Castration-resistant Prostate Cancer, Metastatic Cancer
Conditions
Keywords
Prostatic Neoplasms, Nomograms, Drug Resistance, Neoplasm
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.
Detailed 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.
Interventions
None listed
Sponsors
Tianjin Medical University Second Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to castration resistant | 3 YEARS | 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. |
Countries
China
Contacts
Primary ContactShimiao Zhu, MD,PhD
Outcome results
None listed