Actively Recruiting
Radiotherapy or Surgery Combined With Intense Androgen Deprivation Therapy for mCRPC
Led by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Updated on 2025-05-28
144
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
Sponsors
T
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Lead Sponsor
T
The First Affiliated Hospital of Soochow University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This multi-center randomized controlled phase II trial was carried out in several hospitals in China to evaluate the efficacy and safety of radiotherapy or radical prostatectomy combined with intense androgen deprivation therapy for newly diagnosed metastatic prostate cancer.
CONDITIONS
Official Title
Radiotherapy or Surgery Combined With Intense Androgen Deprivation Therapy for mCRPC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed prostate adenocarcinoma with distant metastasis diagnosed by PSMA PET/CT or PSMA PET/MR, involving 10 or fewer metastatic sites without visceral metastasis
- Primary lesion is resectable or can become resectable after intense androgen deprivation therapy
- Testosterone level above castration range or castration level for no more than 3 months
- Eastern Cooperative Oncology Group (ECOG) physical condition score of 0 or 1
- Adequate blood, liver, and kidney function
- Voluntary participation with signed informed consent
- Fertile patients agree to use effective contraception during the study
You will not qualify if you...
- Prostate cancer tissue showing neuroendocrine, small cell, or sarcomatoid features
- Primary lesion assessed as unresectable
- Prior androgen deprivation therapy exceeding 3 months or prior focal therapy, radiotherapy, or chemotherapy for prostate cancer
- Severe or uncontrolled underlying diseases preventing surgery or radiotherapy
- New York Heart Association (NYHA) Class III/IV heart failure, unstable angina, or recent myocardial infarction within 6 months
- Uncontrolled severe hypertension, uncontrolled diabetes, oxygen-dependent lung disease, chronic liver disease, or HIV infection
- Other malignant tumors within 5 years except cured basal or squamous cell skin cancer
- Mental illness, mental disability, or inability to give informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University
Nanjing, Jiangsu, China, 210008
Actively Recruiting
Research Team
J
Junlong Zhuang, PhD
CONTACT
H
Hongqian Guo, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here