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
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 270 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Male |
| Sponsor | Ruijin Hospital Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT07115992 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Shanghai
- Ruijin hospital — Shanghai, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.