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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RECRUITING
NA
80 participants
INTERVENTIONAL
2018-06-28
2024-12-31
Brief Summary
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Detailed Description
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Study Groups:
After inclusion, patients requesting local treatment can undergo radical prostatectomy (RP) with pelvic lymph-node dissection (PLND) after multi-disciplinary evaluation. This resulting in a local treatment group and a no local treatment group. For ethical reasons, no randomization will be done.
Follow-up:
Patients not undergoing local treatment will undergo the current standard of care in our institution. And besides the intervention of local treatment, the other patients will receive this same current standard of care.
Routine follow-up visits, with physical examination, laboratory tests and questionnaires, will be scheduled every 3 months. A CT-scan (abdomen-pelvis) and bone scan will be performed if a clinical progression is diagnosed or suspected and when Castration Refractory PCa (CRPC) is established.
Androgen Deprivation Therapy (ADT) will be initiated in case of one of the following:
* symptoms related to metastatic lesion(s)
* Prostate Specific Antigen (PSA) \> 50ng/ml and doubling time (PSA-DT) \< 6 months (starting 3 months after inclusion at earliest)
The estimated number of patients to be included in the local treatment arm is 40.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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No local treatment
Routine care in metastatic prostate cancer.
No interventions assigned to this group
Local treatment
Radical Prostatectomy (RP) + routine care in metastatic prostate cancer.
Radical Prostatectomy (RP)
Radical Prostatectomy with extended Pelvic Lymph Node Dissection within 8 weeks after inclusion.
Interventions
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Radical Prostatectomy (RP)
Radical Prostatectomy with extended Pelvic Lymph Node Dissection within 8 weeks after inclusion.
Eligibility Criteria
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Inclusion Criteria
* Newly diagnosis of metastatic disease (stage TanyNanyM+)
* Life expectancy ≥2y based on comorbid conditions, WHO performance status 0-2
* Written informed consent, male ≥18yo
* Willing and expected to comply with study protocol and follow-up schedule
* Multidisciplinary Oncologic Consultation (MOC) approval
Exclusion Criteria
* Metastatic brain disease, leptomeningeal disease or imminent spinal cord compression
* Symptoms clearly related to metastatic lesions
* Any other previous or current (malignant) disease which, in the judgment of the responsible physician, is likely to interfere with LoMP treatment or assessment
18 Years
85 Years
MALE
No
Sponsors
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University Hospital, Ghent
OTHER
Responsible Party
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Principal Investigators
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Nicolaas Lumen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Ghent
Locations
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ASZ Aalst
Aalst, , Belgium
Imelda Ziekenhuis
Bonheiden, , Belgium
University Hospital, Ghent
Ghent, , Belgium
Sint-Fransiskusziekenhuis
Heusden-Zolder, , Belgium
AZ Jan Portaels
Vilvoorde, , Belgium
Countries
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Central Contacts
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References
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Poelaert F, Verbaeys C, Rappe B, Kimpe B, Billiet I, Plancke H, Decaestecker K, Fonteyne V, Buelens S, Lumen N. Cytoreductive Prostatectomy for Metastatic Prostate Cancer: First Lessons Learned From the Multicentric Prospective Local Treatment of Metastatic Prostate Cancer (LoMP) Trial. Urology. 2017 Aug;106:146-152. doi: 10.1016/j.urology.2017.02.051. Epub 2017 Apr 20.
Other Identifiers
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B670201420709
Identifier Type: -
Identifier Source: org_study_id