RecruitingNot ApplicableNCT05740488
Efficacy and Safety of Apalutamide in Combination With 89Sr as Neoadjuvant Therapy in Prostate Cancer With ≤10 Bone Metastases
Sponsor
Zhujiang Hospital
Enrollment
30 participants
Start Date
Jan 7, 2022
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Sex: MALEMin Age: 18 Years
Inclusion Criteria6
- 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 Criteria4
- 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
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Interventions
DRUGApalutamide
240mg, po, qd
DRUG89Sr
100\~150MBq(based on weight), iv, q90d
DRUGLuteinizing Hormone-Releasing Hormone Analog
sc, 3.6mg, q30d or 10.8mg, q90d
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05740488