High-Risk and Oligometastatic Prostate Cancer
Conditions
Brief summary
The neoadjuvant therapy with apalutamide can significantly improve the prognosis of patients with high-risk and oligometastatic prostate cancer, lower the rate of positive margins, reduce recurrence, and show high safety.
Interventions
DRUGApalutamide
apalutamide as neoadjuvant therapy
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. Adult males aged above 18 years old, no healthy volunteers included; 2. Prostate cancer confirmed by pathological findings; 3. High risk based on risk assessment, or laboratory tests suggestive of oligometastasis; 4. Agreement to undergo laparoscopic radical prostatectomy + pelvic lymphadenectomy; 5. ECOG score of 0 - 1 6. Agreement to undergo preoperative and postoperative endocrine therapy; 7. 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 |
|---|---|---|
| rPFS | Change from Baseline at preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months. | radiographic progression-free survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS | preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months. | positive margin rate; progression-free survival |
| PSA response rate: | preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months. | more than 50% decrease from baseline |
| pCR | preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months. | pathological complete response |
| time to BCR after surgery | preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months. | — |
| pathological stage | preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months. | — |
| TTPP | preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months. | time to PSA progression |
Countries
China
Contacts
Primary ContactZhang yiming
Outcome results
None listed