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

NCT07747272 | Recruiting

• 1 other identifier: CareggiPrN14-2026
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.STUDY PURPOSE:
2. 2.STUDY DESIGN:
3. 3.STUDY MEASUREMENTS:

Conditions

Prostate Cancer; Prostatectomy; Erectile Function; Robotic Surgery

Keywords

prostate cancer; robotic surgery; prostatectomy; nerve-sparing; erectile function

Outcome Measures

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.

  12-months

Secondary Outcomes (2)

• Potency Maintenance Over Time using validated questionnaire (IEEF-5 score)

  3 and 6 months

• Oncological Safety Margins (incidence of positive surgical margins on final pathology)

  1 months

Study Arms (1)

Cohort 1

One single cohort of patients submitted to nerve sparing (mono- or bilateral) robotic prostatectomy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with proven localized prostate cancer eligible for nerve-sparing robotic prostatectomy

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.

Sponsors & Collaborators

• University of Florence: lead

Study Sites (1)

AOU Careggi

Florence, Italy, 50141, Italy

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Antonio Andrea Grosso AAG MD, PhD

CONTACT

+39 3920978948; antonioandrea.grosso@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: August 5, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): March 30, 2028
• Last Updated: August 5, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Access Criteria: Documents will be available upon request to the contact person

Locations

IT (1)