Cystoprostatectomy Versus Radiotherapy Combined With Androgen Deprivation Therapy for the Treatment of Clinical T4 Prostate Cancer With Bladder Invasion: a Multicentre, Prospective, Open, Randomized Clinical Trial
Condition: Prostate Cancer
Study Type: Interventional
Clinical Trials Identifier NCT 8-digits: NCT03482089
Sponsor: Tongji Hospital
Eligibility:
- Age: minimum 18 Years maximum 75 Years
- Gender: Male
Inclusion Criteria:
- 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 Criteria:
- 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
View trial on ClinicalTrials.gov