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| Name | Class |
|---|---|
| University College, London | OTHER |
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This study is to examine whether radical prostatectomy can impact survival and quality-of-life in men with oligo-metastatic prostate cancer.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Radical prostatectomy plus standard care |
|
| Comparator Group | Active Comparator | Standard care, currently ADT +/- other systemic therapies. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radical prostatectomy plus standard care | Procedure | To add radical prostatectomy on the basis of current standard of care for those with oligometastatic prostate cancer |
|
| Measure | Description | Time Frame |
|---|---|---|
| the time to castrate resistance | The time to treatment failure defined as castrate resistance will be recorded via routine patient follow-up interviews. | 36 months after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life in patients 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jian-Ming Guo, MD, PhD | Contact | +86 13681971306 | guo.jianming@zs-hospital.sh.cn | |
| Lei Xu, MD, PhD | Contact | +86 18616139981 | xu.lei1@zs-hospital.sh.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jian-Ming Guo, MD, PhD | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital, Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard of care for metastatic prostate cancer | Drug | androgen deprivation therapy with or without other systemic therapies based on current guidelines for metastatic prostate cancer |
|
| three month post randomization |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |