Neoadjuvant Therapy \High Risk Prostate Cancer
Conditions
Brief summary
This trial aims to evaluate the efficacy and safety of neoadjuvant therapy with Proxalutamide combined with androgen deprivation therapy（ADT）for High risk prostate cancer ，This trial is A randomized, controlled, double-blind, single center.Treatment cycle is 6 months,
Interventions
OTHERplacebo
placebo+ADT（Androgen Deprivation Therapy） ，Route of placebo administration: tablet, dosage：300mg , dosage form oral , frequency of administration：QD
DRUGProxalutamide
Proxalutamide +ADT（Androgen Deprivation Therapy） ，Route of Proxalutamide administration: tablet, dosage：300mg , dosage form oral , frequency of administration：QD
Sponsors
Hongqian Guo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Proxalutamide: androgen deprivation therapy（ADT）=2:1
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients must participate voluntarily and sign an informed consent form (ICF), indicating that they understand the purpose and required procedures of the study 2. Patients must be ≥ 18，male 3. Histopathological by Prostate biopsy confirmed prostatic cancer（No Neuroendocrine prostate cancer or small cell carcinoma） 4. High-risk prostate cancer (T2c≤ clinical stage ≤T4 or Gleason score ≥8 or PSA≥20ng/ml) 5. Patients willing to undergo laparoscopic radical resection of prostate cancer and extensive lymph node dissection 6. ECOG PS：0-1
Exclusion criteria
1. Imaging or biopsy confirmed distant Metastatic lesion 2. The number of regional lymph nodes metastasis \>3 3. Patients had undergone The treatment of Systemic chemotherapy and endocrine therapy for prostate cancer 4. Patients had undergone prostate surgery、radical radiotherapy or Bilateral orchidectomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathologic Complete Response Rate | up to 6months | The proportion of subjects with no morphologically recognizable cancer cell in tumor specimens after radical prostatectomy |
| Proportion of Subjects With Minimal Residual Disease | up to 6months | The proportion of subjects that have residual tumors with maximum diameter of 3 mm or less after radical prostatectomy |
Countries
China
Contacts
Primary ContactHongqian Guo, Phd
Backup ContactShun Zhang, Phd
Outcome results
None listed