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NCT Number: NCT05832736

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

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).

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

40 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione del Piemonte per l'Oncologia

Candiolo, TO, 10060, Italy

Location status: Recruiting

Location contact

Enrico Checcucci

CONTACT

[email protected]

+39 011 9933921

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Robotic hemi-prostatectomy with urethral preservation

Procedure

Robotic hemi-prostatectomy with urethral preservation

Other names: Partial prostatectomy

Primary outcomes

  1. Feasibility of the robotic hemiprostatectomy technique

    Time frame: Baseline

    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

Secondary outcomes

  1. Safety of the robotic hemiprostatectomy technique

    Time frame: 30 days

    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.

  2. Positive Surgical Margins (PSMs) rate

    Time frame: 30 days

    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.

  3. Biochemical Recurrence (BCR) rate

    Time frame: 5 years

    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.

  4. Urinary continence after surgery

    Time frame: 5 years

    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.

  5. Potency recovery after surgery

    Time frame: 5 years

    Evaluate the functional outcomes in terms of potency recovery during the follow-up period.

    The potency recovery will be assessed by the International Index of Erectile Function - 5 (IIEF-5) test. This test will be collected every follow-up visit and results will be shown as progression of the IIEF-5 during the 5 years after the surgery.

    The IIEF-5 contains 5 items and uses the sum scores and cutoff points to categorize the severity of the erectile dysfunction. This scale ranges from 5 points (severe erectile dysfunction) to 25 points (no erectile dysfunction).

Study contacts

Contact information is provided by the study sponsor or research team.

Francesco Porpiglia

CONTACT

[email protected]

+39 011 9933921

Sponsors and collaborators

Lead sponsor

Fondazione del Piemonte per l'Oncologia

Other

Registry information

Official study 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

Acronym: RETURN

Important dates

Study start
2023
Primary completion
2023
Study completion
2028
First posted
Apr 27, 2023
Registry last updated
Sep 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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