Erectile Function After Nerve-Sparing Robotic Surgery for Prostate Cancer
Follows men after robotic prostate cancer surgery to see how health affects erections.
Key facts
- Who runs it
- University of Florence
- Where
- Florence, ItalySee the site
- Trial code
- Registry title
- Nerve-SPARing Robotic Prostatectomy: The Impact of Patient Baseline Profiles on Erectile Function
- Status
- Recruiting
- People taking part
- 300 people, planned
- Started
- 1 Jan 2026
- Expected to end
- 30 Mar 2028
- Type of study
- Observational
- Record updated
- 5 August 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men aged 18 to 75 with localized prostate cancer who will have robot-assisted prostate removal with nerve-sparing surgery. It tracks erectile function for 12 months.
- Age
- 18 to 75 years
- Sex
- Men only
- Disease stage
- Prostate cancer confirmed by tissue test, localized (cT1-cT2, Nx/0, Mx/0)
- Earlier treatment
- Cannot have had pelvic radiation, cryotherapy, extensive pelvic surgery, androgen deprivation therapy (ADT) before surgery, or chemotherapy before surgery.
Main reasons for not taking part
- Severe erectile problems before cancer (IIEF-5 score of 7 or less)
- Earlier pelvic radiation, cryotherapy or extensive pelvic surgery
- Hormone therapy (ADT) or chemotherapy before surgery
- Severe psychiatric or cognitive illness that prevents reliable self-reporting
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- 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
Who cannot take part
- History of prior pelvic radiation, cryotherapy, or extensive pelvic surgery that disrupts neurovascular anatomy
- Neo-adjuvant androgen deprivation therapy (ADT) or chemotherapy
- Pre-existing severe erectile dysfunction (baseline IIEF-5 score less than or equal to 7) unrelated to prostate cancer
- Severe psychiatric or cognitive illness preventing reliable self-reporting
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Where in Italy
- AOU CareggiFlorence, ItalyContact: Antonio Andrea Grosso AAG MD, PhDTaking people
About the trial
What the trial wants to find out
1. STUDY PURPOSE:
Read full original descriptionShow less
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
The group in the trial
- Cohort 1
One single cohort of patients submitted to nerve sparing (mono- or bilateral) robotic prostatectomy
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Nerve-SPAREing Robotic Prostatectomy: The Impact of Patient Baseline Profiles on Erectile Function - The SPARE-EF Registry
- Plain-language title
- Erectile Function After Nerve-Sparing Robotic Surgery for Prostate CancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07747272, who can take part
- Record updated
- 5 August 2026