Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2025-12-26 @ 10:22 AM
Study NCT ID:
NCT07115992
Status:
RECRUITING
Last Update Posted:
2025-08-26
First Post:
2025-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Radical Prostatectomy (RP) With or Without Salvage Radiotherapy Versus RP With Extended Pelvic Lymph Node Dissection for Localized Intermediate- and High-risk Prostate Cancer With a Briganti Nomogram≥7%
Sponsor:
Ruijin Hospital
Organization:
Study Overview
Official Title:
Efficacy and Safety of Radical Prostatectomy (RP) With or Without Salvage Radiotherapy Versus RP With Extended Pelvic Lymph Node Dissection for Localized Intermediate- and High-risk Prostate Cancer With a Briganti Nomogram≥7%: an Open-label, Single-center, Non-inferiority Randomized Controlled Study
Status:
RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRESEL
Brief Summary:
The goal of this clinical trial is to evaluate efficacy and safety of radical prostatectomy (RP) with or without salvage radiotherapy versus RP with extended pelvic lymph node dissection (ePLND) in males who have localized intermediate/high-risk prostate cancer with a Briganti nomogram no less than 7%. The main questions this study aim to answer are:
1. Is RP with or without salvage radiotherapy non-inferior to RP with ePLND in efficacy for patients with localized intermediate/high-risk prostate cancer with a Briganti nomogram no less than 7%?
2. Will complication rates of RP with or without salvage radiotherapy be significantly lower than those of RP with ePLND?
Researchers will compare the experimental arm (robot-assisted laparoscopic radical prostatectomy with or without salvage radiotherapy) versus the control arm (robot-assisted laparoscopic radical prostatectomy with ePLND) to see if differences exist in oncological efficacy and safety outcomes.
Participants will:
1. Undergo one of the following surgical interventions:
1. Robot-assisted laparoscopic radical prostatectomy (RARP) with extended pelvic lymph node dissection (ePLND), OR
2. RARP alone, followed by salvage radiotherapy only if biochemical recurrence occurs postoperatively
2. Complete scheduled monitoring activities:
1. Serum PSA testing: Monthly or every 3 months within 2 years after surgery
2. PSMA PET/CT scans: Annually until study completion
3. Report all treatment-related complications within 24 hours of onset
1. Is RP with or without salvage radiotherapy non-inferior to RP with ePLND in efficacy for patients with localized intermediate/high-risk prostate cancer with a Briganti nomogram no less than 7%?
2. Will complication rates of RP with or without salvage radiotherapy be significantly lower than those of RP with ePLND?
Researchers will compare the experimental arm (robot-assisted laparoscopic radical prostatectomy with or without salvage radiotherapy) versus the control arm (robot-assisted laparoscopic radical prostatectomy with ePLND) to see if differences exist in oncological efficacy and safety outcomes.
Participants will:
1. Undergo one of the following surgical interventions:
1. Robot-assisted laparoscopic radical prostatectomy (RARP) with extended pelvic lymph node dissection (ePLND), OR
2. RARP alone, followed by salvage radiotherapy only if biochemical recurrence occurs postoperatively
2. Complete scheduled monitoring activities:
1. Serum PSA testing: Monthly or every 3 months within 2 years after surgery
2. PSMA PET/CT scans: Annually until study completion
3. Report all treatment-related complications within 24 hours of onset
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: