Predictive Nomogram of CRPC

Metastatic Cancer Clinical Trial

— CRPC-PN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03177551
• Other study ID #: CRPC-PN
• Status: Recruiting
• Start date: May 4, 2017
• Est. completion date: May 2020

Study information

• Verified date: September 2018
• Source: Tianjin Medical University Second Hospital
• Contact: Shimiao Zhu, MD,PhD
• Phone: +8613752436539
• Email: zhushimiao[@]tijmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: May 2020
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Castration-resistant Prostate Cancer
• Metastatic Cancer
• Neoplasm Metastasis
• Prostatic Neoplasms

Locations

Country	Name	City	State
China	Tianjin Medical Unversity Second Hospital	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Second Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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