Prostate Cancer Clinical Trial
— BRP30Official title:
Antibiotic Prophylaxis for HDR Brachytherapy in the Treatment of Prostate Cancer: a Phase III Randomized Trial
Verified date | March 2022 |
Source | CR-CSSS Champlain-Charles-Le Moyne |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Phase III study that aims to evaluate the necessity of prophylactic antibiotics use after HDR brachytherapy in the treatment of prostate adenocarcinomas.
Status | Suspended |
Enrollment | 255 |
Est. completion date | February 2023 |
Est. primary completion date | February 2023 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 85 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Hôpital Charles LeMoyne | Greenfield Park | Quebec |
Lead Sponsor | Collaborator |
---|---|
CR-CSSS Champlain-Charles-Le Moyne |
Canada,
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. — View Citation
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. Review. — View Citation
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. — View Citation
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. Review. — View Citation
Kovács G, Pötter 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. — View Citation
Puig J, Darnell A, Bermúdez P, Malet A, Serrate G, Baré M, Prats J. Transrectal ultrasound-guided prostate biopsy: is antibiotic prophylaxis necessary? Eur Radiol. 2006 Apr;16(4):939-43. Epub 2006 Jan 4. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Urinary toxicities | Urinary toxicities rate in each arm measured by the Common Terminology Criteria for Adverse Events (CTCAE) score. The following Medical Dictionary for Regulatory Activities (MedDRA) System Organ Classes (SOC) will be included: Renal and urinary disorders, and Infections and infestations. The CTCAE score ranges from grade 0 to 5, where higher grade represents higher toxicity. Each presented toxicity will be assessed and scored. Each toxicity will be evaluated by its percentage of incidence in the sample. Each patient will also be evaluated by his worse toxicity (higher grade). The percentage of toxicities incidence and their severity will be compared between groups. | 5 years | |
Secondary | IPSS score effects | Evaluate International Prostate Symptom Score (IPSS) effects of prophylactic antibiotics. The IPSS Score ranges from 0 to 35. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms. Mean scores will be compared between groups. | 5 years | |
Secondary | Serious infectious complications | Evaluate the rate of serious infectious complications post HDR brachytherapy | 5 years | |
Secondary | The risk of colitis due to C. difficile infection | To evaluate the risk of colitis due to C. difficile infection all patients with diarrhea or increased bowel movement (colitis symptoms) will be tested for C. difficile infection. The association between colitis and the presence of C. difficile infection will be evaluated by Chi-square in each group. | 12 weeks |
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