NCT07747272Recruiting
Nerve-SPARing Robotic Prostatectomy: The Impact of Patient Baseline Profiles on Erectile Function
Nerve-SPAREing Robotic Prostatectomy: The Impact of Patient Baseline Profiles on Erectile Function - The SPARE-EF Registry
Source: ClinicalTrials.gov · Last updated 5 Aug 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 300 (estimated)
- First submitted
- 21 Jul 2026
- Start date
- Jan 2026
- Primary completion date
- Dec 2027
- Lead sponsor
- University of Florence
- Diseases
- Prostate cancer
- NCT number
- NCT07747272
What you commit to
- Study type: Observational
- Planned participants: 300
- From Jan 2026 to the primary completion date, Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of prior pelvic radiation, cryotherapy, or extensive pelvic surgery that disrupts neurovascular anatomy.
- Neo-adjuvant androgen deprivation therapy (ADT) or chemotherapy.
Other illness
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| AOU Careggi Coordinator of this site? Confirm its status | Florence | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.