Efficacy and Safety of Apalutamide in Combination With 89Sr as Neoadjuvant Therapy in Prostate Cancer With ≤10 Bone Metastases
NCT ID: NCT05740488
Last Updated: 2024-03-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2022-01-07
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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apalutamide combined with 89Sr and ADT
Neoadjuvant therapy with apalutamide in combination with 89Sr and ADT
Apalutamide
240mg, po, qd
89Sr
100\~150MBq(based on weight), iv, q90d
Luteinizing Hormone-Releasing Hormone Analog
sc, 3.6mg, q30d or 10.8mg, q90d
Interventions
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Apalutamide
240mg, po, qd
89Sr
100\~150MBq(based on weight), iv, q90d
Luteinizing Hormone-Releasing Hormone Analog
sc, 3.6mg, q30d or 10.8mg, q90d
Eligibility Criteria
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Inclusion Criteria
2. Bone metastasis confirmed by bone scan, the number of bone metastases ≤10
3. Agreement to undergo laparoscopic radical prostatectomy + pelvic lymphadenectomy;
4. ECOG score of 0 - 1
5. Agreement to undergo preoperative and postoperative endocrine therapy and 89Sr radionuclide therapy;
6. Voluntary signing of an ICF for the clinical trial
Exclusion Criteria
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
18 Years
MALE
No
Sponsors
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Zhujiang Hospital
OTHER
Responsible Party
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Binshen Chen
associate chief physician
Principal Investigators
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Chen Binshen
Role: STUDY_CHAIR
Southern Medical University, China
Locations
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zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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yiming zhang
Role: primary
Other Identifiers
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2022-KY-241-02
Identifier Type: -
Identifier Source: org_study_id
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