“The addition of hormonal therapy to radiation treatment following surgery significantly improved survival in patients with recurrent prostate cancer, according to the results of a study published in The New England Journal of Medicine.
“In the multicenter trial—which initially enrolled 760 men with biochemical recurrence after radical prostatectomy—patients were randomly assigned to treatment with bicalutamide or placebo for 2 years, along with 6.5 weeks of radiation therapy.”
“The FDA today approved Axumin, an injectable radioactive diagnostic agent used to detect recurrent prostate cancer.
“The agent is indicated for PET imaging in men who have suspected prostate cancer recurrence based on elevated PSA levels following treatment.
“The FDA based its decision on results of two studies that evaluated the safety and efficacy of Axumin (Blue Earth Diagnostics). One study compared 105 Axumin scans to histopathology obtained by prostate biopsy and by biopsies of suspicious imaged lesions in men suspected of having prostate cancer recurrence. In the second study, researchers evaluated 96 Axumin scans with C11 choline scans in patients with a median PSA of 1.44 ng/mL.”
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“A US Food and Drug Administration (FDA) advisory committee voted October 1 not to recommend approval, at least for now, of a high-intensity focused ultrasound (HIFU) device to treat some patients with recurrent prostate cancer.
“Members of the Gastroenterology and Urology Devices Panel of the FDA’s Medical Devices Advisory Committee encouraged the device manufacturer to continue to conduct research but to come back when the ongoing pivotal trial at 20 sites in the United States and Canada is completed, not halfway through.
“SonaCare Medical Devices of Charlotte, North Carolina, had requested FDA approval of its Sonablate 450, a computer-controlled device with a probe that clinicians can use to deliver HIFU energy through thermal ablation to the prostate. The proposed indication was for treatment of biopsy-proven recurrent cancer in patients, low to high risk, who have failed primary external beam radiation therapy and have prostate-specific antigen (PSA) readings lower than 10 ng/mL.
“SonaCare based its request on an interim analysis of results from a nonrandomized, single-group clinical trial involving the first 100 of a planned 200 patients. Patient ages ranged from 53 to 83 years (mean, 69.7 years), they were mostly white (76%), and they had pretreatment PSA readings ranging from 0.4 to 14 (mean, 4.9).
“Of the first 100 patients enrolled at 16 sites, 78 completed 12 months of follow-up and had a biopsy, and 22 did not.”
“Men who begin taking statins after prostate cancer surgery are less likely to have a recurrence of their cancer, according to a retrospective analysis led by researchers at Duke Medicine.
” ‘Our findings suggest that beginning statins after surgery may reduce the risk of prostate cancer recurrence, so it’s not too late to start statins after a diagnosis,’ said lead author Emma H. Allott, Ph.D., a postdoctoral associate in the Division of Urology at Duke and the Durham Veterans Affairs Medical Center.”
“In men with recurrent prostate cancer following radiation therapy, magnetic resonance imaging (MRI)-guided focal cryoablation is feasible and seems safe, according to a study published in the August issue of Radiology. Joyce G.R. Bomers, from Radboud University Nijmegen Medical Centre in the Netherlands, and colleagues, studied 10 consecutive patients with histopathologically proved recurrent prostate cancer after radiation therapy, without evidence of distant metastases. While patients were under general anesthesia, a urethral warmer was inserted, followed by transperineal insertion of cryoneedles during real-time MRI (magnetic resonance imaging) and insertion of a rectal warmer. MRI guidance was used to continuously monitor ice ball growth. Two cycles of freezing and thawing were conducted. Follow-up included a urologist visit, prostate-specific antigen level measurement, and multiparametric MRI at 3, 6, and 12 months.”