Neoadjuvant Therapy With Proxalutamide Combined With Androgen Deprivation Therapy（ADT）for High Risk Prostate Cancer
NCT ID: NCT05076851
Last Updated: 2021-10-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
2 participants
INTERVENTIONAL
2021-06-17
2022-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
placebo group
placebo+ADT
placebo
placebo+ADT（Androgen Deprivation Therapy） ，Route of placebo administration: tablet, dosage：300mg , dosage form oral , frequency of administration：QD
Proxalutamide
Proxalutamide +ADT
Proxalutamide
Proxalutamide +ADT（Androgen Deprivation Therapy） ，Route of Proxalutamide administration: tablet, dosage：300mg , dosage form oral , frequency of administration：QD
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
placebo
placebo+ADT（Androgen Deprivation Therapy） ，Route of placebo administration: tablet, dosage：300mg , dosage form oral , frequency of administration：QD
Proxalutamide
Proxalutamide +ADT（Androgen Deprivation Therapy） ，Route of Proxalutamide administration: tablet, dosage：300mg , dosage form oral , frequency of administration：QD
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
18 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hongqian Guo
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Hongqian Guo
chief physician
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hongqian Guo, Phd
Role: STUDY_CHAIR
Study Chair Department of Urology, Drum Tower Hospital, Medical School of Nanjing University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IIT-GT0918-CN-1008
Identifier Type: -
Identifier Source: org_study_id