<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03786848</url>
  </required_header>
  <id_info>
    <org_study_id>MiniPDX-CRPC</org_study_id>
    <nct_id>NCT03786848</nct_id>
  </id_info>
  <brief_title>Personalized Mini-PDX for Metastatic CRPC</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tianjin Medical University Second Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tianjin Medical University Second Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators intend to use the Second-generation sequencing（NGS）and MiniPDX drug&#xD;
      sensitivity models to guide the treatment decision-making for patients who were resistant to&#xD;
      abiraterone, enzalutamide or other new second-generation anti-androgenic drugs. In order to&#xD;
      develop precise personalized treatment plans for patients and extent their lifetimes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Most patients with metastatic prostate cancer are effective in endocrine therapy at the&#xD;
      beginning, but after a median survival of 12 to 18 months, almost all patients develop&#xD;
      castration-resistant prostate cancer (CRPC). Since the pathogenesis of CRPC is still unknown,&#xD;
      the clinical lack of precise treatment for the cause is a difficult and hot topic in current&#xD;
      research and treatment. Mini patient derived xenograft (MiniPDX) is a drug sensitivity test&#xD;
      model established by transplanting primary human tumor cells into immunodeficient mice by&#xD;
      special methods. This efficient drug sensitivity test can provide sensitivities of single&#xD;
      drug or drug combination in order to screen out the optimal individualized regimens for each&#xD;
      patient. The investigators intend to use the Second-generation sequencing（NGS）and MiniPDX&#xD;
      drug sensitivity models to guide the treatment decision-making for patients who were&#xD;
      resistant with abiraterone, enzalutamide or other new second-generation anti-androgenic&#xD;
      drugs. This project is to develop precise personalized treatment plans for patients and&#xD;
      extent their lifetimes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 28, 2019</start_date>
  <completion_date type="Anticipated">January 27, 2021</completion_date>
  <primary_completion_date type="Anticipated">January 27, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>ORR</measure>
    <time_frame>12 months</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PFS</measure>
    <time_frame>12 months</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>OS</measure>
    <time_frame>12 months</time_frame>
    <description>Overall survival is defined as time from initiation to death of any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ADR</measure>
    <time_frame>Up to 30 days of last study treatment.</time_frame>
    <description>Adverse Drug Reaction：Adverse events determined according to CTCAE (version 4.03) and attribution to study treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Consistency</measure>
    <time_frame>Up to 2 months of last study treatment.</time_frame>
    <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.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">15</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>MiniPDX Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients medication plan based on MiniPDX drug sensitivity test.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MiniPDX Group</intervention_name>
    <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.</description>
    <arm_group_label>MiniPDX Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient can provide detailed clinical baseline information including: name, age,&#xD;
             gender, pathology, past treatment, etc.;&#xD;
&#xD;
          2. Male, age ≥ 18 years old;&#xD;
&#xD;
          3. ECOG score 0~2 points;&#xD;
&#xD;
          4. Patient must be able to provide tissue samples for the drug sensitive test;&#xD;
&#xD;
          5. No treatment history with PI3K inhibitors, AKT inhibitors or mTOR inhibitors;&#xD;
&#xD;
          6. Estimated lifetime is ≥ 3 months;&#xD;
&#xD;
          7. Histological or cytologically determined prostate adenocarcinoma, excluding&#xD;
             neuroendocrine differentiation, signet ring cell carcinoma and small cell carcinoma;&#xD;
&#xD;
          8. Patient is at a castration level and the testosterone level is lower than &lt;50 ng/dL or&#xD;
             1.7 nmol/L;&#xD;
&#xD;
          9. Received abiraterone or enzalutamide and other new second-generation anti-androgenic&#xD;
             drugs and have disease progression. Disease progression is defined by PCWG3 :The&#xD;
             progression of disease in PCWG3 is defined as satisfying one of the following:&#xD;
             according to the increase in PSA levels, there must be three consecutive increases in&#xD;
             PSA at least one week apart, and the minimum value is greater than or equal to 5.0&#xD;
             ng/ml; disease progression as assessed by RECIST 1.1, considering PSA levels or not;&#xD;
             PCWG3 defines bone disease progression, which is bone scan found 2 or more new&#xD;
             lesions;&#xD;
&#xD;
         10. Evidence of distant metastatic disease (such as bone scans and CT/MRI results),&#xD;
             imaging data that can be used to assess the condition before and after treatment, or&#xD;
             imaging experience provided by three imaging hospitals with experience in three&#xD;
             hospitals. Test reports and oncology indicators include PSA values;&#xD;
&#xD;
         11. The patient can tolerate the primary physician to perform the puncture operation,&#xD;
             after receiving the informed consent from the patient and the family members;&#xD;
&#xD;
         12. The follow-up period must be at least greater than 2 months;&#xD;
&#xD;
         13. Be able to follow the research and follow-up procedures to provide real and effective&#xD;
             information;&#xD;
&#xD;
         14. The patient or his legal guardian understands the test procedure and content and&#xD;
             voluntarily signs the printed informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Cognitive ability and psychological abnormalities&#xD;
&#xD;
          2. ECOG score 3-4 points or blood biochemical examination indicates that the patient is&#xD;
             not suitable for continuing chemotherapy or chemotherapy has been postponed&#xD;
&#xD;
          3. Can not provide enough tumor puncture tissue, not enough tumor cells for subsequent&#xD;
             experiments;&#xD;
&#xD;
          4. Patient who is unwilling to receive follow-up treatment after the Mini PDX model drug&#xD;
             sensitivity test;&#xD;
&#xD;
          5. The investigator believes that the subject may not be able to complete the study or&#xD;
             may not be able to comply with the requirements of this study (for administrative&#xD;
             reasons or other reasons).&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Haitao Wang</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tianjin Medical University Second Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Haitao Wang, Ph.D</last_name>
    <phone>+86-022-88326385</phone>
    <email>peterrock2000@126.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Tianjin Medical University Second Hospital</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300211</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Haitao Wang</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <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.</citation>
    <PMID>30257718</PMID>
  </reference>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 24, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>November 25, 2019</last_update_submitted>
  <last_update_submitted_qc>November 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Prostate Cancer</keyword>
  <keyword>Patient Derived Xenograft</keyword>
  <keyword>CRPC</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03786848
org study id: MiniPDX-CRPC
nct id: NCT03786848
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: ORR
time frame: 12 months
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.
measure: PFS
time frame: 12 months
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.
measure: OS
time frame: 12 months
description: Overall survival is defined as time from initiation to death of any cause.
measure: ADR
time frame: Up to 30 days of last study treatment.
description: Adverse Drug Reaction：Adverse events determined according to CTCAE (version 4.03) and attribution to study treatment.
measure: Clinical Consistency
time frame: Up to 2 months of last study treatment.
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.
arm group label: MiniPDX Group
arm group type: Experimental
description: Patients medication plan based on MiniPDX drug sensitivity test.
intervention type: Other
intervention name: MiniPDX Group
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.
arm group label: MiniPDX Group
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Haitao Wang
role: Principal Investigator
affiliation: Tianjin Medical University Second Hospital
last name: Haitao Wang, Ph.D
phone: +86-022-88326385
email: peterrock2000@126.com
facility: 
status: Recruiting
contact: 
country: China
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.
PMID: 30257718
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
sharing ipd: No