Publications by authors named "Shawn Zimberg"
Purpose/objectives: Rectal spacers have been shown to reduce rectal side effects in patients receiving prostate radiation. However, concerns remain regarding precise and reproducible gel injection. We evaluated efficacy and safety of a novel rectoprostatic spacer balloon that allows potential for controlled, adaptable deployment.
View Article and Find Full Text PDFPurpose: A multicenter, double-arm, central core lab, retrospective study was performed to compare the rectal dosimetry of patients implanted with two injectable, biodegradable perirectal spacers, in conventional fractionation (CF), as well as ultrahypofractionation (UH) treatment plans.
Methods And Materials: Fifty-nine patients were enrolled into the study in five centers: two centers in Europe, which implanted a biodegradable balloon spacer in a total of 24 subjects and three centers in the US, which implanted the SpaceOAR in 35 subjects. Anonymized CTs (pre and post-implantation) were reviewed by the central core lab.
Purpose: Previously a phase III trial of a hydrogel rectal spacer during prostate radiation therapy found decreased toxicity and a clinically significant improvement in bowel quality of life (QOL) at 3 years by the Expanded Prostate Cancer Index. We performed a secondary analysis to identify men less likely to benefit.
Methods And Materials: Clinical and dosimetric data for the 222 patients enrolled on the SpaceOAR phase III trial were analyzed.
Background: We previously reported the results of a phase 3 trial evaluating a prostate/rectal hydrogel spacer during prostate intensity modulated radiation therapy, which resulted in decreased rectal dose and toxicity and less decline in bowel quality of life (QOL). A secondary analysis was performed to correlate penile bulb dose and sexual QOL.
Methods And Materials: Sexual QOL was measured with the Expanded Prostate Cancer Index Composite (EPIC) by mean scores, the proportion of patients with a minimal clinically important difference (MID), and analyses of the different items composing the sexual domain.
Purpose: Quality of life (QoL) outcomes play a major role in the treatment selection for prostate cancer (CaP). We evaluated the urinary QoL outcomes in men who were treated with image-guided intensity-modulated radiation therapy (IG-IMRT) for CaP.
Methods And Materials: We enrolled men who were diagnosed with CaP and underwent IG-IMRT in a large urological group practice into a prospectively maintained database.
Purpose: SpaceOAR, a Food and Drug Administration-approved hydrogel intended to create a rectal-prostate space, was evaluated in a single-blind phase III trial of image guided intensity modulated radiation therapy. A total of 222 men were randomized 2:1 to the spacer or control group and received 79.2 Gy in 1.
View Article and Find Full Text PDFPurpose: Perirectal spacing, whereby biomaterials are placed between the prostate and rectum, shows promise in reducing rectal dose during prostate cancer radiation therapy. A prospective multicenter randomized controlled pivotal trial was performed to assess outcomes following absorbable spacer (SpaceOAR system) implantation.
Methods And Materials: Overall, 222 patients with clinical stage T1 or T2 prostate cancer underwent computed tomography (CT) and magnetic resonance imaging (MRI) scans for treatment planning, followed with fiducial marker placement, and were randomized to receive spacer injection or no injection (control).
Purpose: We determined therapeutic trends in the management of adenocarcinoma of the prostate, and in the case of intensity modulated radiation therapy we investigated whether site of service influenced those trends.
Materials And Methods: A variety of CPT codes to treat adenocarcinoma of the prostate were extracted from the Medicare Part B 5% sample for the years 2006 to 2008 inclusive. Data were stratified by year, type of service and, in the case of radiation therapy, site of service.