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Trial Title:
Efficacy and Safety of Apalutamide in Combination With 89Sr as Neoadjuvant Therapy in Prostate Cancer With ≤10 Bone Metastases
NCT ID:
NCT05740488
Condition:
Prostate Cancer With ≤10 Bone Metastases
Conditions: Official terms:
Prostatic Neoplasms
Neoplasm Metastasis
Bone Neoplasms
Bone Marrow Diseases
Hormones
Prolactin Release-Inhibiting Factors
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Apalutamide
Description:
240mg, po, qd
Arm group label:
apalutamide combined with 89Sr and ADT
Intervention type:
Drug
Intervention name:
89Sr
Description:
100~150MBq(based on weight), iv, q90d
Arm group label:
apalutamide combined with 89Sr and ADT
Intervention type:
Drug
Intervention name:
Luteinizing Hormone-Releasing Hormone Analog
Description:
sc, 3.6mg, q30d or 10.8mg, q90d
Arm group label:
apalutamide combined with 89Sr and ADT
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Prostate cancer confirmed by pathological findings;
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:
1. Any other tumor disease requiring treatment;
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
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
zhujiang Hospital of Southern Medical University
Address:
City:
Guangzhou
Zip:
510200
Country:
China
Status:
Recruiting
Contact:
Last name:
yiming zhang
Start date:
January 7, 2022
Completion date:
December 2025
Lead sponsor:
Agency:
Zhujiang Hospital
Agency class:
Other
Source:
Zhujiang Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05740488
