Predictive Nomogram of CRPC

Study Overview
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Brief Summary
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This is an observational, prospective (study following participants forward in time), multi-center (study conducted in more than 1 center) study to identify the risk factors, then develop and validate the predictive Nomogram of metastatic castration-resistant prostate cancer (mCRPC) that will effectively predict the early onset mCRPC in patients receiving androgen-deprivation therapy (ADT). The entire duration of study will be approximately 3 year. Participants will primarily be evaluated for achieving biochemical or radiological progression after receiving ADT based on EAU 2017 practice guideline criteria. Serum testosterone, prostate specific antigen (PSA), alkaline phosphatase (ALP) and blood routine will be monitored throughout the study.

Detailed Description
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This is an observational, prospective (study following participants forward in time), multi-center (study conducted in more than 1 center) study to identify the risk factors, then develop and validate the predictive Nomogram of metastatic castration-resistant prostate cancer (mCRPC) that will effectively predict the early onset mCRPC in patients receiving androgen-deprivation therapy (ADT). The entire duration of study will be approximately 3 year. Participants will primarily be evaluated for achieving biochemical or radiological progression after receiving ADT based on EAU 2017 practice guideline criteria. Serum testosterone, prostate specific antigen (PSA), alkaline phosphatase (ALP) and blood routine will be monitored throughout the study.

Official Title
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Development and Validation of Predictive Nomogram for Castration Resistant to Androgen Deprivation Therapy in Patients With Advanced Prostate Cancer

Conditions
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Castration-resistant Prostate Cancer, Metastatic Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants who have given consent form; Participants with pathologically defined prostate cancer; Participants with life expectancy of at least 6 months based on the Investigator's clinical judgment; Participants having indication and planning to receiving ADT. Exclusion Criteria: Participants with previous history of ADT; Participants who are allergic to contrast medium; Participants who failed to regulate endocrine therapy with the orders requirements;

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Developement Cohort<br>Development the Predictive Nomogram for mCRPC in Patients with Prostate Cancer | |
| Validation Cohort<br>Validation the Predictive Nomogram for mCRPC in Patients with Prostate Cancer | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to castration resistant | The definition mCRPC is that the castrated androgen < 50 ng/dL or 1.7 nmol/L plus either; Biochemical progression: Three consecutive rises in PSA one week apart resulting in two 50% increases over the nadir, and a PSA > 2 ng/mL or, Radiological progression: The appearance of new lesions: either two or more new bone lesions on bone scan or a soft tissue lesion using RECIST (Response Evaluation Criteria in Solid Tumours) [736]. Symptomatic progression alone must be questioned and subject to further investigation. | 3 YEARS | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostatic Neoplasms, Nomograms, Drug Resistance, Neoplasm