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Clinical trial Recruiting at 1 site Interventional Ages 18 to 80 Men only

Comparing prostate removal with targeted salvage radiotherapy as needed versus prostate removal plus extended pelvic lymph node removal for men with intermediate/high-risk prostate cancer

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

Run by Ruijin Hospital · NCT07115992 · Data updated 2026-11-12

This trial tests whether prostate removal followed by targeted salvage radiotherapy when needed works as well and causes fewer complications than prostate removal with extended pelvic lymph node removal in men with intermediate- or high-risk localized prostate cancer and a Briganti nomogram ≥7%.

Quick facts

Study typeInterventional
Ages18 Years to 80 Years
SexMen only
Enrollment270 (estimated)
SponsorRuijin Hospital
Academic / other
Drugs / interventionschemotherapy, radiation
Locations1 site (Shanghai)
StatusRecruiting
StartedJuly 30, 2025
Main results expectedFebruary 29, 2028
Study endsFebruary 29, 2028
Registry record updatedAugust 26, 2025
Trial IDNCT07115992 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Men aged 18–80 with localized intermediate- or high-risk prostate cancer (miN0M0), a Briganti nomogram ≥7%, who are candidates for radical prostatectomy and can undergo PSMA PET/MRI are ideal candidates.

Probably not a fit

Men with prior prostate cancer treatments, non-acinar histology, imaging evidence of nodal or distant metastasis, prior pelvic lymphadenectomy or radiotherapy, or who cannot tolerate surgery or PSMA imaging are unlikely to benefit from this protocol.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Men with localized intermediate- or high-risk prostate cancer and a Briganti nomogram score of at least 7% will be treated with robot-assisted laparoscopic radical prostatectomy and either receive extended pelvic lymph node dissection at surgery or undergo prostate removal without ePLND with salvage radiotherapy given later if indicated. Eligibility requires confirmatory biopsy, PSA, and PSMA PET/MRI showing no nodal or distant metastasis. The trial compares oncologic outcomes and complication rates between the two approaches to determine if omitting ePLND plus using salvage radiotherapy can maintain cancer control while reducing harm. Safety, perioperative complications, and oncological efficacy endpoints will be collected and compared between arms.

Why it matters

Potential benefit: If successful, the approach could let some men avoid extended lymph node surgery while keeping cancer control and lowering complication rates.

How similar studies have gone: Previous studies have shown mixed results for the benefit of ePLND while salvage radiotherapy after prostatectomy is an established option, so directly testing non-inferiority of omitting ePLND in this specific Briganti ≥7% population is relatively novel.

Who can join: the full rules

Show full inclusion / 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.

Where it's running

  • Ruijin hospital
    Shanghai, China     Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.