Can prostate biopsies be safely done without antibiotics? A study on infection risks after a common procedure in the Philippines
| ISRCTN | ISRCTN17045111 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17045111 |
- Submission date
- 04/06/2025
- Registration date
- 28/06/2025
- Last edited
- 28/08/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
Antibiotic resistance is a growing global health problem. It happens when bacteria and other germs become resistant to the medicines used to treat infections. This can lead to longer illnesses, more serious health problems, and fewer treatment options.
Prostate cancer is the most common cancer in men worldwide. To diagnose it, doctors often need to take a small sample of the prostate, called a biopsy. Traditionally, this is done through the rectum, which carries a risk of infection—even when antibiotics are used.
A newer method, called a transperineal biopsy, goes through the skin between the anus and scrotum instead of the rectum. This method is cleaner and may not need antibiotics at all. This study aims to find out if it’s safe to skip antibiotics when using this newer method, which could help reduce unnecessary antibiotic use and fight resistance.
Who can participate?
Men aged 40 to 75 who are scheduled for a transperineal prostate biopsy may be eligible. Participants must be generally healthy, have no signs of infection, and meet other medical criteria.
What does the study involve?
Participants will be randomly assigned to one of two groups: one will receive antibiotics before the biopsy, and the other will not. All participants will be monitored for 30 days after the procedure to check for any infections or other complications.
What are the possible benefits and risks of participating?
There are no direct health benefits for participants. However, those who do not receive antibiotics may avoid side effects from these drugs.
The main risk is infection, which is already a known risk of prostate biopsy. Studies suggest that the risk is low and not increased by skipping antibiotics in this type of biopsy.
Where is the study run from?
St. Luke's Medical Center (Philippines).
When is the study starting and how long is it expected to run for?
January 2024 to July 2025.
Who is funding the study?
St. Luke's Medical Center (Philippines).
Who is the main contact?
Dr Joseph Vincent M. Songco, jvmsongco@gmail.com
Contact information
Public, Scientific, Principal Investigator
308 Dingalan St. Ayala Alabang Village
Muntinlupa City
1780
Philippines
 ORCID ID |
0009-0001-1691-8241 |
|---|---|
| Phone | +63 9178122923 |
| jvmsongco@stlukes.com.ph |
Study information
| Study design | 2 center interventional double blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Safety |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Post procedural infections in antibiotic prophylaxis-free transperineal prostate biopsy: a double blinded randomized controlled clinical trial, a 2 center experience in the Philippines |
| Study objectives | Omitting prophylactic antibiotics is non inferior to giving prophylactic antibiotics in terms of infection rate in transperineal prostate biopsies |
| Ethics approval(s) |
Approved 05/06/2024, St. Luke's Medical Center Institutional Ethics Review Committee (279 E. Rodriguez Sr. Ave., Quezon City, 1112, Philippines; +63 28-723-0101 ext. 7391; ethicsreview@stlukes.com.ph), ref: SL-23295 |
| Health condition(s) or problem(s) studied | Urinary tract infection |
| Intervention | Participants were assigned in a 1:1 ratio to either no prophylaxis (Group A) or prophylaxis with 1 g intravenous cefoxitin (Group B). Randomization was based on a pre-generated sequential list from random.org and maintained by a research assistant not involved in patient care or outcome assessment. Allocation remained concealed from both the primary investigator and the participants. In Group A, no prophylactic antibiotics will be given, For Group B, a single 1 g dose of Intravenous Cefoxitin will be administered 1 hour prior to the procedure. All subjects underwent general laryngeal mask anesthesia. Upon induction, Excess hair in the perineal area was clipped. The perineum was prepped with 10% povidone iodine (Betadine), applied in accordance with institutional protocol. MRI/ultrasound fusion-guided prostate biopsy was performed using the Koelis system. Both targeted and systematic cores were obtained in all participants under sterile conditions. Final Histopathology results will be collected. Patients will be followed for 30 days post procedure. An initial assessment is done at 7 days using a symptom checklist for signs and symptoms of infection. Patients will also be asked to have a urine culture submitted. After the initial assessment, patient’s who present with signs of infection will undergo further assessment, including clinical evaluation, and will be treated accordingly. Type of infection and treatment will be documented.. Lower urinary tract symptoms (e.g., dysuria, frequency, hematuria) that were transient, mild, and self-limiting were not classified as postoperative infections. Decisions to treat were guided by symptom severity and the presence of fever. Decision to admit patient for hospitalization will depend on the assessment of the primary investigator along with the attending Urologist. Patients who developed symptoms were followed until full resolution. Patients who do not present with signs of infection will be followed for 30 days and will be asked to report symptoms of such. All infection occurring beyond 7 days, emergency room consults, hospital admissions, and non-infectious complications will be recorded. |
| Intervention type | Other |
| Primary outcome measure | Incidence of Urinary Tract Infection or Sepsis within 30 days post biopsy. This will be measured through a symptom check list including symptoms of Fever, hematuria, dysuria, suprapubic pain, perineal pain, or foul smelling urine, with bacteria identified on urine culture. Sepsis is defined using the Sepsis 2 definition of confirmed infection through urine culture accompanied by at least two of the following: A body temperature above 38°C (100.4°F) or below 36°C (96.8°F), A heart rate greater than 90 beats per minute, A respiratory rate greater than 20 breaths per minute, or a PaCO2 less than 32 mmHg, A white blood cell count greater than 12,000 cells/µL, less than 4,000 cells/µL, or more than 10% immature (band) forms. |
| Secondary outcome measures | 1. 30 day readmission rates measured using patient records 2. Overall 30 day complication rates measured by Clavien Dino scoring |
| Overall study start date | 05/01/2024 |
| Completion date | 01/07/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 40 Years |
| Upper age limit | 75 Years |
| Sex | Male |
| Target number of participants | 136 |
| Total final enrolment | 140 |
| Key inclusion criteria | 1. Age 40-75 years 2. American Society of Anesthesiologists score of I or II 3. Those undergoing Transperineal Prostate Biopsy 4. Urine Culture Negative Patients 5. Non Tender Prostate on DRE 6. Asymptomatic Patients 7. Charlson Score <5 |
| Key exclusion criteria | 1. Acute prostatitis within the last 6 months. 2. History of documented Urinary Tract Infection (UTI), or symptoms of UTI (painful micturition, Frequency, Urgence, suprapubic or flank pain, cloudy and foul-smelling urine) for the past 6 months. 3. Tender and boggy prostate on initial DRE 4. With ongoing antibiotics treatment for the past month 5. History of antibiotic allergy 6. Prior definitive therapy for prostate cancer, such as radiation therapy or partial gland ablation. 7. Those with uncontrolled diabetes mellitus, immunocompromised or immunosuppressed status. 8. Those with other pre-existing urinary tract conditions such as Benign Prostatic Hyperplasia in retention, Urinary retention from neurogenic causes, and those with indwelling stents or urethral catheters 9. Those with Prosthetic Heart Valves 10. Patients with ongoing infection elsewhere 11. Patients with Bleeding Disorders 12. Patients with Asymptomatic Bacteriuria |
| Date of first enrolment | 04/06/2024 |
| Date of final enrolment | 01/07/2025 |
Locations
Countries of recruitment
- Philippines
Study participating centres
Quezon City
1112
Philippines
Taguig City
1634
Philippines
Sponsor information
Hospital/treatment centre
279 E. Rodriguez Sr. Ave.
Quezon City
1112
Philippines
| Phone | +63 28-723-0101 ext. 7391 |
|---|---|
| ethicsreview@stlukes.com.ph | |
| Website | http://www.stluke.com.ph/ |
"ROR" |
https://ror.org/02h4kdd20 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/09/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a peer reviewed journal |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be published as a supplement to the results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 28/08/2025 | No | No | ||
| Protocol file | version 6 | 07/01/2025 | 28/08/2025 | No | No |
| Statistical Analysis Plan | version 2.0 | 15/01/2025 | 28/08/2025 | No | No |
Additional files
Editorial Notes
28/08/2025: The following changes were made to the trial record:
1. Protocol file uploaded.
2. The statistical analysis plan was uploaded as an additional file.
3. The basic results have been uploaded as an additional file.
25/06/2025: Trial's existence confirmed by St. Luke's Medical Center Institutional Ethics Review Committee.
