NCT03580239

Everolimus in Castrated Resistant Prostate Cancer(CRPC)Patients With PI3K-AKT-mTOR Signaling Pathway Deficiency

Placebo-Controlled, Randomized, Prospective and Multicenter Trial of Everolimus in Castrated Resistant Prostate Cancer Patients With PI3K-AKT-mTOR Signaling Pathway Deficiency

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Tianjin Medical University Second Hospital · Academic / Other
• Sex: Male
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Everolimus	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.
DRUG	Placebo	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.

Timeline

• Start date: 2019-01-01
• Primary completion: 2023-01-31
• Completion: 2023-12-01
• First posted: 2018-07-09
• Last updated: 2018-07-09

Locations

4 sites across 1 country: China

Regulatory

• FDA-regulated drug study