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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| high-risk and oligometastatic prostate cance | Experimental | Neoadjuvant therapy with apalutamide in combination with luteinizing hormone-releasing hormone analogues |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apalutamide | Drug | apalutamide as neoadjuvant therapy |
|
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhang yiming | Contact | 020-62782726 | 59281481@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| zhujiang Hospital of Southern Medical University | Recruiting | Guangzhou | Guangdong | 510200 | China |
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| ID | Term |
|---|---|
| C572045 | apalutamide |
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| 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. |