An Evaluation of the Efficacy and Safety of Apalutamide as Neoadjuvant Endocrine Therapy in High-Risk and Oligometastatic Prostate Cancer
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
China
zhujiang Hospital of Southern Medical University
RECRUITING
Guangzhou
Contact Information
Primary
Zhang yiming
59281481@qq.com
020-62782726
Time Frame
Start Date: 2021-02-01
Estimated Completion Date: 2024-12
Participants
Target number of participants: 50
Treatments
Experimental: high-risk and oligometastatic prostate cance
Neoadjuvant therapy with apalutamide in combination with luteinizing hormone-releasing hormone analogues
Related Therapeutic Areas
Sponsors
Leads: Zhujiang Hospital