Antibiotic Prophylaxis for HDR Brachytherapy in the Treatment of Prostate Cancer

NCT03862170 | Terminated Phase 3

• 1 other identifier: AA-HCLM-14-033
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

Brief Summary

Phase III study that aims to evaluate the necessity of prophylactic antibiotics use after HDR brachytherapy in the treatment of prostate adenocarcinomas.

Conditions

Prostate Cancer

Keywords

HDR Brachytherapy; prophylactic antibiotics; ciprofloxacin; ancef; RCT

Outcome Measures

Primary Outcomes (1)

• Symptomatic urinary infections post HDR brachytherapy

  The rate of symptomatic urinary infections post HDR brachytherapy.

  from treatment up to 6 months, divided into acute (up to 3 months post treatment) and late (between 3 and 6 months post treatment)

Secondary Outcomes (4)

• Urinary toxicities

  5 years

• IPSS score effects

  5 years

• Serious infectious complications

  5 years

• The risk of colitis due to C. difficile infection

  12 weeks

Study Arms (3)

Ciprofloxacin

ACTIVE COMPARATOR

Patients in this arm will receive Ciprofloxacin 400mg IV 120mn (prophylactic antibiotic) before their HDR brachytherapy

Drug: Ciprofloxacin

Cefazolin

EXPERIMENTAL

Patients in this arm will receive Cefazolin 2000mg IV 60mn (prophylactic antibiotic) before their HDR brachytherapy

Drug: Cefazolin

No prophylactic antibiotics

NO INTERVENTION

Patients in this arm will not receive any prophylactic antibiotics before their HDR brachytherapy

Interventions

Ciprofloxacin DRUG

Ciprofloxacin 400 mg IV 120mn before HDR brachytherapy

Also known as: Ciloxan, Cipro, Neofloxin

Ciprofloxacin

Cefazolin DRUG

Also known as: Ancef, cefazoline, cephazolin, Cefacidal

Cefazolin

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients eligible to brachytherapy for the treatment of prostate cancer
• No history of serious urinary tract infection post prostate biopsy

You may not qualify if:

• Urosepsis post biopsy
• Contraindication to brachytherapy

Sponsors & Collaborators

• CR-CSSS Champlain-Charles-Le Moyne: lead

Study Sites (1)

Hôpital Charles LeMoyne

Greenfield Park, Quebec, J4V 2H1, Canada

Location

Related Publications (7)

• 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.

  PMID: 15734201 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.

  PMID: 23773409 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.

  PMID: 16391904 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.

  PMID: 12187213 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.

  PMID: 22265435 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.

  PMID: 18067688 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.

  PMID: 10688075 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Ciprofloxacin; Cefazolin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds

Study Officials

• Marjory Jolicoeur, MD,MSc

  CSSS Champlain-Charles-Le Moyne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD, PhD

Study Record Dates

• First Submitted: June 28, 2018
• First Posted: March 5, 2019
• Study Start: February 10, 2015
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2023
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)