Local Treatment With RP for Newly-diagnosed mPCa

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Local Treatment With Radical Prostatectomy (RP) for Newly-diagnosed Metastatic Prostate Cancer (mPCa).

Conditions
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Prostatic Neoplasms, Neoplasm Metastasis

Intervention / Treatment
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* Procedure: Radical Prostatectomy (RP)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No local treatment<br>Routine care in metastatic prostate cancer. | |
| Experimental: Local treatment<br>Radical Prostatectomy (RP) + routine care in metastatic prostate cancer. | Procedure: Radical Prostatectomy (RP)<br>* Radical Prostatectomy with extended Pelvic Lymph Node Dissection within 8 weeks after inclusion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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] | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metastatic Prostate Cancer, Prostatectomy