Personalized Mini-PDX for Metastatic CRPC
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03786848|
Recruitment Status : Recruiting
First Posted : December 25, 2018
Last Update Posted : April 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Other: MiniPDX Group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single-center, Open, Real World and Prospective Trial of Personalized Mini Patient-Derived Xenograft (MiniPDX ) Modeling in Adult Patients With Metastatic Castration Resistant Prostate Cancer|
|Actual Study Start Date :||January 28, 2019|
|Estimated Primary Completion Date :||June 27, 2019|
|Estimated Study Completion Date :||November 30, 2019|
Experimental: MiniPDX Group
Patients medication plan based on MiniPDX drug sensitivity test.
Other: MiniPDX Group
Mini patient derived xenograft (MiniPDX) is a drug sensitivity test model established by transplanting primary human tumor cells into immunodeficient mice by special methods. This test can provide sensitivities of single drug or drug combination within 7 days to screen out the optimal individualized regimens for each patient.
- ORR [ Time Frame: 12 months ]The ratio of number of participants with evidence of a confirmed complete response (CR) or partial response (PR) to all participants is objective response rate (ORR) by using Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 to evaluate.
- PFS [ Time Frame: 12 months ]Progression-free survival (PFS) is defined as the time from the date of the first administration of patients medication plan based on MiniPDX drug sensitivity test to the date of the first documentation of disease progression or death due to any cause, whichever comes first, censored at the last date at which the participant was determined to be progression-free.
- OS [ Time Frame: 12 months ]Overall survival is defined as time from initiation to death of any cause.
- ADR [ Time Frame: Up to 30 days of last study treatment. ]Adverse Drug Reaction：Adverse events determined according to CTCAE (version 4.03) and attribution to study treatment.
- Clinical Consistency [ Time Frame: Up to 2 months of last study treatment. ]Overall clinical consistency（accuracy） as assessed by evaluating Response Evaluation Criteria In Solid Tumors (RECIST) criteria in patient tumor and correlating to tumor regression in Mini-PDX model for same drug treatment.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03786848
|Contact: Haitao Wang, Ph.Demail@example.com|
|Tianjin Medical University Second Hospital||Recruiting|
|Tianjin, Tianjin, China, 300211|
|Contact: Haitao Wang|
|Principal Investigator:||Haitao Wang||Tianjin Medical University Second Hospital|