Clinical Trial · NCT05740488

Efficacy and Safety of Apalutamide in Combination With 89Sr as Neoadjuvant Therapy in Prostate Cancer With ≤10 Bone Metastases

Overview

The aim of this study is to evaluate the efficacy and safety of apalutamide in combination with 89Sr as neoadjuvant therapy in prostate cancer with ≤10 bone metastases. The primary endpoint is PFS and the second endpoints are pCR, rPFS, PSA response, pain score, number and extent of bone metastases.

Sponsor

Xijing Hospital

Phase

N/A

Contacts

Zhang Yiming (CONTACT)

359281481@qq.com

020-62782726

Chen Binshen (STUDY_CHAIR)

ClinicalTrials.gov

NCT05740488

Drug / Compound

strontium chloride

Isotope(s):

Target(s):

Bone Metabolism

Ligand Class: Small Molecules

Eligibility

Inclusion

Agreement to undergo preoperative and postoperative endocrine therapy and 89Sr radionuclide therapy;
Bone metastasis confirmed by bone scan, the number of bone metastases ≤10
Prostate cancer confirmed by pathological findings;
Agreement to undergo laparoscopic radical prostatectomy + pelvic lymphadenectomy;
ECOG score of 0 - 1

Exclusion

Any other tumor disease requiring treatment;
Severe liver or kidney dysfunction, severe cardiovascular or cerebrovascular diseases, and systemic immune system diseases
Any organ metastasis confirmed by imaging, such as liver and brain metastases, or the possibility of paralysis due to spinal cord metastasis;
A history of epilepsy or any condition that may lead to seizures;