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%

Launched by RUIJIN HOSPITAL · Aug 4, 2025

Keywords

ClinConnect Summary

This clinical trial is studying two different approaches to surgery for men with intermediate- or high-risk localized prostate cancer, which means the cancer is still confined to the prostate area but has a higher chance of growing or spreading. The researchers want to find out if having just the prostate surgery (called radical prostatectomy) followed by additional radiation treatment only if needed later is as effective and safer than doing the prostate surgery along with removing nearby lymph nodes (called extended pelvic lymph node dissection) right away. They will compare cancer control and side effects between these two approaches.

Men who are 18 to 80 years old with confirmed localized prostate cancer that meets specific risk criteria and who are healthy enough for surgery and imaging tests may be eligible to join. Participants will have one of the two types of surgeries: either prostate removal alone with radiation added later only if the cancer seems to come back, or prostate removal combined with lymph node removal. After surgery, participants will have regular blood tests to check their PSA levels—a marker used to monitor prostate cancer—every 1 to 3 months for two years, plus yearly imaging scans to watch for any signs of cancer returning. They will also be asked to report any side effects or complications promptly. This study aims to help doctors understand which treatment offers the best balance of effectiveness and safety for men facing this type of prostate cancer.

Gender

MALE

Eligibility 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.