- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02138721
Local Treatment With RP for Newly-diagnosed mPCa (LoMP)
Local Treatment With Radical Prostatectomy (RP) for Newly-diagnosed Metastatic Prostate Cancer (mPCa).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients recently diagnosed with metastatic prostate cancer (mPCa), and meeting the eligibility criteria, will be given the opportunity to enroll in this study.
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nicolaas Lumen, MD, PhD
- Email: nicolaas.lumen@uzgent.be
Study Locations
-
-
-
Aalst, Belgium
- Recruiting
- ASZ Aalst
-
Bonheiden, Belgium
- Recruiting
- Imelda Ziekenhuis
-
Ghent, Belgium, 9000
- Recruiting
- University Hospital, Ghent
-
Heusden-Zolder, Belgium
- Recruiting
- Sint-Fransiskusziekenhuis
-
Vilvoorde, Belgium
- Recruiting
- AZ Jan Portaels
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosis of prostate adenocarcinoma, confirmed by histology
- 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:
- Previous local or systemic treatment for prostate cancer
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: No local treatment
Routine care in metastatic prostate cancer.
|
|
Experimental: Local treatment
Radical Prostatectomy (RP) + routine care in metastatic prostate cancer.
|
Radical Prostatectomy with extended Pelvic Lymph Node Dissection within 8 weeks after inclusion.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Castration Refractory Prostate Cancer Progression-Free Survival
Time Frame: up to 10 years
|
From date of inclusion until the date of Castration Refractory Prostate Cancer (CRPC) defined according to European Association of Urology (EAU) guidelines, or date of death from any cause, whichever came first, assessed up to 10 years.
[months]
|
up to 10 years
|
Time to first Disease Related Event
Time Frame: up to 10 years
|
From date of inclusion until the date of any event related to local disease progression (eg ureter obstruction, bladder outlet obstruction), any Skeletal Related Event (SRE) or any event related to metastasis (eg lymphedema).
[months]
|
up to 10 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival
Time Frame: at year 1 - 2 - 5
|
From date of inclusion until the date of death from any cause, assessed up to 10 years.
[months]
|
at year 1 - 2 - 5
|
Prostate Cancer Specific Survival
Time Frame: at year 1 - 2 - 5
|
From date of inclusion until the date of death due to prostate cancer, assessed up to 10 years.
[months]
|
at year 1 - 2 - 5
|
Quality of Life
Time Frame: at month 6 - 12
|
Evaluated by the EuroQoL 5 Dimensions 5 Levels Questionnaire
|
at month 6 - 12
|
Time to Androgen Deprivation Therapy start
Time Frame: up to 10 years, estimated to occur within 24 months
|
From date of inclusion until the date of start of Androgen Deprivation Therapy (ADT) (criteria described in protocol) [months]
|
up to 10 years, estimated to occur within 24 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cytoreductive effect of local treatment in metastatic disease lesions [%]
Time Frame: at month 3 - 6
|
Tumor burden assessment will be performed by image-based evaluation (RECIST criteria v1.1) when possible.
|
at month 3 - 6
|
Cost-effectiveness of local treatment arm versus no local treatment arm
Time Frame: analysis after trial ending, estimated in 10-15 years
|
Evaluation of cost [€] and quality-adjusted life years [QALYs] related to interventions needed in both arms from inclusion to death.
|
analysis after trial ending, estimated in 10-15 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nicolaas Lumen, MD, PhD, University Hospital, Ghent
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- B670201420709
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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