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%

Not Applicable

Not yet recruiting

• Conditions: Prostate Cancer; Prostate Adenoma

• Registration Number: NCT07115992
• Lead Sponsor: Ruijin Hospital

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-24
• Study Start: 2025-08-01
• Study First Submitted QC: 2025-08-04
• Last Update Submitted: 2025-08-04
• Study First Posted: 2025-08-11
• Last Update Posted: 2025-08-11
• Primary Completion: 2028-02-29
• Study Completion: 2028-02-29

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 270

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:

  1. Intermediate-risk: PSA 10-20ng/mL OR Gleason 7 (ISUP Grade 2/3) OR cT2b;
  2. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
2-year Biochemical-recurrence Free Survival rate (2-year BFS)	2 years from randomization	The 2-year biochemical recurrence-free survival rate (2-year BFS) will be recorded from randomization. Biochemical recurrence (BCR) is defined as serum PSA≥0.2ng/mL confirmed by at least one repeat test \>6 weeks postoperatively. Time to first BCR event is measured: 1. For control group: After RARP completion.; 2. For experimental group: After salvage radiotherapy completion.

Secondary Outcome Measures

Name	Time	Method
PSA doubling time, PSADT	baseline and 2 years
Radiographic progression-free survival, rPFS	2 years from randomization
Time to First biochemical recurrence (BCR) event in the experimental group	2 years from randomization
Overall survival, OS	2 years from randomization

Trial Locations

Locations (1)

Ruijin hospital; 🇨🇳 Shanghai, China