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% (PRESEL)

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Prostate Adenoma; Prostate Cancer

Treatments: Procedure: RARP+ePLND; Procedure: RARP±SRT

Study type: Interventional

Funder types: Other

Identifiers

NCT07115992

2025-423

Details and patient eligibility

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

Enrollment: 270 estimated patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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270 participants in 2 patient groups

Experimental group

Experimental group

Description:

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

Treatment:

Procedure: RARP±SRT

Control group

Active Comparator group

Description:

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

Treatment:

Procedure: RARP+ePLND