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Cystoprostatectomy Versus Radiotherapy Combined With ADT for the Treatment of cT4 Prostate Cancer With Bladder Invasion (CRADT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03482089
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : June 21, 2018
Sponsor:
Collaborators:
Chinese PLA General Hospital
Xiangya Hospital of Central South University
Hubei Cancer Hospital
Information provided by (Responsible Party):
Tongji Hospital

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) >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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Procedure: Cystoprostatectomy Radiation: external beam radiotherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : June 12, 2018
Estimated Primary Completion Date : June 12, 2023
Estimated Study Completion Date : June 12, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Cystoprostatectomy
(Open, laparoscopic or robot-assisted ) cystoprostatectomy with urinary diversion surgery and extended pelvic lymph node dissection; without adjuvant androgen deprivation therapy;
Procedure: Cystoprostatectomy
Patients with bladder infiltrating T4 prostate cancer receive cystoprostatectomy with urinary diversion surgery and extended pelvic lymph node dissection

Active Comparator: Radiotherapy
Radiotherapy by external beam radiotherapy (81 Gy,2.4-4 Gy per fraction over 4-6 weeks); with adjuvant androgen deprivation therapy for the least 3 years
Radiation: external beam radiotherapy
Patients with bladder infiltrating T4 prostate cancer are treated with adjuvant androgen deprivation therapy




Primary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: 10 years ]
    The percentage of subjects in a study who have survived at the the endpoint of the observation since randomization or the interval between randomization and death from any cause.


Secondary Outcome Measures :
  1. Biochemical progression-free survival (BPFS) [ Time Frame: 10 years ]
    the interval between randomization and biochemical recurrence or death from any cause or the percentage of subjects in a study who have survived without biochemical recurrence at the endpoint of the observation since randomization

  2. Cancer-specific survival (CSS) [ Time Frame: 10 years ]
    the interval between randomization and tumor recurrence, metastasis, or death from any cause, or the percentage of subjects in a study who have survived without tumor recurrence or metastasis at the endpoint of the observation since randomization

  3. Functional Assessment of Cancer Therapy-General (FACT-G) score [ Time Frame: 10 years ]
    This is a score system assessing cancer patients' quality of life, including four aspects of physical status, social status, emotional status and functional status. The total score ranges from 0-108 and a higher score indicates a better outcome.

  4. Functional Assessment of Cancer Therapy-Prostate (FACT-P) score [ Time Frame: 10 years ]
    This is a score system assessing prostate cancer patients' quality of life. The total score ranges from 0-48 and a higher score indicates a better outcome

  5. complications [ Time Frame: 10 years ]
    the complications and the incidence



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03482089


Contacts
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Contact: Zhiqiang Chen, M.D.,Ph.D 008613995512271 zhqchen8366@163.com
Contact: Peng Yuan, M.D. 008615927679790 mwyuanpeng@163.com

Locations
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China, Hubei
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology Recruiting
Wuhan, Hubei, China, 430030
Contact: Zhiqiang Chen, M.D.,Ph.D         
Sponsors and Collaborators
Tongji Hospital
Chinese PLA General Hospital
Xiangya Hospital of Central South University
Hubei Cancer Hospital
Investigators
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Study Chair: Zhiqiang Chen, M.D.,Ph.D Tongji Hospital

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Responsible Party: Tongji Hospital
ClinicalTrials.gov Identifier: NCT03482089    
Other Study ID Numbers: CZQ5208
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: June 21, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs