Cystoprostatectomy Versus Radiotherapy Combined With ADT for the Treatment of cT4 Prostate Cancer With Bladder Invasion (CRADT)
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|ClinicalTrials.gov Identifier: NCT03482089|
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : June 21, 2018
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
(Open, laparoscopic or robot-assisted ) cystoprostatectomy with urinary diversion surgery and extended pelvic lymph node dissection; without adjuvant androgen deprivation therapy;
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
- 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.
- 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
- 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
- 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.
- 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
- complications [ Time Frame: 10 years ]the complications and the incidence
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
|Contact: Zhiqiang Chen, M.D.,Ph.Dfirstname.lastname@example.org|
|Contact: Peng Yuan, M.D.||email@example.com|
|Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology||Recruiting|
|Wuhan, Hubei, China, 430030|
|Contact: Zhiqiang Chen, M.D.,Ph.D|
|Study Chair:||Zhiqiang Chen, M.D.,Ph.D||Tongji Hospital|