Actively Recruiting
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%
Led by Ruijin Hospital · Updated on 2025-08-26
270
Participants Needed
1
Research Sites
134 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
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%
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided signed and dated informed consent form.
- Male aged 18 to 80 years at consent.
- Willing to follow the study protocol and complete all study procedures.
- Medically able to undergo PSMA PET imaging, robot-assisted laparoscopic radical prostatectomy, and pelvic radiotherapy.
- Diagnosed with localized intermediate- or high-risk prostate cancer (miN0M0) confirmed by systematic biopsy, PSA, and PSMA PET/MRI.
- Briganti nomogram score of 7% or higher.
- Candidate for radical prostatectomy.
- Intermediate-risk defined by PSA 10-20 ng/mL or Gleason 7 (ISUP Grade 2/3) or clinical stage T2b.
- High-risk defined by PSA greater than 20 ng/mL or Gleason greater than 7 (ISUP Grade 4/5) or clinical stage T2c.
You will not qualify if you...
- Prior treatments for prostate cancer such as radiotherapy, chemotherapy, or endocrine therapy.
- Biopsy showing non-acinar adenocarcinoma histology.
- Evidence of metastasis before surgery, including nodal (N1), locally advanced (T3-4), or distant (M1) disease on imaging.
- History of pelvic lymphadenectomy or pelvic radiotherapy.
- Other cancers diagnosed within the past 5 years.
- Any contraindications to radical prostatectomy or surgical inoperability.
- Any contraindications to radiotherapy or intolerance as assessed by radiation oncologists.
- Severe allergy to PSMA PET ligands or their components.
- Any other conditions that prevent PSMA PET examination.
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Trial Site Locations
Total: 1 location
1
Ruijin hospital
Shanghai, China, 221000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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