Nerve-SPARing Robotic Prostatectomy: The Impact of Patient Baseline Profiles on Erectile Function
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18-75
SponsorUniversity of Florence
About this trial
1. STUDY PURPOSE:
Robot-assisted surgery for prostate cancer aims to remove the tumor while preserving the delicate nerves that control erections (called "nerve-sparing" surgery). Even with advanced robotics, some patients still experience erectile dysfunction after surgery. Recovery depends not only on the surgeon's technique (one-sided or two-sided nerve sparing), but also on patient unique baseline health profile. The present study aims to analyze how patient age, health history (like diabetes or high blood pressure), and pre-surgery sexual function affect recovery. Doctors will use this data to create a personalized prediction tool (a nomogram) to better advise future patients. 2. STUDY DESIGN:
This study will not change, delay, or interfere with participants' standard medical care. The surgeon will choose the safest surgical path to treat cancer. To ensure the highest quality and eliminate surgical bias, all operations will be performed by a single, highly experienced robotic surgeon who has completed over 5,000 procedures. If patients agree to join, participants will be asked to fill out private health questionnaires at four specific time points: Baseline: Before surgery. Follow-ups: At 3 months, 6 months, and 12 months after surgery. 3. STUDY MEASUREMENTS:
Erectile Function: Patient ability to achieve a functioning erection (with or without the help of medications like Viagra) at the 12-month mark compared to patient baseline.
Oncological Safety: Routine checks of patient PSA levels and surgical margins to guarantee that sparing the nerves did not compromise cancer cure
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 and ≤ 75 years at the time of screening.
Histologically confirmed, clinically localized prostate cancer (cT1-cT2, Nx/0, Mx/0).
Candidates for robot-assisted radical prostatectomy (RARP) with a planned nerve-sparing approach (unilateral or bilateral) as determined by the attending urologist.
Patient is willing and able to complete validated quality-of-life questionnaires at baseline and during follow-up.
Disqualifiers
Pre-existing severe erectile dysfunction (baseline IIEF-5 score less than or equal to 7) unrelated to prostate cancer.
History of prior pelvic radiation, cryotherapy, or extensive pelvic surgery that disrupts neurovascular anatomy.
Neo-adjuvant androgen deprivation therapy (ADT) or chemotherapy.
Severe psychiatric or cognitive illness preventing reliable self-reporting.
Trial population
Patients with proven localized prostate cancer eligible for nerve-sparing robotic prostatectomy
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
300 Participants
are grouped into 1 trial groupGroup A: Cohort 1
Trial outcomes
Primary outcomes
1
Erectile Function Recovery Rate at 12 Months using validated questionnaire (IIEF-5 score)
Defined as achieving an International Index of Erectile Function (IIEF-5) score \>17 (or a return to within \< 5 points of baseline score) at the 12-month post-operative mark, with or without the use of PDE5 inhibitors.
Time frame
12-monthsSecondary outcomes
1
Potency Maintenance Over Time using validated questionnaire (IEEF-5 score)
Changes in the mean total IIEF-5 domain scores from baseline to 3 and 6 months post-RARP
Time frame
3 and 6 months2
Oncological Safety Margins (incidence of positive surgical margins on final pathology)
The incidence of positive surgical margins (PSM) on final pathology, stratified by unilateral versus bilateral nerve-sparing cohorts.
Time frame
1 monthsSponsors and contacts
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Source ClinicalTrials.gov