Comparing two surgical approaches for localized prostate cancer with a high lymph node risk
Compares prostate removal with or without later radiotherapy against removal with lymph node removal.
Plain-language title generated from the registry record
Registry 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%
Key facts
- Where
- Shanghai, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07115992, who can take part
Where in China
- Ruijin hospitalShanghai, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ruijin Hospital
- Trial code
- NCT07115992
- Record updated
- 26 August 2025
- Original description
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:Read full original descriptionShow less
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
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
Inclusion: Provided signed and dated informed consent form; Be male aged 18-80 years at consent; Commit to protocol compliance and complete all study procedures; Medically fit to tolerate interventions, including PSMA PET imaging, RARP, pelvic radiotherapy; Diagnosis of localized intermediate/high-risk prostate cancer (miN0M0):; Confirmed by: systematic biopsy + PSA + PSMA PET/MRI. ii. Briganti nomogram (2017)≥7%. iii. Candidate for radical prostatectomy. iv. D'Amico:; Intermediate-risk: PSA 10-20ng/mL OR Gleason 7 (ISUP Grade 2/3) OR cT2b; High-risk: PSA>20ng/mL OR Gleason>7 (ISUP Grade 4/5) OR cT2c.
Exclusion: Prior treatments for prostate cancer, including radiotherapy, chemotherapy or endocrine therapy; Contraindications to radiotherapy or intolerance determined by radiation oncologists; Preoperative evidence of metastasis: nodal(N1), locally advanced(T3-4), or distant(M1) disease on imaging; History of pelvic lymphadenectomy or radiotherapy; Other malignancies within 5 years; Severe allergy to PSMA PET ligands or excipients; Any other conditions precluding PSMA PET examination; Non-acinar adenocarcinoma histology on biopsy; Contraindications to radical prostatectomy or being deemed surgically inoperable upon clinical assessment.