Personalized Mini-PDX for Metastatic CRPC

NCT03786848 | Unknown

• 1 other identifier: MiniPDX-CRPC
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Patient Derived Xenograft; CRPC

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (4)

• PFS

  12 months

• OS

  12 months

• ADR

  Up to 30 days of last study treatment.

• Clinical Consistency

  Up to 2 months of last study treatment.

Study Arms (1)

MiniPDX Group

EXPERIMENTAL

Patients medication plan based on MiniPDX drug sensitivity test.

Other: MiniPDX Group

Interventions

MiniPDX Group OTHER

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.

MiniPDX Group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Tianjin Medical University Second Hospital: lead

Study Sites (1)

Tianjin Medical University Second Hospital

Tianjin, Tianjin Municipality, 300211, China

RECRUITING

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Haitao Wang

  Tianjin Medical University Second Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haitao Wang, Ph.D

CONTACT

+86-022-88326385; peterrock2000@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2018
• First Posted: December 26, 2018
• Study Start: January 28, 2019
• Primary Completion: January 27, 2020
• Study Completion: January 27, 2021
• Last Updated: November 26, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)