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Metastatic castration-resistant Prostate cancer (mCRPC) is a very late stage of prostate cancer with poor prognosis. Although there are several treatment strategies available for mCRPC, these drugs are not always effective for every patient. Also, it's still not clear what's the best therapeutic choice for a certain group of patients.
In the previous works of the investigators, a subtype of prostate cancer, intraductal carcinoma of the prostate (IDC-P) was studied. The investigators have reported in their two published papers that, IDC-P is an adverse pathological type associated with rapid disease progression. They also found in another study that, for patients with IDC-P, Abiraterone seemed to have better treatment efficacy than Docetaxel-based chemotherapy as first-line treatment for mCRPC, in terms of either PSA-response and PSA-progression free survival. So, in this study, the investigators hope to design a prospective study to verify the predictive ability of IDC-P in the first-line treatment of mCRPC.
With disease progression, the drug resistance will inevitably occur in all patients after the treatment of CRPC. However, the exact mechanism of this process is not yet known. So, in this study the investigators are also trying to explore some of the genes related to the treatment efficacy by means of the next generation sequencing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abiraterone group | Experimental | Abiraterone acetate is administered in this arm. |
|
| Docetaxel group | Active Comparator | Docetaxel is administered in this arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abiraterone Acetate | Drug | Abiraterone Acetate: orally, 1000mg, qd, plus with prednisone orally, 5mg, bid. Course of treatment: Stop the treatment until biochemical, clinical or radiographic progression occurs. |
| Measure | Description | Time Frame |
|---|---|---|
| PSA-Progression free survival (PSA-PFS) | PSA progression was defined as an increase in the PSA level of 25% or more above the nadir (and by ≥ 2 ng/ml), with confirmation of 4 or more weeks later. | Up to 40 months |
| Radiographic progression free survival (rPFS) | rPFS was defined 1) according to the Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 criteria; or 2) as at least two new lesions on first post-treatment bone scan, with at least two additional lesions on the next bone scan. | Up to 40 months |
| Measure | Description | Time Frame |
|---|---|---|
| PSA response rate | PSA response is defined as ≥ 50% decline in PSA level from baseline, maintained for≥ 4 weeks | Up to 40 months |
| Overall survival (OS) | OS was defined as the duration from the initiation of treatment to death of any cause |
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Inclusion Criteria:
Exclusion Criteria:
Only male patient can enter this study
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000069501 | Abiraterone Acetate |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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The administration methods of the two groups are different, therefore, the investigators decide not to use masking.
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| Docetaxel | Drug | Docetaxel: intravenously, 75 mg/m^2, over 1 h every 3 weeks, plus with prednisone, orally, 10 mg, qd. Course of treatment: Stop the treatment until biochemical, clinical or radiographic progression occurs. If no progression, stop until 10 cycles of traetment |
|
| Up to 40 months |
| Eastern Cooperative Oncology Group (ECOG) score | 0 - Fully active, able to carry on all pre-disease performance without restriction;
| Up to 40 months |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D011083 |
| Polycyclic Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |