Entry Detail
| General information | |
| Database: | DB00213 |
| Objective: | systemic treatment options for patients with hormonerefractory prostate cancer (HRPC) that progress despite the use of Docetaxel are very limited. One of the options of compassionate use currently available is the use of Sunitinib. They present a joint preliminary experience with the use of Sunitinib in this clinical case. |
| Authors: | Gasent JM |
| Title: | [Experience with sunitinib in hormoneresistant metastatic prostate cancer that is unresponsive to docetaxel]. |
| Journal: | Actas Urol Esp |
| Year: | 2011 |
| PMID: | 21256396 |
| Trial Design | |
| Clinical Trial Id: | NA |
| Agent: | sunitinib |
| Target: | FL cytokine receptor Mast/stem cell growth factor receptor Vascular endothelial growth factor receptor 2 Plateletderived growth factor receptor |
| Cancer Type: | prostate cancer |
| Cancer Subtype: | castrationresistant prostate cancer |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | a case series data collection |
| Key Patients Feature: | patients with hormonerefractory metastatic and progressive prostate cancer, previously treated with at least a regime of Docetaxelbased chemotherapy |
| Biomarker: | PSA |
| Biomark Analysis: | Serum prostatespecific antigen levels were prospectively monitored as a biomarker for cancer activity. |
| Control Group Info: | single arm |
| Treatment Info: | They administered a dosage of 50mg/day for fourweek cycles, follotheyd by a twoweek rest per cycle, until they reached a total of eight cycles or up to clinical progression or intolerable toxicity. |
| Primary End Point: | the PSA response rate |
| Secondary End Point: | the progression free period. |
| Patients Number: | 8 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | in four cases, the PSA dropped to below 50% of the baseline level at the beginning of the treatment, and five patients presented some decrease in PSA. |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 16.4 weeks |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | Toxicity arising from the treatment was moderate and manageable. |
| Conclusions: | despite the limits of this experience, they can say that Sunitinib appears to be an active and safe option in patients with hormonerefractory prostate cancer that is resistant to chemotherapy with Docetaxel. |