Molecular Phenotype Changes and Personalized Treatment for CRPC

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

To explore the molecular phenotypic changes and personalized treatment in castration-resistant prostate cancer.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital
• Treatments: Cisplatin; Docetaxel; Etoposide; Etoposide phosphate; Prednisone

Criteria

Inclusion Criteria:

1. 18 Years and older;

2. patients with CRPC according to European Association of Urology diagnostic criteria ;

3. vital organs functions including bone marrow, heart, liver, kidney are normal;

4. 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 );

5. 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

6. 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.

7. 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 Criteria:

1. other cancers

2. cognitive inability and mental abnormalities

3. 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

4. can not tolerate chemotherapy or refuse chemotherapy

5. using the other test drug or participate other clinical trials

6. can not oral drugs

7. receiving chemotherapy, biological therapy, or other anti-cancer medicine intervals less than 4 weeks

8. Researchers believe patients unsuitable (compliance, we should not follow-up)