Clinical trial NCT03177551: Predictive Nomogram of CRPC
Official title: Development and Validation of Predictive Nomogram for Castration Resistant to Androgen Deprivation Therapy in Patients With Advanced Prostate Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Castration-resistant Prostate Cancer
Metastatic Cancer
Keywords: Prostatic Neoplasms
Nomograms
Drug Resistance, Neoplasm
Lead sponsor: Tianjin Medical University Second Hospital
Sponsor class: OTHER
First posted: 2017-06-06
Enrollment: 300
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants having indication and planning to receiving ADT.

Brief summary: 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: 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.

Eligibility criteria: 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;

Primary outcomes:
measure: Time to castration resistant
timeFrame: 3 YEARS
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical Unversity Second Hospital
Study officials:
affiliation: Tianjin Medical University Second Hospital
name: Yuanjie Niu, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: