drugset / Trial / NCT03356444

Docetaxel Versus Abiraterone as First-line Treatment in mCRPC Patients With Intraductal Carcinoma of the Prostate

NCT03356444 ↗

Phase 2 Unknown 140 enrolled West China Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2017-11
Primary completion
2020-12
Completion
2020-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Abiraterone acetate Small molecule 1000 mg Oral
Comparator Docetaxel Small molecule 75 mg/m2 Intravenous
Background Prednisone Other / unclassified 5 mg Oral
Background Prednisone Other / unclassified 10 mg Oral