Robotic Hemi-Prostatectomy With Urethral Preservation in Low and Intermediate Risk Monolateral Prostate Cancer

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age40+
SponsorFondazione del Piemonte per l'Oncologia

About this trial

On the basis of the now consolidated literature and clinical experience of focal therapies, the execution of partial prostatectomy/hemiprostatectomy with robot-assisted laparoscopic technique can be proposed in a well-selected cohort of patients.

The hypothesis is that with this technique it is possible to achieve excellent levels of disease control, in terms of positive surgical margins (PSM) and biochemical recurrence of the disease (BCR), against a minimal impact as regards postoperative functional outcomes (continence and sexual power).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • Robotic hemi-prostatectomy with urethral preservation

    Procedure/Surgery

    Robotic hemi-prostatectomy with urethral preservation

Treatment groups

36 Participants
are divided into 1 treatment group
Group A: Patients with unilateral prostate cancerExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility of the robotic hemiprostatectomy technique

Evaluate the feasibility of the robotic hemiprostatectomy technique in both a preclinical and clinical setting as ratio between the number of hemiprostatectomies completed and the total number of prostatectomies performed

Time frame
Baseline

Secondary outcomes

1

Safety of the robotic hemiprostatectomy technique

Evaluate the safety of the robotic hemiprostatectomy technique in terms of intra and post-operative complications using the Clavien-Dindo classification. The Clavien-Dindo classification evaluates severity of complications in 5 groups: * Grade I: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions; * Grade II: Requiring pharmacological treatment with drugs other than such allowed for grade I complications; * Grade III: Requiring surgical, endoscopic or radiological intervention (IIIa: Intervention not under general anesthesia; IIIb: Intervention under general anesthesia); * Grade IV Life-threatening complication requiring IC/ICU-management (IVa: single organ dysfunction; IVb: multiorgan dysfunction); * Grade V: Death of a patient.

Time frame
30 days
2

Positive Surgical Margins (PSMs) rate

Evaluate the oncological efficacy in terms of Positive Surgical Margins (PSMs) at the final histological examination as rate between cases with Positive Surgical Margins over the total of the specimens analyzed by pathologists.

Time frame
30 days
3

Biochemical Recurrence (BCR) rate

Evaluate the oncological efficacy in terms of Biochemical Recurrence (BCR) during the follow-up period as rate between patients with BCR over the total of patients in the study group. The BCR is any rise in the blood level of PSA (prostate-specific antigen) in prostate cancer patients after treatment with surgery or radiation.

Time frame
5 years
4

Urinary continence after surgery

Evaluate the functional outcomes in terms of urinary continence during the follow-up period. The urinary continence will be assessed by the net weight of urine collected in the pad over 24 hours (Pad test). This outcome will be shown by the mont after the surgery in which the patient reach the complete continence defined as no urine loss at the Pad test.

Time frame
5 years

Other outcomes

Sponsors and contacts

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