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

Study Overview
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Brief Summary
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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.

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

Conditions
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High-Risk and Oligometastatic Prostate Cancer

Intervention / Treatment
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* Drug: Apalutamide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: high-risk and oligometastatic prostate cance<br>Neoadjuvant therapy with apalutamide in combination with luteinizing hormone-releasing hormone analogues | Drug: Apalutamide<br>* apalutamide as neoadjuvant therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rPFS | radiographic progression-free survival | Change from Baseline at preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pCR | pathological complete response | preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months. | 
| PFS | positive margin rate; progression-free survival | preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months. | 
| PSA response rate: | more than 50% decrease from baseline | preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months. | 
| TTPP | time to PSA progression | preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months. | 
| time to BCR after surgery |  | preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months. | 
| pathological stage |  | preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months. |