Nerve-SPARing Robotic Prostatectomy: The Impact of Patient Baseline Profiles on Erectile Function

Recruiting now

Conditions studied: Prostate Cancer, Prostatectomy, Robotic Surgery, Erectile Function

In brief

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

Key facts

Study ID

NCT07747272

Run by

University of Florence

People needed

300

Starts

2026-01-01

Expected to finish

2028-03-30

Last updated by the study team

2026-08-05

Who can join

Age: 18 and older, up to 75. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Signed informed consent prior to enrollment.

You may not qualify if…

• 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.

Where it is running

• AOU Careggi — Florence, Italy, Italy (enrolling)

Full record on ClinicalTrials.gov

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