Status:
UNKNOWN
Cystoprostatectomy Versus Radiotherapy Combined With ADT for the Treatment of cT4 Prostate Cancer With Bladder Invasion
Lead Sponsor:
Tongji Hospital
Collaborating Sponsors:
Chinese PLA General Hospital
Xiangya Hospital of Central South University
Conditions:
Prostate Cancer
Eligibility:
MALE
18-75 years
Phase:
NA
Brief Summary
Prostate cancer is the most common male cancer in global, which accounts for 19% of the total and poses great hazards to male health. Unfavorable factors including prostatic specific antigen (PSA) \>2...
Detailed Description
1\. Determine the subjects Patients were determined in strict accordance with the inclusion and exclusion criteria, and the trial process and significance were explained to the patients, and informed...
Eligibility Criteria
Inclusion
- Age ≤75, at the time of randomization
- Newly diagnosed primary prostatic adenocarcinoma confirmed by pathological examination of biopsy；diagnosed within 6 months prior to randomization
- Untreated for surgery, radiotherapy, or androgen deprivation therapy
- Eastern Cooperative Oncology Group (ECOG) performance status 0- 2; American Standards Association (ASA) classification I-III
- A life expectation of at least 10 years
- Tumor stage (T, M, N): Clinical T4N0M0 with bladder invasion (confirmed by MRI)
- Eligible for either treatment of cystoprostatectomy or radiotherapy
- Signed informed consent should be obtained from both the patient or one authorized legal relative.
Exclusion
- Patients with a history of other cancer diagnoses except non-melanoma skin cancer
- Patients with pelvic surgery
- Patients with severe systemic diseases
- severe kidney function -glomerular filtration rate (GFR) \< 30 ml/min or elevated liver transaminases above \> 10 upper limit of normal (ULN)
- Patients who are not able comply with scheduled follow-up visits and examinations with the consideration of patients' physical or mental condition
Key Trial Info
Start Date :
June 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 12 2023
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT03482089
Start Date
June 12 2018
End Date
June 12 2023
Last Update
October 21 2022
Active Locations (1)
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1
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030