Testing Radical Prostatectomy in Chinese Men With Prostate Cancer and oligoMetastases to the Bone
NCT ID: NCT03988686
Last Updated: 2019-06-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2019-04-01
2022-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention Group
Radical prostatectomy plus standard care
Radical prostatectomy plus standard care
To add radical prostatectomy on the basis of current standard of care for those with oligometastatic prostate cancer
Standard of care for metastatic prostate cancer
androgen deprivation therapy with or without other systemic therapies based on current guidelines for metastatic prostate cancer
Comparator Group
Standard care, currently ADT +/- other systemic therapies.
Standard of care for metastatic prostate cancer
androgen deprivation therapy with or without other systemic therapies based on current guidelines for metastatic prostate cancer
Interventions
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Radical prostatectomy plus standard care
To add radical prostatectomy on the basis of current standard of care for those with oligometastatic prostate cancer
Standard of care for metastatic prostate cancer
androgen deprivation therapy with or without other systemic therapies based on current guidelines for metastatic prostate cancer
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
MALE
No
Sponsors
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University College, London
OTHER
Fudan University
OTHER
Responsible Party
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Jianming Guo
Professor
Principal Investigators
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Jian-Ming Guo, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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B2019-065
Identifier Type: -
Identifier Source: org_study_id
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