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Clinical trial Recruiting at 1 site Interventional Ages 40 and up Men only

Robotic surgery to remove part of the prostate while preserving the urethra for prostate cancer

Official title: Robotic Hemi-Prostatectomy With Urethral Preservation in Low and Intermediate Risk Monolateral Prostate Cancer: a Prospective Idea, Development, Exploration, Assessment and Long-term Follow-up (I.D.E.A.L.) Trial

Run by Fondazione del Piemonte per l'Oncologia · NCT05832736 · Data updated 2026-11-12

This study is testing a robotic surgery to remove part of the prostate while keeping the urethra intact to see if it helps men with low to intermediate risk prostate cancer recover better and maintain their quality of life.

Quick facts

Study typeInterventional
Ages40 Years and up
SexMen only
Enrollment36 (estimated)
SponsorFondazione del Piemonte per l'Oncologia
Academic / other
Locations1 site (Candiolo, TO)
StatusRecruiting
StartedApril 12, 2023
Main results expectedOctober 2023
Study endsOctober 2028
Registry record updatedSeptember 26, 2023
Trial IDNCT05832736 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are men with unilateral organ-confined prostate cancer, a PSA level below 20 ng/mL, and a life expectancy of at least 5 years.

Probably not a fit

Patients with advanced prostate cancer, including those with metastatic disease or significant comorbidities, may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of robotic hemi-prostatectomy with urethral preservation in patients with low to intermediate risk unilateral prostate cancer. The approach aims to achieve high disease control rates while minimizing the impact on postoperative functional outcomes such as continence and sexual function. Patients will undergo a thorough selection process based on imaging and biopsy results to ensure they meet the criteria for this minimally invasive procedure. The study will monitor surgical margins and biochemical recurrence rates to evaluate success.

Why it matters

Potential benefit: If successful, this procedure could provide a less invasive treatment option for prostate cancer patients, preserving quality of life while effectively controlling the disease.

How similar studies have gone: Other studies have shown promising results with robotic-assisted surgeries for prostate cancer, indicating that this approach may be effective.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Signature of the informed consent and consent to the use of personal data
* Prostate Specific Antigen (PSA) \< 20 ng/mL
* Unilateral organ-confined disease on MRI (performed according to ESUR recommendations and reported according to PiRads V.2) or PET-PSMA (performed according to the recommendations of the EANM and reported according to "EANM standardized reporting guidelines v1.0 for PSMA-PET")
* Histological diagnosis of acinar-type prostate cancer unilateral on target biopsy and/or standard biopsy with ISUP \< 3 and ipsilateral on imaging investigations
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
* Life expectancy ≥ 5 years
* Availability of the patient's pre-operative clinical data
* Patients must be available to carry out the follow-up visits defined by the protocol
* Absence of retroperitoneal, lymph nodal, bone or visceral metastatic lesions
* Patients eligible for robot-assisted radical prostatectomy

Exclusion Criteria:

* Special histotypes of prostate cancer
* Patients with PSA \> 20 ng/ml at diagnosis
* Impossibility to perform MRI (with pacemakers, claustrophobia…) or PET-PSMA
* Previous prostate surgery (TURP, adenomectomy)
* Concomitant treatment with other antineoplastic drugs including investigational endocrine therapies
* Serious underlying disease or uncontrolled medical condition including active and uncontrolled infections
* Patients with dementia or psychiatric illness that limit compliance with study requirements or that could prevent understanding and/or signing the informed consent.

Where it's running

  • Fondazione del Piemonte per l'Oncologia
    Candiolo, To, Italy     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.