Partial Prostatectomy for Prostate Cancer

Instituto do Cancer do Estado de São Paulo50 enrolled

Overview

A phase 2 study investigation of safety and feasibility of partial prostatectomy for localized prostate cancer of intermediate risk at ICESP. It will be included 50 patients that have coincident findings of prostate cancer site on prostate biopsy and a suspicious area in the magnetic resonance imaging of the prostate (PIRADS 3, 4 or 5).

This Phase 2 study aims to evaluate the feasibility and standardization of robotic partial prostatectomy in patients with localized intermediate-risk prostate cancer. The study will enroll 50 patients who have undergone prostate biopsies, categorized as Gleason grade group 2 or 3, with image-guided fusion at the Cancer Institute of the State of São Paulo. Eligible patients must also have a multiparametric prostate MRI (mpMRI) with a PIRADS score of 3 to 5, consistent with the biopsy laterality. Surgeries will be performed at the Cancer Institute of the State of São Paulo by a high-volume robotic surgeon (Rafael Ferreira Coelho) using the da Vinci surgical system. Patients involved in this research will receive follow-up care in a specialized outpatient clinic, where multidisciplinary teams will administer questionnaires assessing urinary function, sexual function, perioperative pain, and quality of life, both preoperatively and postoperatively. Data will be collected in person and stored on the online REDCap® platform. Postoperative complications will be classified and assessed using the Clavien-Dindo scale during the first 90 days following surgery. Oncological follow-up will include quarterly PSA tests in the first year, every four months in the second year, and semi-annually from the third year onward, continuing until the end of the five-year follow-up period. A new mpMRI and protocol biopsy of the remaining prostate lobe will be performed at the 6th and 12th month of follow-up, respectively. Patients with negative biopsies for residual neoplasia will continue to be monitored with PSA. If residual neoplasia is detected, complementary treatment will be administered based on a shared decision-making process between the physician and the patient. This study will be conducted in compliance with Resolution 466/2012 of the National Health Council/Ministry of Health (CNS/MS) and the Declaration of Helsinki (2000), following approval from the Research Ethics Committee on Human Beings (CEPSH). The study anticipates that patients treated under this protocol will achieve satisfactory oncological outcomes, with minimal impact on functional aspects such as urinary incontinence or sexual dysfunction, and low rates of postoperative complications or negative effects on quality of life.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostate Cancer

Interventions

Robot-assisted partial prostatectomyPROCEDURE

Focal therapy with surgery for single lobe prostate cancer, partial robot-assisted partial prostatectomy

Eligibility

Sex: MALEMin age: 40 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: Patients with prostate cancer that presents an institutional (ICESP) fusion biopsy (cognitive or target) that presents 1. Fusion-guided prostate biopsy with mpMRI performed at the São Paulo State Cancer Institute, which 2. Present fragments for ISUP group grade (GG) ≤ 3 in only one of the prostate lobes 3. Multiparametric prostate resonance with PIRADS 3 - 5 and which is in agreement with the laterality of the tumor in the prostate biopsy 4. Life expectancy ≥ 10 years according to the Charlson score 5. Absence of second primary cancer under active treatment. Patients treated for cancer from other sites for more than 5 years and without evidence of disease will be allowed 6. Able to read, understand and complete the informed consent related to the research, as well as the research questionnaires on quality of life and functional parameters on erection and urinary continence Exclusion Criteria: 1. Patients with prostate cancer with an histology different from adenocarcinoma 2. Suspicion of lymph node metastasis on mpMRI or distant bone scintigraphy 3. definitive signs of extraprostatic extension on mpMRI 4. history of pelvic/prostatic radiotherapy 5. ISUP grade group ≥ 4 6. Laterality of prostate biopsy discordant with mpMRI findings

Locations (1)

Insituto do Câncer do Estado de São Paulo

São Paulo, Brazil

RECRUITING

Outcomes

Primary Outcomes

Five-year postoperative retreatment-free survival

Rate of patients who are free from additional treatment for the reminiscent prostatic lobe

Time frame: 5 years

Secondary Outcomes

Sexual Health Inventory for Men (SHIM)

\- Each question is scored from 1 to 5, with the total score ranging from 5 to 25. Higher scores indicate better erectile function.

Time frame: 3rd, 6th, 12th, 18th and 24th months

American Urological Association Symptom Index - International Prostate Symptom Score (AUA-IPSS)

\- Each symptom question is scored from 0 to 5, with the total symptom score ranging from 0 to 35. Higher scores indicate more Lower Urinary Tract Symptoms;

Time frame: 3rd, 6th, 12th, 18th and 24th months

Expanded Prostate Cancer Index Composite

\- EPIC is a comprehensive questionnaire designed to assess the health-related quality of life in men undergoing treatment for prostate cancer. EPIC evaluates a broad range of symptoms and concerns that men may experience before, during, and after treatment. It provides a detailed assessment of urinary, bowel, sexual, and hormonal domains, each of which is scored and can be transformed to a scale of 0 to 100. Higher scores indicate better health-related quality of life or fewer symptoms.

Time frame: 3rd, 6th, 12th, 18th and 24th months

Quality of life: EuroQol-5D

EuroQol, often referred to as EQ-5D, is a standardized instrument developed by the EuroQol Group to measure health-related quality of life. EQ-5D: The responses to the five dimensions can be combined into a single index value representing the health status. The resulting index value reflects the health-related quality of life on a scale from less than 0 to 1, where 1 represents perfect health, 0 represents a health state equivalent to being dead, and negative values represent health states perceived as worse than being dead.

Data from ClinicalTrials.gov

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