CRADT: Cystoprostatectomy Versus Radiotherapy Combined With ADT for the Treatment of cT4 Prostate Cancer With Bladder Invasion
Study Details
Study Description
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 |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Overall survival (OS) [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
- Biochemical progression-free survival (BPFS) [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) [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 [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 [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 [10 years]
the complications and the incidence
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≤75, at the time of randomization
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Newly diagnosed primary prostatic adenocarcinoma confirmed by pathological examination of biopsy；diagnosed within 6 months prior to randomization
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Untreated for surgery, radiotherapy, or androgen deprivation therapy
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Eastern Cooperative Oncology Group (ECOG) performance status 0- 2; American Standards Association (ASA) classification I-III
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A life expectation of at least 10 years
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Tumor stage (T, M, N): Clinical T4N0M0 with bladder invasion (confirmed by MRI)
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Eligible for either treatment of cystoprostatectomy or radiotherapy
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Signed informed consent should be obtained from both the patient or one authorized legal relative.
Exclusion Criteria:
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Patients with a history of other cancer diagnoses except non-melanoma skin cancer
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Patients with pelvic surgery
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Patients with severe systemic diseases
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severe kidney function -glomerular filtration rate (GFR) < 30 ml/min or elevated liver transaminases above > 10 upper limit of normal (ULN)
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Patients who are not able comply with scheduled follow-up visits and examinations with the consideration of patients' physical or mental condition
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | China | 430030 |
Sponsors and Collaborators
- Tongji Hospital
- Chinese PLA General Hospital
- Xiangya Hospital of Central South University
- Hubei Cancer Hospital
Investigators
- Study Chair: Zhiqiang Chen, M.D.,Ph.D, Tongji Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CZQ5208