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:

  1. Age ≤75, at the time of randomization
  2. Newly diagnosed primary prostatic adenocarcinoma confirmed by pathological examination of biopsy;diagnosed within 6 months prior to randomization
  3. Untreated for surgery, radiotherapy, or androgen deprivation therapy
  4. Eastern Cooperative Oncology Group (ECOG) performance status 0- 2; American Standards Association (ASA) classification I-III
  5. A life expectation of at least 10 years
  6. Tumor stage (T, M, N): Clinical T4N0M0 with bladder invasion (confirmed by MRI)
  7. Eligible for either treatment of cystoprostatectomy or radiotherapy
  8. Signed informed consent should be obtained from both the patient or one authorized legal relative.

Exclusion Criteria:

  1. Patients with a history of other cancer diagnoses except non-melanoma skin cancer
  2. Patients with pelvic surgery
  3. Patients with severe systemic diseases
  4. severe kidney function -glomerular filtration rate (GFR) < 30 ml/min or elevated liver transaminases above > 10 upper limit of normal (ULN)
  5. 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


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