RecruitingNot ApplicableNCT05740488

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


Sponsor

Zhujiang Hospital

Enrollment

30 participants

Start Date

Jan 7, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining apalutamide (a hormone-blocking drug for prostate cancer) with strontium-89 (a radioactive treatment that targets bone metastases) before surgery can improve outcomes for men with prostate cancer that has spread to a small number of bones (10 or fewer). **You may be eligible if...** - You have been confirmed to have prostate cancer by biopsy - Bone scans show you have 10 or fewer bone metastases - You agree to have surgery (laparoscopic radical prostatectomy plus lymph node removal) - You are willing to have hormone therapy before and after surgery - Your general health is good (ECOG score 0–1) **You may NOT be eligible if...** - You have any other tumor requiring treatment at the same time - Imaging shows cancer spread to organs other than bone (such as liver or brain), or risk of spinal cord compression - You have a history of epilepsy or conditions that may cause seizures - You have severe liver, kidney, heart, or immune system disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGApalutamide

240mg, po, qd

DRUG89Sr

100\~150MBq(based on weight), iv, q90d

DRUGLuteinizing Hormone-Releasing Hormone Analog

sc, 3.6mg, q30d or 10.8mg, q90d


Locations(1)

zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

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NCT05740488