and urinary symptoms. 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Male subjects with age of at least 45
  • Primary diagnosis of prostate cancer selected for surgical intervention (Radical Prostatectomy) 
  • Primary diagnosis of organ confined 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 > 17) prior to date of surgery
  • Patient has the willingness to comply with instruction of the investigator
  • Patient has the willingness to comply with follow-up surveys
  • Have ability to provide full written consent.

Exclusion Criteria:

  • High-risk cancer planned for neoadjuvant therapy, full or partial excision of neurovascular bundles
  • Is unable to comply with learning and documenting penile rehabilitation, including oral 5-phosphodiesterase inhibitor use, vacuum pump therapy use, and/or injectable medications
  • Patients with a history of more than two weeks treatment with immuno-suppressants (including systemic corticosteroids), cytotoxic chemotherapy within one month prior to initial screening, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study
  • Patients that have had prior hormonal therapy such as Lupron or oral anti-androgens
  • Patients with 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 BMI > 40 kg/m2
  • History of open pelvic surgery within 5 years except for hernia repair
  • Scheduled at the time of screening 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 PI, has a history of drug or alcohol abuse within last 12 months
  • Is allergic to Aminoglycoside antibiotics (such as Gentamicin and/or Streptomycin)
  • Received administration of an investigational drug within 30 days prior to study, and/or has planned administration of another investigational product or procedure during participation in this study

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 2/28/2024. Questions regarding updates should be directed to the study team contact

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Ram Pathak, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available