Prostate Cancer With ≤10 Bone Metastases
Conditions
Brief 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.
Interventions
DRUGApalutamide
240mg, po, qd
DRUG89Sr
100\ 150MBq(based on weight), iv, q90d
sc, 3.6mg, q30d or 10.8mg, q90d
Sponsors
Zhujiang Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | Up to 2 years after radical prostatectomy | progression-free survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pCR | Up to 1 year | pathological complete response |
| rPFS | Up to 3 years | radiographic progression-free survival |
| PSA response rate | Up to 3 years | more than 50% decrease from baseline |
| pain score | Measured at baseline and follow up visits throughout the study, an average of 3 years | 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. |
| number and extent of bone metastases | Up to 3 years | Bone Scan |
Countries
China
Contacts
Primary ContactZhang Yiming
Outcome results
None listed