Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07115992

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%

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostate Adenoma Prostatic Diseases Prostatic Hyperplasia Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RARP±SRT

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.

RARP+ePLND

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.

Primary outcomes

  1. 2-year Biochemical-recurrence Free Survival rate (2-year BFS)

    Time frame: 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:

    • For control group: After RARP completion.
    • For experimental group: After salvage radiotherapy completion.

Secondary outcomes

  1. PSA doubling time, PSADT

    Time frame: baseline and 2 years

  2. Radiographic progression-free survival, rPFS

    Time frame: 2 years from randomization

  3. Time to First biochemical recurrence (BCR) event in the experimental group

    Time frame: 2 years from randomization

  4. Overall survival, OS

    Time frame: 2 years from randomization

Other outcomes

  1. Operative time

    Time frame: Perioperative

  2. Incidence Rate and Severity of Radiation-related complications

    Time frame: From radiotherapy initiation through 1 month post-treatment

    • Radiation proctitis
    • Radiation cystitis Complications will be categorized per CTCAE v5.0, with Grade ≥3 defined as clinically significant.

  3. Incidence Rate and Severity of Intraoperative and 30-day postoperative complications

    Time frame: During index hospitalization (up to 30 days post-op)

    • lymphatic leakage
    • lymphocele
    • prolonged pelvic drainage (>2 weeks)
    • obturator nerve injury
    • pelvic organ injury (rectum/bladder/vasculature/ureter)
    • acute urinary retention

    Complications will be categorized per CTCAE v5.0, with Grade ≥3 defined as clinically significant.

  4. Intraoperative blood loss

    Time frame: Perioperative

  5. Hospital stay length

    Time frame: Perioperative

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study 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

Acronym: PRESEL

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Aug 11, 2025
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.