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

Intervention:

  • Procedure: Cystoprostatectomy
  • Radiation: external beam radiotherapy

Purpose: 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) >20 ng/ml, Gleason score >8, and T3/4 are significantly associated with biological recurrence, metastatic progression and poor survival in prostate cancer. In clinical T4(cT4) prostate cancer with bladder invasion patients, symptoms of hematuria, urinary urgency, bladder outlet and ureteral obstruction, and pelvic pain led to a poor quality of life. Radical prostatectomy is crucial for the multimodal treatment of prostate cancer, but limited proof demonstrated enough advantages of the surgery in T4 tumor with bladder invasion. Radical prostatectomy could hardly meet both demands of local tumor control and urinary function. Treatment trends suggest that patients with T4 prostate cancer be treated with radiotherapy combined with androgen deprivation therapy (ADT). However, surgery enables a full pathological assessment of the tumor characteristics and thus a better estimation of the risk of recurrence. Cystoprostatectomy offers an option of surgical treatment for T4 prostate cancer with bladder invasion,which can well remove the bladder and urethra, decrease the risk of positive surgical margins and avoid urination complications. There is no consensus regarding optimal treatment of T4 prostate cancer and no evidence of oncological outcomes of cystoprostatectomy from clinical trials. A randomized clinical trial comparing two multimodal treatment regimens of cystoprostatectomy and radiotherapy for T4 prostate cancer with bladder invasion is therefore warranted.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03482089

Sponsor: Tongji Hospital

Primary Outcome Measures:

  • Measure: Overall survival (OS)
  • Time Frame: 10 years
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Biochemical progression-free survival (BPFS)
  • Time Frame: 10 years
  • Safety Issue:
  • Measure: Cancer-specific survival (CSS)
  • Time Frame: 10 years
  • Safety Issue:
  • Measure: Functional Assessment of Cancer Therapy-General (FACT-G) score
  • Time Frame: 10 years
  • Safety Issue:
  • Measure: Functional Assessment of Cancer Therapy-Prostate (FACT-P) score
  • Time Frame: 10 years
  • Safety Issue:
  • Measure: complications
  • Time Frame: 10 years
  • Safety Issue:

Estimated Enrollment: 70

Study Start Date: June 12, 2018

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

Contact:

  • Zhiqiang Chen, M.D.,Ph.D
  • 008613995512271

Location:

  • Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
  • Wuhan Hubei 430030 China

View trial on ClinicalTrials.gov


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