Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT03482089 |
Other study ID # |
CZQ5208 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
June 12, 2018 |
Est. completion date |
June 12, 2023 |
Study information
Verified date |
October 2022 |
Source |
Tongji Hospital |
Contact |
Zhiqiang Chen, M.D.,Ph.D |
Phone |
008613995512271 |
Email |
zhqchen8366[@]163.com |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
Description:
1. Determine the subjects
Patients were determined in strict accordance with the inclusion and exclusion criteria, and
the trial process and significance were explained to the patients, and informed consent was
signed.
2 Randomization
The patients were randomly assigned to surgery group or radiotherapy group according to the
random number table.
3 Implementation Process
The intervention measures were divided into operation group and non-operation group. The
operation group was given cystoprostatectomy + expanded pelvic lymph node dissection +
urinary diversion. The non-operation group received radiotherapy plus androgen deprivation
therapy.
4 Follow-up Process
Follow-up was performed once a month (12 times in total) in the first year after surgery or
radiotherapy, once every 3 months (4 times in total) in the second year, and once every six
months after 2 years. Follow-up items included the presence of complications, digital rectal
examination, PSA and testosterone levels, liver and kidney function. If digital rectal
examination is positive and serum PSA continues to rise, pelvic MRI and bone scan should be
performed. Bone pain, regardless of PSA level, should be scanned.
FunctionalAssessment of Cancer Therapy-General (FACT-G; FunctionalAssessment of Cancer
Therapy-Prostate, FACT-P) and color Doppler ultrasonography of bilateral kidney and ureter
were performed once every six months after 1 year.
Pelvic MRI, bone scan, chest radiograph, and color ultrasound of abdomen (liver, bile,
pancreas and spleen) were examined once a year after surgery or radiotherapy.
Other follow-up examination items or follow-up time can be selected according to special
circumstances. The patients were followed up for at least 10 years after surgery or after the
end of radiotherapy.
5. Monitoring and management of recurrence, metastasis and complications
If biochemical recurrence after surgery (PSA level two consecutive acuity 0.2 ng/ml, two test
interval of 2 weeks) or local recurrence, choose save radiotherapy, 8 Gy single, range is the
whole pelvic, continued progress or control again after recurrence after radiotherapy are
endocrine therapy, and its solution for than carew amine (50 mg 1 time, 1 times a day,
Orally) + Goserelin (3.6mg once every 28 days, subcutaneously injected into the anterior
abdominal wall); Patients with extensive metastasis after surgery were treated directly with
endocrine therapy (bicalutamide 50mg once daily, orally) plus gosererin (3.6mg once every 28
days, subcutaneously injected into the anterior abdominal wall). The remaining tumor
progression was managed according to the recommendations of authoritative guidelines at home
and abroad.
The time of occurrence, name of complication, patient status, Clavien-Dindo complication
classification, treatment measures and procedures, and treatment results were recorded.
Complications were managed according to the recommendations of the guidelines and the
experience of our unit.