Prostate CancerCRADTNCT03482089
Cystoprostatectomy Versus Radiotherapy Combined With ADT for the Treatment of cT4 Prostate Cancer With Bladder Invasion
A study testing Cystoprostatectomy and external beam radiotherapy in people with Prostate Cancer, run by Tongji Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Cystoprostatectomy and external beam radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 12 Jun 2018to 12 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≤75, at the time of randomization
- Newly diagnosed primary prostatic adenocarcinoma confirmed by pathological examination of biopsy；diagnosed within 6 months prior to randomization
- Untreated for surgery, radiotherapy, or androgen deprivation therapy
- Eastern Cooperative Oncology Group (ECOG) performance status 0- 2; American Standards Association (ASA) classification I-III
- A life expectation of at least 10 years
- Tumor stage (T, M, N): Clinical T4N0M0 with bladder invasion (confirmed by MRI)
- Eligible for either treatment of cystoprostatectomy or radiotherapy
- Signed informed consent should be obtained from both the patient or one authorized legal relative.
Who cannot join
- Patients with a history of other cancer diagnoses except non-melanoma skin cancer
- Patients with pelvic surgery
- Patients with severe systemic diseases
- severe kidney function -glomerular filtration rate (GFR) < 30 ml/min or elevated liver transaminases above > 10 upper limit of normal (ULN)
- Patients who are not able comply with scheduled follow-up visits and examinations with the consideration of patients' physical or mental condition
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Zhiqiang Chen, M.D.,Ph.D
About this study
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
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.
Read the detailed description
- 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.
- 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.
- Conditions
- Prostate Cancer
- Being tested
- Cystoprostatectomy, external beam radiotherapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CystoprostatectomyProcedure or surgery
Patients with bladder infiltrating T4 prostate cancer receive cystoprostatectomy with urinary diversion surgery and extended pelvic lymph node dissection
external beam radiotherapyRadiation
Patients with bladder infiltrating T4 prostate cancer are treated with adjuvant androgen deprivation therapy
| Study group | Role | What they receive |
|---|---|---|
| Cystoprostatectomy | Experimental | (Open, laparoscopic or robot-assisted ) cystoprostatectomy with urinary diversion surgery and extended pelvic lymph node dissection; without adjuvant androgen deprivation therapy; Receives: Procedure: Cystoprostatectomy |
| Radiotherapy | Active comparator | 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 Receives: Radiation: external beam radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
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.
Measured: 10 years
Secondary outcomes (5)
Biochemical progression-free survival (BPFS)
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
Measured: 10 years
Cancer-specific survival (CSS)
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
Measured: 10 years
Functional Assessment of Cancer Therapy-General (FACT-G) score
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.
Measured: 10 years
Functional Assessment of Cancer Therapy-Prostate (FACT-P) score
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
Measured: 10 years
complications
the complications and the incidence
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start12 Jun 2018
- Primary completion12 Jun 2023 (estimated)
- Study completion12 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese PLA General Hospital, Xiangya Hospital of Central South University, Hubei Cancer Hospital
- Responsible party
- Sponsor
- Investigators
- Zhiqiang Chen, M.D.,Ph.D, Study chair, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03482089
- Sponsor's protocol ID
- CZQ5208
- Acronym
- CRADT
- Status last verified
- Oct 2022
- First submitted
- 18 Mar 2018
- Last updated
- 21 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03482089
- Acronym / sponsor ID
- CRADT / CZQ5208
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Collaborators
- Chinese PLA General Hospital, Xiangya Hospital of Central South University, Hubei Cancer Hospital
- Study start
- 12 Jun 2018 (actual)
- Primary completion
- 12 Jun 2023 (estimated)
- Study completion
- 12 Jun 2023 (estimated)
- First posted
- 29 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cystoprostatectomy | Experimental | Procedure: Cystoprostatectomy(Open, laparoscopic or robot-assisted ) cystoprostatectomy with urinary diversion surgery and extended pelvic lymph node dissection; without adjuvant androgen deprivation therapy; |
| Radiotherapy | Active comparator | Radiation: external beam radiotherapyRadiotherapy 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≤75, at the time of randomization
- Newly diagnosed primary prostatic adenocarcinoma confirmed by pathological examination of biopsy；diagnosed within 6 months prior to randomization
- Untreated for surgery, radiotherapy, or androgen deprivation therapy
- Eastern Cooperative Oncology Group (ECOG) performance status 0- 2; American Standards Association (ASA) classification I-III
- A life expectation of at least 10 years
Key exclusion criteria (5 listed)
- Patients with a history of other cancer diagnoses except non-melanoma skin cancer
- Patients with pelvic surgery
- Patients with severe systemic diseases
- severe kidney function -glomerular filtration rate (GFR) < 30 ml/min or elevated liver transaminases above > 10 upper limit of normal (ULN)
- Patients who are not able comply with scheduled follow-up visits and examinations with the consideration of patients' physical or mental condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CystoprostatectomyPatients with bladder infiltrating T4 prostate cancer receive cystoprostatectomy with urinary diversion surgery and extended pelvic lymph node dissection | Procedure or surgery | Cystoprostatectomy |
| external beam radiotherapyPatients with bladder infiltrating T4 prostate cancer are treated with adjuvant androgen deprivation therapy | Radiation | Radiotherapy |
Primary outcome
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.
5 secondary outcomes
Biochemical progression-free survival (BPFS)
Time frame: 10 years
Cancer-specific survival (CSS)
Time frame: 10 years
Functional Assessment of Cancer Therapy-General (FACT-G) score
Time frame: 10 years
Functional Assessment of Cancer Therapy-Prostate (FACT-P) score
Time frame: 10 years
complications
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhiqiang Chen, M.D.,Ph.D study chair
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cystoprostatectomy and external beam radiotherapy in people with Prostate Cancer, run by Tongji Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhiqiang Chen, M.D.,Ph.D (008613995512271, zhqchen8366@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2022.