Predictive Nomogram of CRPC

NCT ID: NCT03177551

Last Updated: 2018-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-04

Study Completion Date

2020-05-31

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.

Conditions

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Castration-resistant Prostate Cancer Metastatic Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Developement Cohort

Development the Predictive Nomogram for mCRPC in Patients with Prostate Cancer

No interventions assigned to this group

Validation Cohort

Validation the Predictive Nomogram for mCRPC in Patients with Prostate Cancer

No interventions assigned to this group

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;
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Tianjin Medical University Second Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yuanjie Niu, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Tianjin Medical University Second Hospital

Locations

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Tianjin Medical Unversity Second Hospital

Tianjin, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shimiao Zhu, MD,PhD

Role: CONTACT

+8613752436539

Facility Contacts

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Rong Han

Role: primary

+86 022 8832 8677

Other Identifiers

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CRPC-PN

Identifier Type: -

Identifier Source: org_study_id

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