Cytoreductive Prostatectomy Versus Cytoreductive Prostate Irradiation as a Local Treatment Option for Metastatic Prostate Cancer: a Multicentric Feasibility Trial

Study Overview
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Brief Summary
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According to the guidelines of the European Association of Urology (EAU), the first-line treatment for newly diagnosed mPC consists of immediate castration with the addition of docetaxel or abiraterone acetate. As seen in other well-known solid tumours - such as ovarian, colon and renal cancer - local treatment (LT) of the primary tumour could lead to a survival benefit compared to standard of care (SOC). Several retrospective studies have suggested a survival benefit of local treatment of the primary tumour with SOC versus SOC only in mPC. These patients also have less local symptoms of their disease, which has a major impact on quality of life (QoL). Several prospective studies have already been set up to compare either surgery or radiotherapy with the SOC. In expectation of their results and because randomization seems challenging, the investigators want to set up a trial to evaluate the feasibility of randomization between both local treatment groups.

Official Title
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Cytoreductive Prostatectomy Versus Cytoreductive Prostate Irradiation as a Local Treatment Option for Metastatic Prostate Cancer: a Multicentric Feasibility Trial

Conditions
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Prostate Cancer Metastatic

Intervention / Treatment
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* Procedure: radical prostatectomy
* Radiation: Whole pelvis radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male ≥18y Histologically proven PC Newly diagnosed metastatic PC as assessed by standard imaging (CT and bone scintigraphy) ECOG 0-1 (2 if related to local PC symptoms) Eligible for local treatment Written informed consent and able and willing to comply with protocol requirements Exclusion Criteria: Previous systemic treatment for PC except ADT started within 3 months before randomization Previous radiotherapy to the pelvis interfering with prostate irradiation Previous surgery in the pelvis interfering with radical prostatectomy Symptoms related to metastatic lesions, persisting for at least 2 weeks after initiation of ADT Metastatic brain disease, leptomeningeal disease or imminent spinal cord compression Previous or current malignant disease which is likely to interfere with LoMP II treatment or assessment Psychological disorder intervening with understanding the information or the informed consent

Ages Eligible for Study
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Minimum Age: 18 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radical prostatectomy<br> | Procedure: radical prostatectomy<br>* can be performed either open, laparoscopic or robot-assisted, which is chosen by the discretion and expertise of the performing surgeon<br>|
| Experimental: Radiotherapy<br> | Radiation: Whole pelvis radiotherapy<br>* radiation of prostate bed and pelvis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of randomization between both treatment arms as assessed by the randomized proportion | In this trial we want to assess whether it is feasible to randomize patients into both treatment arms. All patients eligible for inclusion will be reported. The eventual proportion of randomized patients will be evaluated. Reasons for exclusion will be monitored. | 48 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| castration-resistant free survival | Calculated starting from date of randomization until castration-resistant disease development, as defined by the European Association of Urology (EAU) guidelines | 48 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metastatic, prostate cancer, local, cytoreductive