RecruitingNot ApplicableNCT04997252
An Evaluation of the Efficacy and Safety of Apalutamide as Neoadjuvant Endocrine Therapy in High-Risk and Oligometastatic Prostate Cancer
Sponsor
Zhujiang Hospital
Enrollment
50 participants
Start Date
Feb 1, 2021
Study Type
INTERVENTIONAL
Conditions
Summary
The neoadjuvant therapy with apalutamide can significantly improve the prognosis of patients with high-risk and oligometastatic prostate cancer, lower the rate of positive margins, reduce recurrence, and show high safety.
Eligibility
Sex: MALEMin Age: 18 Years
Plain Language Summary
Simplified for easier understanding
This study tests apalutamide — a hormone-blocking drug — given before surgery (as neoadjuvant therapy) in men with high-risk or oligometastatic prostate cancer (cancer that has spread to a limited number of locations) to see if it can improve outcomes when combined with surgery and standard hormone therapy.
**You may be eligible if...**
- You are a man over 18 with confirmed prostate cancer
- Your cancer is classified as high-risk based on test results
- You are scheduled for minimally invasive radical prostatectomy (prostate removal surgery)
- You are in good physical condition (ECOG 0–1)
- You have agreed to receive both pre- and post-surgical hormone therapy
**You may NOT be eligible if...**
- You have another tumor requiring treatment
- Imaging shows spread to organs like the liver or brain, or risk of spinal cord paralysis
- You have a history of epilepsy or seizures
- You have severe liver, kidney, heart, or vascular 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
apalutamide as neoadjuvant therapy
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04997252