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The objective of this study is to evaluate the role of local treatment with radical prostatectomy in patients with newly-diagnosed metastatic hormone-sensitive prostate cancer.
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:
The estimated number of patients to be included in the local treatment arm is 40.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No local treatment | No Intervention | Routine care in metastatic prostate cancer. | |
| Local treatment | Experimental | Radical Prostatectomy (RP) + routine care in metastatic prostate cancer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radical Prostatectomy (RP) | Procedure | Radical Prostatectomy with extended Pelvic Lymph Node Dissection within 8 weeks after inclusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Castration Refractory Prostate Cancer Progression-Free Survival | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | 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 | From date of inclusion until the date of death due to prostate cancer, assessed up to 10 years. [months] |
| Measure | Description | Time Frame |
|---|---|---|
| Cytoreductive effect of local treatment in metastatic disease lesions [%] | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicolaas Lumen, MD, PhD | Contact | nicolaas.lumen@uzgent.be |
| Name | Affiliation | Role |
|---|---|---|
| Nicolaas Lumen, MD, PhD | University Hospital, Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ASZ Aalst | Recruiting | Aalst | Belgium | |||
| Imelda Ziekenhuis |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28435034 | Result | 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. |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| at year 1 - 2 - 5 |
| Quality of Life | Evaluated by the EuroQoL 5 Dimensions 5 Levels Questionnaire | at month 6 - 12 |
| Time to Androgen Deprivation Therapy start | 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 |
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 |
| Recruiting |
| Bonheiden |
| Belgium |
| University Hospital, Ghent | Recruiting | Ghent | 9000 | Belgium |
| Sint-Fransiskusziekenhuis | Recruiting | Heusden-Zolder | Belgium |
| AZ Jan Portaels | Recruiting | Vilvoorde | Belgium |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |