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Denosumab delays development of prostate cancer bone metastasis
Date:11/15/2011

432 participants at 319 centers in 30 countries all prostate cancer patients whose tumors had stopped responding to androgen-deprivation therapy and were metastasis-free, although rising PSA levels indicated they were at risk for metastasis.

Participants were randomly assigned to receive injections of either denosumab or a placebo every four weeks. During the two-year study period, patients were examined including a bone scan every four months, and X-ray skeletal surveys performed annually. If a bone scan indicated the presence of metastasis, it was confirmed with either X-ray, CT scan or MRI. After that confirmation, study treatment was discontinued, since other therapies are approved to treat metastatic prostate cancer.

Study results indicated that denosumab treatment increased bone-metastasis-free survival defined as the time to either the first metastasis or death from any cause by an average of more than four months, extended the time to first metastasis and delayed symptoms of metastasis. Biochemical markers indicated that denosumab treatment did reduce bone turnover. While there was no survival difference between the two study groups, the authors note that that fact that denosumab was discontinued when the first metastasis was diagnosed makes judging the drug's effects on survival difficult.


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Contact: Katie Marquedant
kmarquedant@partners.org
617-726-0337
Massachusetts General Hospital
Source:Eurekalert

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