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%

NCT ID: NCT07115992

Last Updated: 2025-08-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 270 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-30
• Study Completion Date: 2028-02-29

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

Conditions

Prostate Cancer; Prostate Adenoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental group

Participants in the experimental group will receive robot-assisted laparoscopic radical prostatectomy (RARP), followed by salvage radiotherapy only if biochemical recurrence occurs postoperatively.

Group Type: EXPERIMENTAL

RARP±SRT

Intervention Type: PROCEDURE

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.

Control group

Participants in the control group will receive RARP with extended pelvic lymph node dissection, per guideline recommendations.

Group Type: ACTIVE_COMPARATOR

RARP+ePLND

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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:

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ruijin hospital

Shanghai, , China

Site Status: RECRUITING

Countries

China

Facility Contacts

Xu

Role: primary

xdf12036@rjh.com.cn

+86-13901734568

Other Identifiers

2025-423

Identifier Type: -

Identifier Source: org_study_id