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Personalized Mini-PDX for Metastatic CRPC

Primary Purpose

Prostate Cancer

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
MiniPDX Group
Sponsored by
Tianjin Medical University Second Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate Cancer, Patient Derived Xenograft, CRPC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patient can provide detailed clinical baseline information including: name, age, gender, pathology, past treatment, etc.;
  2. Male, age ≥ 18 years old;
  3. ECOG score 0~2 points;
  4. Patient must be able to provide tissue samples for the drug sensitive test;
  5. No treatment history with PI3K inhibitors, AKT inhibitors or mTOR inhibitors;
  6. Estimated lifetime is ≥ 3 months;
  7. Histological or cytologically determined prostate adenocarcinoma, excluding neuroendocrine differentiation, signet ring cell carcinoma and small cell carcinoma;
  8. Patient is at a castration level and the testosterone level is lower than <50 ng/dL or 1.7 nmol/L;
  9. Received abiraterone or enzalutamide and other new second-generation anti-androgenic drugs and have disease progression. Disease progression is defined by PCWG3 :The progression of disease in PCWG3 is defined as satisfying one of the following: according to the increase in PSA levels, there must be three consecutive increases in PSA at least one week apart, and the minimum value is greater than or equal to 5.0 ng/ml; disease progression as assessed by RECIST 1.1, considering PSA levels or not; PCWG3 defines bone disease progression, which is bone scan found 2 or more new lesions;
  10. Evidence of distant metastatic disease (such as bone scans and CT/MRI results), imaging data that can be used to assess the condition before and after treatment, or imaging experience provided by three imaging hospitals with experience in three hospitals. Test reports and oncology indicators include PSA values;
  11. The patient can tolerate the primary physician to perform the puncture operation, after receiving the informed consent from the patient and the family members;
  12. The follow-up period must be at least greater than 2 months;
  13. Be able to follow the research and follow-up procedures to provide real and effective information;
  14. The patient or his legal guardian understands the test procedure and content and voluntarily signs the printed informed consent form.

Exclusion Criteria:

  1. Cognitive ability and psychological abnormalities
  2. ECOG score 3-4 points or blood biochemical examination indicates that the patient is not suitable for continuing chemotherapy or chemotherapy has been postponed
  3. Can not provide enough tumor puncture tissue, not enough tumor cells for subsequent experiments;
  4. Patient who is unwilling to receive follow-up treatment after the Mini PDX model drug sensitivity test;
  5. The investigator believes that the subject may not be able to complete the study or may not be able to comply with the requirements of this study (for administrative reasons or other reasons).

Sites / Locations

  • Tianjin Medical University Second HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MiniPDX Group

Arm Description

Patients medication plan based on MiniPDX drug sensitivity test.

Outcomes

Primary Outcome Measures

ORR
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.

Secondary Outcome Measures

PFS
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
Overall survival is defined as time from initiation to death of any cause.
ADR
Adverse Drug Reaction:Adverse events determined according to CTCAE (version 4.03) and attribution to study treatment.
Clinical Consistency
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.

Full Information

First Posted
December 6, 2018
Last Updated
November 25, 2019
Sponsor
Tianjin Medical University Second Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03786848
Brief Title
Personalized Mini-PDX for Metastatic CRPC
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 28, 2019 (Actual)
Primary Completion Date
January 27, 2020 (Anticipated)
Study Completion Date
January 27, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Medical University Second Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators intend to use the Second-generation sequencing(NGS)and MiniPDX drug sensitivity models to guide the treatment decision-making for patients who were resistant to abiraterone, enzalutamide or other new second-generation anti-androgenic drugs. In order to develop precise personalized treatment plans for patients and extent their lifetimes.
Detailed Description
Most patients with metastatic prostate cancer are effective in endocrine therapy at the beginning, but after a median survival of 12 to 18 months, almost all patients develop castration-resistant prostate cancer (CRPC). Since the pathogenesis of CRPC is still unknown, the clinical lack of precise treatment for the cause is a difficult and hot topic in current research and treatment. 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 efficient drug sensitivity test can provide sensitivities of single drug or drug combination in order to screen out the optimal individualized regimens for each patient. The investigators intend to use the Second-generation sequencing(NGS)and MiniPDX drug sensitivity models to guide the treatment decision-making for patients who were resistant with abiraterone, enzalutamide or other new second-generation anti-androgenic drugs. This project is to develop precise personalized treatment plans for patients and extent their lifetimes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer, Patient Derived Xenograft, CRPC

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MiniPDX Group
Arm Type
Experimental
Arm Description
Patients medication plan based on MiniPDX drug sensitivity test.
Intervention Type
Other
Intervention Name(s)
MiniPDX Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
ORR
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
PFS
Description
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.
Time Frame
12 months
Title
OS
Description
Overall survival is defined as time from initiation to death of any cause.
Time Frame
12 months
Title
ADR
Description
Adverse Drug Reaction:Adverse events determined according to CTCAE (version 4.03) and attribution to study treatment.
Time Frame
Up to 30 days of last study treatment.
Title
Clinical Consistency
Description
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.
Time Frame
Up to 2 months of last study treatment.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient can provide detailed clinical baseline information including: name, age, gender, pathology, past treatment, etc.; Male, age ≥ 18 years old; ECOG score 0~2 points; Patient must be able to provide tissue samples for the drug sensitive test; No treatment history with PI3K inhibitors, AKT inhibitors or mTOR inhibitors; Estimated lifetime is ≥ 3 months; Histological or cytologically determined prostate adenocarcinoma, excluding neuroendocrine differentiation, signet ring cell carcinoma and small cell carcinoma; Patient is at a castration level and the testosterone level is lower than <50 ng/dL or 1.7 nmol/L; Received abiraterone or enzalutamide and other new second-generation anti-androgenic drugs and have disease progression. Disease progression is defined by PCWG3 :The progression of disease in PCWG3 is defined as satisfying one of the following: according to the increase in PSA levels, there must be three consecutive increases in PSA at least one week apart, and the minimum value is greater than or equal to 5.0 ng/ml; disease progression as assessed by RECIST 1.1, considering PSA levels or not; PCWG3 defines bone disease progression, which is bone scan found 2 or more new lesions; Evidence of distant metastatic disease (such as bone scans and CT/MRI results), imaging data that can be used to assess the condition before and after treatment, or imaging experience provided by three imaging hospitals with experience in three hospitals. Test reports and oncology indicators include PSA values; The patient can tolerate the primary physician to perform the puncture operation, after receiving the informed consent from the patient and the family members; The follow-up period must be at least greater than 2 months; Be able to follow the research and follow-up procedures to provide real and effective information; The patient or his legal guardian understands the test procedure and content and voluntarily signs the printed informed consent form. Exclusion Criteria: Cognitive ability and psychological abnormalities ECOG score 3-4 points or blood biochemical examination indicates that the patient is not suitable for continuing chemotherapy or chemotherapy has been postponed Can not provide enough tumor puncture tissue, not enough tumor cells for subsequent experiments; Patient who is unwilling to receive follow-up treatment after the Mini PDX model drug sensitivity test; The investigator believes that the subject may not be able to complete the study or may not be able to comply with the requirements of this study (for administrative reasons or other reasons).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haitao Wang, Ph.D
Phone
+86-022-88326385
Email
peterrock2000@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haitao Wang
Organizational Affiliation
Tianjin Medical University Second Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tianjin Medical University Second Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300211
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haitao Wang

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30257718
Citation
Zhang F, Wang W, Long Y, Liu H, Cheng J, Guo L, Li R, Meng C, Yu S, Zhao Q, Lu S, Wang L, Wang H, Wen D. Characterization of drug responses of mini patient-derived xenografts in mice for predicting cancer patient clinical therapeutic response. Cancer Commun (Lond). 2018 Sep 26;38(1):60. doi: 10.1186/s40880-018-0329-5.
Results Reference
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Personalized Mini-PDX for Metastatic CRPC

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