| General information |
| Database: | DB00225 |
| Objective: | Drug development and clinical decision making for patients with metastatic prostate cancer (PC) have been hindered by a lack of quantitative methods of assessing changes in bony disease burden that are associated with overall survival (OS). Bone scan index (BSI), a quantitative imaging biomarker of bone tumor burden, is prognostic in men with metastatic PC. they evaluated an automated method for BSI calculation for the association between BSI over time with clinical outcomes in a randomized doubleblind trial of tasquinimod (TASQ) in men with metastatic castrationresistant PC (mCRPC). |
| Authors: | Armstrong AJ, et al |
| Title: | Assessment of the bone scan index in a randomized placebocontrolled trial of tasquinimod in men with metastatic castrationresistant prostate cancer (mCRPC). |
| Journal: | Urol Oncol |
| Year: | 2014 |
| PMID: | 25240761 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | tasquinimod
|
| Target: | Calgranulin B
|
| Cancer Type: | prostate cancer |
| Cancer Subtype: | advanced castrationresistant prostate cancer |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | a randomized doubleblind trial |
| Key Patients Feature: | men with metastatic castrationresistant prostate cancer (mCRPC) |
| Biomarker: | Bone scan index (BSI) |
| Biomark Analysis: | a quantitative imaging biomarker of bone tumor burden, is prognostic in men with metastatic PC. |
| Control Group Info: | placebo |
| Treatment Info: | Bone scans collected during central review from the TASQ trial were analyzed retrospectively using EXINIbone(BSI), an automated software package for BSI calculation. |
| Primary End Point: | Associations between BSI and other prognostic biomarkers, progression free survival, OS, and treatment |
| Secondary End Point: | NA |
| Patients Number: | 201 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | TASQ delayed BSI progression. |
| Median PFS A vs. C: | BSI worsening at 12 weeks was prognostic for progression free survival (HR = 2.14 per BSI doubling, P<0.001) in multivariate analyses including baseline BSI and TASQ treatment. |
| Median OS A vs. C: | Baseline BSI correlated with prostatespecific antigen and alkaline phosphatase levels and was associated with OS in univariate (hazard ratio [HR] = 1.42, P = 0.013) and multivariate (HR = 1.64, P<0.001) analyses. BSI worsening at 12 weeks was prognostic for OS (HR = 1.58, P = 0.033) in multivariate analyses including baseline BSI and TASQ treatment. |
| Adverse Event(agent arm): | NA |
| Conclusions: | BSI and BSI changes over time were independently associated with OS in men with mCRPC. A delay in objective radiographic bone scan progression with TASQ is suggested; prospective evaluation of BSI progression and response criteria inphase 3 trials of men with mCRPC is warranted. |