drugset / Trial / NCT03862170
Antibiotic Prophylaxis for HDR Brachytherapy in the Treatment of Prostate Cancer
RandomizedParallel-groupOpen-labelPrevention
Summary
Phase III study that aims to evaluate the necessity of prophylactic antibiotics use after HDR brachytherapy in the treatment of prostate adenocarcinomas.
Timeline
- Start
- 2015-02-10
- Primary completion
- 2020-02
- Completion
- 2023-02
Publications
- Background Kovacs G, Potter R, Loch T, Hammer J, Kolkman-Deurloo IK, de la Rosette JJ, Bertermann H. GEC/ESTRO-EAU recommendations on temporary brachytherapy using stepping sources for localised prostate cancer. Radiother Oncol. 2005 Feb;74(2):137-48. doi: 10.1016/j.radonc.2004.09.004.
- Background Hoskin PJ, Colombo A, Henry A, Niehoff P, Paulsen Hellebust T, Siebert FA, Kovacs G. GEC/ESTRO recommendations on high dose rate afterloading brachytherapy for localised prostate cancer: an update. Radiother Oncol. 2013 Jun;107(3):325-32. doi: 10.1016/j.radonc.2013.05.002. Epub 2013 Jun 14.
- Background Puig J, Darnell A, Bermudez P, Malet A, Serrate G, Bare M, Prats J. Transrectal ultrasound-guided prostate biopsy: is antibiotic prophylaxis necessary? Eur Radiol. 2006 Apr;16(4):939-43. doi: 10.1007/s00330-005-0076-2. Epub 2006 Jan 4.
- Background Griffith BC, Morey AF, Ali-Khan MM, Canby-Hagino E, Foley JP, Rozanski TA. Single dose levofloxacin prophylaxis for prostate biopsy in patients at low risk. J Urol. 2002 Sep;168(3):1021-3. doi: 10.1016/S0022-5347(05)64565-X.
- Background Yamada Y, Rogers L, Demanes DJ, Morton G, Prestidge BR, Pouliot J, Cohen GN, Zaider M, Ghilezan M, Hsu IC; American Brachytherapy Society. American Brachytherapy Society consensus guidelines for high-dose-rate prostate brachytherapy. Brachytherapy. 2012 Jan-Feb;11(1):20-32. doi: 10.1016/j.brachy.2011.09.008.
- Background Deshpande A, Pant C, Jain A, Fraser TG, Rolston DD. Do fluoroquinolones predispose patients to Clostridium difficile associated disease? A review of the evidence. Curr Med Res Opin. 2008 Feb;24(2):329-33. doi: 10.1185/030079908x253735.
- Background Christiano AP, Hollowell CM, Kim H, Kim J, Patel R, Bales GT, Gerber GS. Double-blind randomized comparison of single-dose ciprofloxacin versus intravenous cefazolin in patients undergoing outpatient endourologic surgery. Urology. 2000 Feb;55(2):182-5. doi: 10.1016/s0090-4295(99)00412-4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cefazolin | Small molecule | 2000 mg | Intravenous |
| Comparator | Ciprofloxacin | Small molecule | 400 mg | Intravenous |