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%
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: RARP±SRT, RARP+ePLND.
- Who it may be relevant to
- Registry conditions: Prostate Cancer, Prostate Adenoma. Basic parameters: 18 years — 80 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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
Interventions
- Procedure RARP±SRT
Participants will undergo robot-assisted radical prostatectomy (RARP). Upon biochemical recurrence, they will receive salvage radiotherapy: 52.5-62.5 Gy in 20-25 fractions/2.5-3.0 Gy per fraction, per 2025 AUA/ASTRO/SUO guidelines. - Procedure RARP+ePLND
Participants will undergo robot-assisted radical prostatectomy (RARP) with extended pelvic lymph node dissection (ePLND), encompassing bilateral removal of obturator, external iliac, internal iliac, and common iliac lymph nodes. The dissection field extends laterally to the genitofemoral nerve, medially to the bladder wall, proximally to the ureter crossing the common iliac vessels, and distally to the deep circumflex iliac vein and femoral canal.
Primary outcome measures
- 2-year Biochemical-recurrence Free Survival rate (2-year BFS) [Time frame: 2 years from randomization]
Secondary outcome measures (4)
- PSA doubling time, PSADT [Time frame: baseline and 2 years]
- Radiographic progression-free survival, rPFS [Time frame: 2 years from randomization]
- Time to First biochemical recurrence (BCR) event in the experimental group [Time frame: 2 years from randomization]
- Overall survival, OS [Time frame: 2 years from randomization]
Eligibility criteria
Inclusion criteria
- 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):
i. 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 criteria
- Prior treatments for prostate cancer, including radiotherapy, chemotherapy or endocrine therapy.
- Non-acinar adenocarcinoma histology on biopsy.
- 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.
- Contraindications to radical prostatectomy or being deemed surgically inoperable upon clinical assessment.
- Contraindications to radiotherapy or intolerance determined by radiation oncologists.
- Severe allergy to PSMA PET ligands or excipients.
- Any other conditions precluding PSMA PET examination.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Ruijin hospital — Shanghai
Identifiers
NCT: NCT07115992 · 2025-423