Investigators seek a new therapeutic strategy for castrated resistant prostate cancer(CRPC) patients with PI3K-AKT-mTOR signaling pathway deficiency by next generation sequencing(NGS).
The prognosis of castrated resistant prostate cancer(CRPC) is very poor.Now,there is not an ideal therapeutic strategy.Further clarifying its mechanism and finding more effective therapeutic targets on this basis are the clinical problems to be solved urgently. More and more studies have confirmed that the role of PI3K-AKT-mTOR signaling pathway in the development of castration resistance to prostate cancer.By next generation sequencing of 115 patients with CRPC, investigators found that 22% of the patients had mutations in the PI3K-AKT-mTOR signaling related genes.Investigators found that 50% of the patients could benefit from the mTOR inhibitors.But the specific clinical significance and molecular mechanism are urgently needed to be elucidated. This project is based on the hypothesis that Everolimus can target CRPC patients with PI3K-AKT-mTOR signaling pathways deficiency.So,investigators intend to peform a prospective, randomized, controlled,multicenter clinical study to find potential therapeutic targets and treatment strategies for CRPC patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
Everolimus will be treated at a dose of 10mg/day orally once a day. One cycle of therapy consists of 28 days. The patients also receive the best supportive care.
Placebo will be treated at a dose of 10mg/day orally once a day. One cycle of therapy consists of 28 days. The patients also receive the best supportive care.
Tianjin First Center Hospital
Tianjin, Tianjin Municipality, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, China
Tianjin Medical Unversity Second Hospital
Tianjin, Tianjin Municipality, China
PFS
Progression free survival of All the Evaluable Participants.Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0).(Note: the appearance of one or more new lesions is also considered progression).
Time frame: 36 months
OS
Overall Survival of the Participants
Time frame: 36months
ORR
Objective Response Rate is defined as the proportion of patients with complete response(CR) or partial response(PR).
Time frame: 36 months
DCR
Disease control is defined as the proportion of patients who had a best response rating of complete response, partial response, or stable disease, and lasted at least 4 weeks.
Time frame: 36 months
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