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The aim of this study is to evaluate the efficacy and safety of apalutamide in combination with 89Sr as neoadjuvant therapy in prostate cancer with ≤10 bone metastases. The primary endpoint is PFS and the second endpoints are pCR, rPFS, PSA response, pain score, number and extent of bone metastases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| apalutamide combined with 89Sr and ADT | Experimental | Neoadjuvant therapy with apalutamide in combination with 89Sr and ADT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apalutamide | Drug | 240mg, po, qd |
| |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | progression-free survival | Up to 2 years after radical prostatectomy |
| Measure | Description | Time Frame |
|---|---|---|
| pCR | pathological complete response | Up to 1 year |
| rPFS | radiographic progression-free survival | Up to 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhang Yiming | Contact | 020-62782726 | 359281481@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Chen Binshen | Southern Medical University, China | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| zhujiang Hospital of Southern Medical University | Recruiting | Guangzhou | Guangdong | 510200 | China |
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| 89Sr |
| Drug |
100~150MBq(based on weight), iv, q90d |
|
| Luteinizing Hormone-Releasing Hormone Analog | Drug | sc, 3.6mg, q30d or 10.8mg, q90d |
|
| PSA response rate | more than 50% decrease from baseline | Up to 3 years |
| pain score | Measurement of pain assessed by a Visual Analogue Scale (VAS). The analogous visual scale used for this study measures from 0 to 10 the intensity of pain with a series of "faces" that show the intensity in the pain experimentation with categories such as "No pain" in number 0, mild in number 1-3, moderate in number 4-6, intense in number 7-9 and worst in number 10. | Measured at baseline and follow up visits throughout the study, an average of 3 years |
| number and extent of bone metastases | Bone Scan | Up to 3 years |
| ID | Term |
|---|---|
| C572045 | apalutamide |
| D007987 | Gonadotropin-Releasing Hormone |
| ID | Term |
|---|---|
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
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