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Personalized Mini-PDX for Metastatic CRPC

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ClinicalTrials.gov Identifier: NCT03786848
Recruitment Status : Recruiting
First Posted : December 25, 2018
Last Update Posted : April 23, 2019
Sponsor:
Information provided by (Responsible Party):
Tianjin Medical University Second Hospital

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Other: MiniPDX Group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. OS [ Time Frame: 12 months ]
    Overall survival is defined as time from initiation to death of any cause.

  3. 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.

  4. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03786848


Contacts
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Contact: Haitao Wang, Ph.D +86-022-88326385 peterrock2000@126.com

Locations
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China, Tianjin
Tianjin Medical University Second Hospital Recruiting
Tianjin, Tianjin, China, 300211
Contact: Haitao Wang         
Sponsors and Collaborators
Tianjin Medical University Second Hospital
Investigators
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Principal Investigator: Haitao Wang Tianjin Medical University Second Hospital

Publications:
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Responsible Party: Tianjin Medical University Second Hospital
ClinicalTrials.gov Identifier: NCT03786848     History of Changes
Other Study ID Numbers: MiniPDX-CRPC
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tianjin Medical University Second Hospital:
Prostate Cancer
Patient Derived Xenograft
CRPC

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases