Predictive Nomogram of CRPC

NCT03177551 | Unknown DMC

• 1 other identifier: CRPC-PN
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Castration-resistant Prostate Cancer; Metastatic Cancer

Keywords

Prostatic Neoplasms; Nomograms; Drug Resistance, Neoplasm

Outcome Measures

Primary Outcomes (1)

• Time to castration resistant

  The definition mCRPC is that the castrated androgen \< 50 ng/dL or 1.7 nmol/L plus either; 1. 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, 2. 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

Study Arms (2)

Developement Cohort

Development the Predictive Nomogram for mCRPC in Patients with Prostate Cancer

Validation Cohort

Validation the Predictive Nomogram for mCRPC in Patients with Prostate Cancer

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male only
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants having indication and planning to receiving ADT.

You may qualify if:

• 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.

You may not qualify if:

• Participants with previous history of ADT;
• Participants who are allergic to contrast medium;
• Participants who failed to regulate endocrine therapy with the orders requirements;

Sponsors & Collaborators

• Tianjin Medical University Second Hospital: lead

Study Sites (1)

Tianjin Medical Unversity Second Hospital

Tianjin, 300211, China

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis; Prostatic Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Yuanjie Niu, MD,PhD

  Tianjin Medical University Second Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shimiao Zhu, MD,PhD

CONTACT

+8613752436539; zhushimiao@tijmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2017
• First Posted: June 6, 2017
• Study Start: May 4, 2017
• Primary Completion: September 1, 2019
• Study Completion: May 1, 2020
• Last Updated: October 1, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)