Nerve-Sparing Robotic Prostatectomy: How Baseline Health Affects Post-Surgery Erections
Official title: Nerve-SPAREing Robotic Prostatectomy: The Impact of Patient Baseline Profiles on Erectile Function - The SPARE-EF Registry
Run by University of Florence · NCT07747272 · Data updated 2026-11-12
Researchers will test whether a patient’s age, health history, and pre-surgery sexual function can predict erectile function after nerve-sparing robot-assisted prostatectomy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | Men only |
| Enrollment | 300 (estimated) |
| Sponsor | University of Florence Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Florence, Italy) |
| Status | Recruiting |
| Started | January 1, 2026 |
| Main results expected | December 31, 2027 |
| Study ends | March 30, 2028 |
| Registry record updated | August 5, 2026 |
| Trial ID | NCT07747272 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18-75 with localized prostate cancer planned for robot-assisted radical prostatectomy with nerve-sparing.
✕Probably not a fit
Patients with pre-existing severe erectile dysfunction unrelated to prostate cancer or those not planning to undergo nerve-sparing surgery may derive little or no benefit from the prediction tool.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study analyzes how baseline patient factors such as age, metabolic conditions, and initial sexual function influence recovery of erectile function after robot-assisted radical prostatectomy with nerve-sparing techniques. All surgeries are performed by an experienced surgeon using a consistent robotic approach to minimize bias. Data from baseline questionnaires and follow-up assessments will be used to build a nomogram to help counsel future patients on their individual risk of erectile dysfunction after surgery.
Why it matters
Potential benefit: If successful, the study could provide a personalized prediction tool to better guide patients and clinicians in preoperative counseling and shared decision-making.
How similar studies have gone: Prior research supports the idea that baseline factors influence erectile function after prostatectomy, but this study aims to personalize predictions with a nomogram.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥ 18 and ≤ 75 years at the time of screening. 2. Histologically confirmed, clinically localized prostate cancer (cT1-cT2, Nx/0, Mx/0). 3. Candidates for robot-assisted radical prostatectomy (RARP) with a planned nerve-sparing approach (unilateral or bilateral) as determined by the attending urologist. 4. Patient is willing and able to complete validated quality-of-life questionnaires at baseline and during follow-up. 5. Signed informed consent prior to enrollment. Exclusion Criteria: 1. Pre-existing severe erectile dysfunction (baseline IIEF-5 score less than or equal to 7) unrelated to prostate cancer. 2. History of prior pelvic radiation, cryotherapy, or extensive pelvic surgery that disrupts neurovascular anatomy. 3. Neo-adjuvant androgen deprivation therapy (ADT) or chemotherapy. 4. Severe psychiatric or cognitive illness preventing reliable self-reporting.
Where it's running
-
AOU Careggi
Florence, Italy, Italy Recruiting
Study contacts
- Study coordinator: Antonio Andrea Grosso AAG MD, PhD
- Email: antonioandrea.grosso@gmail.com
- Phone: +39 3920978948
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
High Dose Rate Brachytherapy for Prostate Cancer Recurrence
This study is testing if a special type of radiation treatment called High Dose Rate Brachytherapy can help men with prostate cancer that has come back after surgery feel better and have fewer side effects compared to regular radiation.
-
Treatment for male overactive bladder using sacral neuromodulation
This study is testing a new device to see if it can help men with overactive bladder feel better after prostate surgery or radiation therapy.
-
Personalized treatment for prostate cancer to improve quality of life after surgery
This study is testing whether a personalized treatment using apalutamide can help improve the quality of life and reduce fatigue for prostate cancer patients with detectable PSA levels after surgery, compared to standard therapy.
-
Pain management plan implementation for major open abdominal surgeries
This trial tests an opioid-epidural pain management approach to see if it improves post-surgical pain control for adults undergoing open abdominal procedures like colectomy, hepatectomy, and nephrectomy.
-
Targeted alpha therapy for B7-H3 expressing solid tumors using AKY-2519
This phase 1b trial tests a radiolabeled drug (AKY-2519) to see if it's safe and tolerable in adults with B7-H3 positive advanced solid tumors, including NSCLC and SCLC, with imaging to help guide use.
-
PSMA-guided surgery and tissue-resident T cells in node-positive prostate cancer
This study tests whether PSMA-guided surgery can help identify and study tissue-resident T cells in prostate cancer that has spread to lymph nodes.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.