Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06624813
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-04-19
Brief Title:
Partial Prostatectomy for Prostate Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Partial Robot-assisted Laparoscopic Prostatectomy for Intermediate Risk Prostate Cancer
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
P-RALP
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 4662012 of the National Health CouncilMinistry of Health CNSMS 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
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 4662012 of the National Health CouncilMinistry of Health CNSMS 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None