Predictive Nomogram of CRPC (CRPC-PN)

Tianjin Medical University Second Hospital

Status: Unknown

Conditions: Metastatic Cancer; Castration-resistant Prostate Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT03177551

CRPC-PN

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

300 participants in 2 patient groups

Developement Cohort

Description:

Development the Predictive Nomogram for mCRPC in Patients with Prostate Cancer

Validation Cohort

Description:

Validation the Predictive Nomogram for mCRPC in Patients with Prostate Cancer