Robotic surgery to remove part of the prostate while preserving the urethra for prostate cancer
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 40 Years and up |
| Sex | Male |
| Sponsor | Fondazione del Piemonte per l'Oncologia Academic / other |
| Locations | 1 site (Candiolo, TO) |
| Trial ID | NCT05832736 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with advanced prostate cancer, including those with metastatic disease or significant comorbidities, may not benefit from this study.
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 performed: Other studies have shown promising results with robotic-assisted surgeries for prostate cancer, indicating that this approach may be effective.
Eligibility criteria
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 this trial is running
Candiolo, TO
- Fondazione del Piemonte per l'Oncologia — Candiolo, To, Italy (Recruiting)
Study contacts
- Principal investigator: Francesco Porpiglia — Fondazione del Piemonte per l'Oncologia
- Study coordinator: Francesco Porpiglia
- Email: francesco.porpiglia@unito.it
- Phone: +39 011 9933921
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.