Local Treatment With RP for Newly-diagnosed mPCa (LoMP)
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|ClinicalTrials.gov Identifier: NCT02138721|
Recruitment Status : Unknown
Verified May 2017 by University Hospital, Ghent.
Recruitment status was: Recruiting
First Posted : May 15, 2014
Last Update Posted : May 5, 2017
|Condition or disease||Intervention/treatment||Phase|
|Prostatic Neoplasms Neoplasm Metastasis||Procedure: Radical Prostatectomy (RP)||Not Applicable|
Patients recently diagnosed with metastatic prostate cancer (mPCa), and meeting the eligibility criteria, will be given the opportunity to enroll in this study.
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.
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Local Treatment With Radical Prostatectomy (RP) for Newly-diagnosed Metastatic Prostate Cancer (mPCa).|
|Study Start Date :||May 2014|
|Estimated Primary Completion Date :||May 2019|
|Estimated Study Completion Date :||May 2019|
No Intervention: No local treatment
Routine care in metastatic prostate cancer.
Experimental: Local treatment
Radical Prostatectomy (RP) + routine care in metastatic prostate cancer.
Procedure: Radical Prostatectomy (RP)
Radical Prostatectomy with extended Pelvic Lymph Node Dissection within 8 weeks after inclusion.
- 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]
- 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]
- 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]
- 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]
- Quality of Life [ Time Frame: at month 6 - 12 ]Evaluated by the EuroQoL 5 Dimensions 5 Levels Questionnaire
- 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]
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02138721
|Contact: Nicolaas Lumen, MD, PhDfirstname.lastname@example.org|
|University Hospital, Ghent||Recruiting|
|Ghent, Belgium, 9000|
|AZ Jan Portaels||Recruiting|
|Principal Investigator:||Nicolaas Lumen, MD, PhD||University Hospital, Ghent|