Testing Radical Prostatectomy in Chinese Men With Prostate Cancer and oligoMetastases to the Bone

Study Overview
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Brief Summary
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This study is to examine whether radical prostatectomy can impact survival and quality-of-life in men with oligo-metastatic prostate cancer.

Detailed Description
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In this study, patients with oligo-metastatic prostate cancer will be randomized to radical prostatectomy plus standard care and standard care only. Standard care refers to androgen deprivation therapy (ADT) +/- other systemic therapies. Time to disease progression and post-treatment quality of life will be assessed and compared.

Official Title
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Zhongshan Hospital, Fudan University

Conditions
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Prostate Cancer Metastatic

Intervention / Treatment
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* Procedure: Radical prostatectomy plus standard care
* Drug: Standard of care for metastatic prostate cancer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants is willing and able to give informed consent for participation in the study Male aged 19-75 years. Diagnosed with oligo-metastatic prostate cancer (1-3 skeletal lesions on bone specific imaging, no visceral metastases). Locally resectable tumor (clinical/radiological stage T1-T3). Eastern Cooperative Oncology Group (ECOG) performance status 0-1. Suitable for radical prostatectomy within 12 months of starting standard care. Exclusion Criteria: Contraindications to radical prostatectomy. Visceral metastases. Prior radiotherapy to the abdomen/pelvis or to skeletal metastases. Any systemic therapy of prostate cancer (including standard care) for 12 or more months prior to enrollment. Current involvement in other interventional research.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Intervention Group<br>Radical prostatectomy plus standard care | Procedure: Radical prostatectomy plus standard care<br>* To add radical prostatectomy on the basis of current standard of care for those with oligometastatic prostate cancer<br>Drug: Standard of care for metastatic prostate cancer<br>* androgen deprivation therapy with or without other systemic therapies based on current guidelines for metastatic prostate cancer<br>|
| Active Comparator: Comparator Group<br>Standard care, currently ADT +/- other systemic therapies. | Drug: Standard of care for metastatic prostate cancer<br>* androgen deprivation therapy with or without other systemic therapies based on current guidelines for metastatic prostate cancer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the time to castrate resistance | The time to treatment failure defined as castrate resistance will be recorded via routine patient follow-up interviews. | 36 months after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life in patients post-randomization | EuroQOL 5 dimensions 5 levels (EQ-5D-5L) questionnaire will be used to assess quality of life in patients after randomization with different treatments. This is designed to measure health-related quality of life. It consists of a questionnaire and a visual analogue scale. The subjects in 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression are asked to grade their own current level of function in each dimension into one of five levels of disability (i.e. I have no problems waling about, slight problems, moderate problems, severe problems, or unable to walk). This tool also has an overall health scale where the rater selects a number between 1-100 to describe the condition of their health, 100 being the best imaginable. | three month post randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oligometastasis, prostate cancer, radical prostatectomy, progression-free survival, quality of life