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
Inclusion Criteria7
- Adult males aged above 18 years old, no healthy volunteers included;
- Prostate cancer confirmed by pathological findings;
- High risk based on risk assessment, or laboratory tests suggestive of oligometastasis;
- Agreement to undergo laparoscopic radical prostatectomy + pelvic lymphadenectomy;
- ECOG score of 0 - 1
- Agreement to undergo preoperative and postoperative endocrine therapy;
- Voluntary signing of an ICF for the clinical trial
Exclusion Criteria4
- Any other tumor disease requiring treatment;
- 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;
- Severe liver or kidney dysfunction, severe cardiovascular or cerebrovascular diseases, and systemic immune system diseases.
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Interventions
DRUGApalutamide
apalutamide as neoadjuvant therapy
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04997252