| General information |
| Database: | DB00234 |
| Objective: | The phosphatase and tensin homolog (PTEN) tumor suppressor gene is deregulated in many advanced prostate cancers, leading to activation of the phosphatidylinositol 3kinase (PI3K)Aktmammalian target of rapamycin (mTOR) pathway and thus increased cell survival. |
| Authors: | Templeton AJ, et al |
| Title: | Phase 2 trial of singleagent everolimus in chemotherapynaive patients with castrationresistant prostate cancer (SAKK 08/08). |
| Journal: | Eur Urol |
| Year: | 2013 |
| PMID: | 23582881 |
| Trial Design |
| Clinical Trial Id: | NCT00976755 |
| Agent: | everolimus
|
| Target: | mammalian target of rapamycin (mTOR)
|
| Cancer Type: | prostate cancer |
| Cancer Subtype: | advanced castrationresistant prostate cancer |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | A singlearmphase II trial |
| Key Patients Feature: | chemotherapynaive patients with castrationresistant prostate cancer |
| Biomarker: | PSA; Deletion of PTEN |
| Biomark Analysis: | higher serum levels of carboxypeptidase M and apolipoprotein B were predictive for reaching the primary end point.Deletion of PTEN was associated with longer PFS and response. |
| Control Group Info: | single arm |
| Treatment Info: | Everolimus was administered continuously at a dose of 10mg daily. |
| Primary End Point: | progression free survival (PFS), radiographic progression, or clinical progression. |
| Secondary End Point: | NA |
| Patients Number: | 37 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | A total of 13 patients (35%; 95% confidence interval, 2053) met the primary end point. Confirmed PSA response more than and equal to 50% was seen in two (5%), and four further patients (11%) had a PSA decline more than and equal to 30%. |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | Deletion of PTEN was associated with longer PFS |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | NA |
| Conclusions: | Everolimus activity in unselected patients with mCRPC is moderate, but PTEN deletion could be predictive for response. Several serum glycoproteins were able to predict PFS at 12 wk. Prospective validation of these potential biomarkers is warranted. |