Efficacy and Safety of Apalutamide in Combination With 89Sr as Neoadjuvant Therapy in Prostate Cancer With ≤10 Bone Metastases

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy and Safety of Apalutamide in Combination With 89Sr as Neoadjuvant Therapy in Prostate Cancer With ≤10 Bone Metastases

Conditions
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Prostate Cancer With ≤10 Bone Metastases

Intervention / Treatment
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* Drug: Apalutamide
* Drug: 89Sr
* Drug: Luteinizing Hormone-Releasing Hormone Analog


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Prostate cancer confirmed by pathological findings; Bone metastasis confirmed by bone scan, the number of bone metastases ≤10 Agreement to undergo laparoscopic radical prostatectomy + pelvic lymphadenectomy; ECOG score of 0 - 1 Agreement to undergo preoperative and postoperative endocrine therapy and 89Sr radionuclide 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: apalutamide combined with 89Sr and ADT<br>Neoadjuvant therapy with apalutamide in combination with 89Sr and ADT | Drug: Apalutamide<br>* 240mg, po, qd<br>Drug: 89Sr<br>* 100 150MBq(based on weight), iv, q90d<br>Drug: Luteinizing Hormone-Releasing Hormone Analog<br>* sc, 3.6mg, q30d or 10.8mg, q90d<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | progression-free survival | Up to 2 years after radical prostatectomy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pCR | pathological complete response | Up to 1 year | 
| rPFS | radiographic progression-free survival | Up to 3 years | 
| 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 |