NCT07115992Recruiting
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%
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
Source: ClinicalTrials.gov · Last updated 26 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 270 (estimated)
- First submitted
- 24 Jul 2025
- Start date
- 30 Jul 2025
- Primary completion date
- 29 Feb 2028
- Lead sponsor
- Ruijin Hospital
- Diseases
- Prostate cancer
- NCT number
- NCT07115992
What you commit to
- Study type: Interventional
- Planned participants: 270
- From 30 Jul 2025 to the primary completion date, 29 Feb 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatments for prostate cancer, including radiotherapy, chemotherapy or endocrine therapy.
- Contraindications to radiotherapy or intolerance determined by radiation oncologists.
Other illness
- 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.
- Severe allergy to PSMA PET ligands or excipients.
- Any other conditions precluding PSMA PET examination.
Other
- Non-acinar adenocarcinoma histology on biopsy.
- Contraindications to radical prostatectomy or being deemed surgically inoperable upon clinical assessment.
Who the study is looking for
- 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):
- 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.
Age in the registry: 18 years to 80 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ruijin hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.