Status:
UNKNOWN
Molecular Phenotype Changes and Personalized Treatment for CRPC
Lead Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Conditions:
Hormone Refractory Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
To explore the molecular phenotypic changes and personalized treatment in castration-resistant prostate cancer.
Detailed Description
This is a multi-center study to explore the molecular phenotypic changes in castration-resistant prostate cancer by histopathological,immunohistochemical and molecular analysis of cancer related genes...
Eligibility Criteria
Inclusion
- 18 Years and older;
- patients with CRPC according to European Association of Urology diagnostic criteria ;
- vital organs functions including bone marrow, heart, liver, kidney are normal;
- complete pathological specimens including newly diagnosed with prostate cancer and disease progress to CRPC: ① biopsies or surgical specimens (tissue bank or wax block preserved specimens) at diagnosis ; ② re-biopsy specimens,transurethral prostatectomy (TURP) specimens, metastases palliative surgical specimens (tissue bank or wax block preserved specimens) after progress to CRPC; ③ amount sufficient sample for DNA extraction and quality control by up to standard (a) Sample type: None RNA degradation and pollution-free DNA samples; (b) the amount of the sample (single): ≥ 250ng (using agilent liquid platform); (c) sample concentration: ≥ 50 ng / μl (using agilent liquid platform); (d) sample purity: OD 260/280 = 1.8 \~ 2.0 );
- Then we perform following tests when patients meet the above criteria: ①Histological analysis: Hematoxylin-eosin(HE) staining ②immunohistochemistry(IHC) staining ③ 48 carcinomas associated exon sequencing
- After performing the above test, enter treatment group ① Docetaxel \& Prednisone(DP) : with high PSA and no gene mutation; ② DP + targeted drugs: with high PSA and gene mutations; ③ cisplatin \& Etoposide(EP) : low PSA and no gene mutation; ④ EP + targeted drug: Low PSA and gene mutations.
- All patients enrolled in draw peripheral blood samples 7.5ml and detect circulating tumor cells (CTC) , monitoring efficacy.
- 8\. Willing and able to comply with the program during the study period. 9 before entering clinical trials to provide written informed consent form, and the patient has to know you can withdraw from the study at any time in the study, and without any loss.
- 10\. Agrees to provide blood and tissue specimens. 11 expected survival of\> 6 months 12.Karnofsky performance status (KPS)\> 60; Eastern Cooperative Oncology Group(ECOG) score 0-2 13 signed informed consent form
Exclusion
- other cancers
- cognitive inability and mental abnormalities
- other serious disease or condition
- severe, uncontrolled internal medicine and infectious diseases
- severe digestive disorder can not control
- severe electrolyte imbalance
- active disseminated intravascular coagulation
- major organ failure, such as decompensated heart, lung, liver, kidney failure
- peripheral neuropathy symptoms, NCI grade\> Ⅱ degree
- can not tolerate chemotherapy or refuse chemotherapy
- using the other test drug or participate other clinical trials
- can not oral drugs
- receiving chemotherapy, biological therapy, or other anti-cancer medicine intervals less than 4 weeks
- Researchers believe patients unsuitable (compliance, we should not follow-up)
Key Trial Info
Start Date :
June 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2016
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT02208583
Start Date
June 1 2014
End Date
December 1 2016
Last Update
August 5 2014
Active Locations (1)
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1
Department of Interventional Oncology, Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China, 300060