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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03177551
Other study ID # CRPC-PN
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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;

Study Design


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
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