Partial Prostatectomy for Prostate Cancer

NCT ID: NCT06624813

Last Updated: 2024-10-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2025-12-31

Brief Summary

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).

Detailed Description

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Partial prostatectomy

Robot-assisted partial prostatectomy in patients with prostate cancer

Group Type: EXPERIMENTAL

Robot-assisted partial prostatectomy

Intervention Type: PROCEDURE

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

Interventions

Robot-assisted partial prostatectomy

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

Intervention Type: PROCEDURE

Other Intervention Names

Robot-assisted partial prostatectomy in patients with prostate cancer

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Instituto do Cancer do Estado de São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Insituto do Câncer do Estado de São Paulo

São Paulo, , Brazil

Site Status: RECRUITING

Countries

Brazil

Facility Contacts

Rafael Coelho, MD-PhD

Role: primary

coelhouro@yahoo.com.br

+55(11) 3893-2000

Rafael Coelho, MD-PhD

Role: backup

Other Identifiers

BRAZILIAN MINISTRY OF HEALTH

Identifier Type: OTHER

Identifier Source: secondary_id

ICESP (CCEP ICESP 4017/23)

Identifier Type: -

Identifier Source: org_study_id