In April of 2010, the Food and Drug Administration (FDA) approved the first immunotherapy for prostate cancer. Sipuleucel-T (Provenge), an autologous active cellular immunotherapy (a cancer vaccine), was approved for men with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC). Sipuleucel-T was also the first active cellular immunotherapy approved by the FDA and, at the time of approval, only the second approved drug for mCRPC patients. Prior to approval, the only other option for these patients was the chemotherapy docetaxel. Continue reading…
Radium Ra 223 Dichloride will be considered as a treatment for patients who have castration-resistant prostate cancer with bone metastases under the FDA’s priority review program. The filing is based on the 922 patient phase III ALSYMPCA trial, of radium-223 plus current standard of care, or placebo plus current standard of care.
Choyke, PL. ASCO Genitourinary Symposium 2013. Feb. 14, 2012.
The recent approval by the U.S. Food and Drug Administration (FDA) for the production of C-11 choline at Mayo Clinic for PET imaging in patients with biochemical recurrence (BCR) of prostate cancer has generated intense interest in the biomedical molecular imaging community. The main reason for this enthusiasm is that this is the first approval of a PET agent specifically for detecting sites of recurrence in prostate cancer, a highly prevalent disease for which conventional imaging tools have proven inadequate.
A phase III study evaluated two osteoporosis drugs, denosumab and zoledronic acid, for the treatment of skeletal problems in patients with bone metastases in castration-resistant prostate cancer (CRPC). The average time to first bone-related adverse event was 20.7 months with denosumab and 17.1 months with zoledronic acid, suggesting that denosumab was more effective in this group.
New findings from two prostate cancer trials will be presented at the American Society of Clinical Oncology Annual Meeting. One trial determined that men with advanced prostate cancer who receive intermittent hormone therapy survive an average of 5.1 years compared to 5.8 years for men who receive therapy continuously. The second trial determined that abiraterone (Zytiga) in combination with prednisone (a steroid) was effective for the treatment of castration-resistant prostate cancer (CRPC) in patients who have not yet received chemotherapy. Abiraterone is currently approved for patients who have not responded to chemotherapy.
Results of a clinical trial that evaluated the prostate cancer vaccine Provenge have come under scrutiny. Questions arise regarding the reported 4-month survival benefit that ultimately led to FDA approval. Disputers suggest that a flaw in methods led to the survival benefit, but that the vaccine may actually cause harm.
A recent study evaluated the effects of finasteride (sold as Proscar) on the usefulness of prostate-specific antigen (PSA) screening to detect prostate cancer. Researchers determined that treatment with finasteride may differentiate individuals who have a rise in PSA due to cancer from those who have a rise due to other causes, such as benign enlargement and inflammation. The combination of finasteride with PSA to detect prostate cancer may decrease the rate of unnecessary biopsies.
A recent study evaluated the usefulness of surgery versus observation to treat localized prostate cancer. In the study, 731 men were followed for 10 years. Those treated with surgery did not have a significant decreased risk of death compared to those who were observed for advancing cancer.