An Evaluation of the Efficacy and Safety of Apalutamide as Neoadjuvant Endocrine Therapy in High-Risk and Oligometastatic Prostate Cancer

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhujiang Hospital

Criteria

Inclusion Criteria:

1. Adult males aged above 18 years old, no healthy volunteers included;

2. Prostate cancer confirmed by pathological findings;

3. High risk based on risk assessment, or laboratory tests suggestive of oligometastasis;

4. Agreement to undergo laparoscopic radical prostatectomy + pelvic lymphadenectomy;

5. ECOG score of 0 - 1

6. Agreement to undergo preoperative and postoperative endocrine therapy;

7. Voluntary signing of an ICF for the clinical trial

Exclusion Criteria:

1. Any other tumor disease requiring treatment;

2. Any organ metastasis confirmed by imaging, such as liver and brain metastases, or the possibility of paralysis due to spinal cord metastasis;

3. A history of epilepsy or any condition that may lead to seizures;

4. Severe liver or kidney dysfunction, severe cardiovascular or cerebrovascular diseases, and systemic immune system diseases.