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出境医 / 临床实验 / Testing Radical Prostatectomy in Chinese Men With Prostate Cancer and oligoMetastases to the Bone
Testing Radical Prostatectomy in Chinese Men With Prostate Cancer and oligoMetastases to the Bone
Study Description
Brief Summary:
This study is to examine whether radical prostatectomy can impact survival and quality-of-life in men with oligo-metastatic prostate cancer.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Prostate Cancer Metastatic | Procedure: Radical prostatectomy plus standard care Drug: Standard of care for metastatic prostate cancer | Not Applicable |
Detailed Description:
In this study, patients with oligo-metastatic prostate cancer will be randomized to radical prostatectomy plus standard care and standard care only. Standard care refers to androgen deprivation therapy (ADT) +/- other systemic therapies. Time to disease progression and post-treatment quality of life will be assessed and compared.
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 120 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Zhongshan Hospital, Fudan University |
| Actual Study Start Date : | April 1, 2019 |
| Estimated Primary Completion Date : | March 31, 2021 |
| Estimated Study Completion Date : | March 31, 2022 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Intervention Group
Radical prostatectomy plus standard care
|
Procedure: Radical prostatectomy plus standard care
To add radical prostatectomy on the basis of current standard of care for those with oligometastatic prostate cancer
Drug: Standard of care for metastatic prostate cancer androgen deprivation therapy with or without other systemic therapies based on current guidelines for metastatic prostate cancer
|
|
Active Comparator: Comparator Group
Standard care, currently ADT +/- other systemic therapies.
|
Drug: Standard of care for metastatic prostate cancer
androgen deprivation therapy with or without other systemic therapies based on current guidelines for metastatic prostate cancer
|
Outcome Measures
Primary Outcome Measures :
- the time to castrate resistance [ Time Frame: 36 months after randomization ]The time to treatment failure defined as castrate resistance will be recorded via routine patient follow-up interviews.
Secondary Outcome Measures :
- Quality of life in patients post-randomization [ Time Frame: three month post randomization ]EuroQOL 5 dimensions 5 levels (EQ-5D-5L) questionnaire will be used to assess quality of life in patients after randomization with different treatments. This is designed to measure health-related quality of life. It consists of a questionnaire and a visual analogue scale. The subjects in 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression are asked to grade their own current level of function in each dimension into one of five levels of disability (i.e. I have no problems waling about, slight problems, moderate problems, severe problems, or unable to walk). This tool also has an overall health scale where the rater selects a number between 1-100 to describe the condition of their health, 100 being the best imaginable.
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Participants is willing and able to give informed consent for participation in the study
- Male aged 19-75 years.
- Diagnosed with oligo-metastatic prostate cancer (1-3 skeletal lesions on bone specific imaging, no visceral metastases).
- Locally resectable tumor (clinical/radiological stage T1-T3).
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Suitable for radical prostatectomy within 12 months of starting standard care.
Exclusion Criteria:
- Contraindications to radical prostatectomy.
- Visceral metastases.
- Prior radiotherapy to the abdomen/pelvis or to skeletal metastases.
- Any systemic therapy of prostate cancer (including standard care) for 12 or more months prior to enrollment.
- Current involvement in other interventional research.
Contacts and Locations
Contacts
| Contact: Jian-Ming Guo, MD, PhD | +86 13681971306 | guo.jianming@zs-hospital.sh.cn | |
| Contact: Lei Xu, MD, PhD | +86 18616139981 | xu.lei1@zs-hospital.sh.cn |
Locations
| China, Shanghai | |
| Zhongshan Hospital, Fudan University | Recruiting |
| Shanghai, Shanghai, China, 200032 | |
| Contact: Jian-Ming Guo, MD, PhD +86 13681971306 guo.jianming@zs-hospital.sh.cn | |
| Contact: Lei Xu, MD, PhD +86 18616139981 xu.lei1@zs-hospital.sh.cn | |
Sponsors and Collaborators
Fudan University
University College, London
Investigators
| Principal Investigator: | Jian-Ming Guo, MD, PhD | Fudan University |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 8, 2019 | ||||||||
| First Posted Date ICMJE | June 17, 2019 | ||||||||
| Last Update Posted Date | June 17, 2019 | ||||||||
| Actual Study Start Date ICMJE | April 1, 2019 | ||||||||
| Estimated Primary Completion Date | March 31, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
the time to castrate resistance [ Time Frame: 36 months after randomization ] The time to treatment failure defined as castrate resistance will be recorded via routine patient follow-up interviews.
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
Quality of life in patients post-randomization [ Time Frame: three month post randomization ] EuroQOL 5 dimensions 5 levels (EQ-5D-5L) questionnaire will be used to assess quality of life in patients after randomization with different treatments. This is designed to measure health-related quality of life. It consists of a questionnaire and a visual analogue scale. The subjects in 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression are asked to grade their own current level of function in each dimension into one of five levels of disability (i.e. I have no problems waling about, slight problems, moderate problems, severe problems, or unable to walk). This tool also has an overall health scale where the rater selects a number between 1-100 to describe the condition of their health, 100 being the best imaginable.
|
||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Testing Radical Prostatectomy in Chinese Men With Prostate Cancer and oligoMetastases to the Bone | ||||||||
| Official Title ICMJE | Zhongshan Hospital, Fudan University | ||||||||
| Brief Summary | This study is to examine whether radical prostatectomy can impact survival and quality-of-life in men with oligo-metastatic prostate cancer. | ||||||||
| Detailed Description | In this study, patients with oligo-metastatic prostate cancer will be randomized to radical prostatectomy plus standard care and standard care only. Standard care refers to androgen deprivation therapy (ADT) +/- other systemic therapies. Time to disease progression and post-treatment quality of life will be assessed and compared. | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE | Prostate Cancer Metastatic | ||||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
120 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | March 31, 2022 | ||||||||
| Estimated Primary Completion Date | March 31, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | China | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03988686 | ||||||||
| Other Study ID Numbers ICMJE | B2019-065 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||||||
| Responsible Party | Jianming Guo, Fudan University | ||||||||
| Study Sponsor ICMJE | Fudan University | ||||||||
| Collaborators ICMJE | University College, London | ||||||||
| Investigators ICMJE |
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| PRS Account | Fudan University | ||||||||
| Verification Date | June 2019 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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