XCancer

177Lu-PSMA-617 Combined With Darolutamide in Neoadjuvant Treatment of High-risk Localized Prostate Cancer: a Prospective, Single-arm, Multi-center Clinical Trial

Description:

The goal of this clinical trial is to explore the efficacy and safety of darolutamide combined with 177Lu-PSMA-617 in treating high-risk localized prostate cancer patients who are scheduled to undergo radical prostatectomy. The main questions it aims to answer are: Does this combination treatment improve the pathological complete response rate (pCR)? What is the minimal residual disease (MRD) rate in these patients? What are the safety profiles and any adverse effects associated with this treatment? Researchers will compare the combination of darolutamide and 177Lu-PSMA-617 to a placebo to see if the combination is effective in treating high-risk localized prostate cancer. Participants will: Receive either darolutamide combined with 177Lu-PSMA-617 or a placebo every day for 12 weeks. Visit the clinic every 6 weeks for checkups and tests. Keep a diary of their symptoms and any side effects experienced during the treatment. Undergo imaging tests, including prostate MRI and PSMA PET/CT, before surgery and during follow-up.

Sponsor:

First Affiliated Hospital of Zhejiang University

Phase:

Phase 4

Contacts:

Hongqian Guo (CONTACT)

dr.ghq@nju.edu.cn

+86 (025)-83106666

Government Study Link:

NCT07677566 - Click here to see study on

ClinicalTrials.gov

PSMA-617

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules
Chelator: DOTA
Inclusion
  • Eastern Cooperative Oncology Group (ECOG) physical condition score 0- 1
  • All patients must have a histologically or cytologically diagnosis of prostate cancer，without distant metastasis, and suitable for radical prostatectomy
  • Primary lesion SUVmax ≥ 20.0 as assessed by PSMA-PET examination.
  • Adequate organ function: Complete Blood Count: White blood cell count (WBC) ≥ 3.0 × 10\^9/L, platelet count ≥ 100 × 10\^9/L, hemoglobin ≥ 9 g/dL. Renal Function: Serum creatinine ≤ 2 × ULN. Liver Function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN, total bilirubin (TBIL) ≤ 1.5 × ULN. Coagulation Function: International normalized ratio (INR) \< 1.5.
Exclusion
  • Patients who have previously received androgen deprivation therapy (medical or surgical) more than 3 months or focal treatment of prostate cancer or prostate cancer radiotherapy or prostate cancer chemotherapy
  • Primary lesion SUVmax \< 20.0 as assessed by PSMA-PET examination.
  • Patients with clinical or radiological evidence of regional or extra-regional lymph node metastases or bone metastases or visceral metastases (any M1）