Clinical trial · Interventional
Antibiotic Prophylaxis for HDR Brachytherapy in the Treatment of Prostate Cancer
Antibiotic Prophylaxis for HDR Brachytherapy in the Treatment of Prostate Cancer: a Phase III Randomized Trial
NCT03862170CI-TRIAL-00085891BRP30terminatedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Covid-19 pandemic
Summary
Brief summary (as posted)
Phase III study that aims to evaluate the necessity of prophylactic antibiotics use after HDR brachytherapy in the treatment of prostate adenocarcinomas.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cefazolin | Drug | — | UNRESOLVED |
| Ciprofloxacin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Ciprofloxacin
- description
- Patients in this arm will receive Ciprofloxacin 400mg IV 120mn (prophylactic antibiotic) before their HDR brachytherapy
- interventionNames
- Drug: Ciprofloxacin
- type
- EXPERIMENTAL
- label
- Cefazolin
- description
- Patients in this arm will receive Cefazolin 2000mg IV 60mn (prophylactic antibiotic) before their HDR brachytherapy
- interventionNames
- Drug: Cefazolin
- type
- NO_INTERVENTION
- label
- No prophylactic antibiotics
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * All patients eligible to brachytherapy for the treatment of prostate cancer * No history of serious urinary tract infection post prostate biopsy Exclusion Criteria: * Urosepsis post biopsy * Contraindication to brachytherapy
References
Publications (7)
- BACKGROUNDKovacs 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. PMID 15734201
- BACKGROUNDHoskin 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. PMID 23773409
- BACKGROUNDPuig 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. PMID 16391904
- BACKGROUNDGriffith 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. PMID 12187213
- BACKGROUNDYamada 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. PMID 22265435
- BACKGROUNDDeshpande 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. PMID 18067688
- BACKGROUNDChristiano 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.