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
25/06/2025
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

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

Dr Joseph Vincent Songco
Public, Scientific, Principal Investigator

308 Dingalan St. Ayala Alabang Village
Muntinlupa City
1780
Philippines

ORCiD logoORCID ID 0009-0001-1691-8241
Phone +63 9178122923
Email jvmsongco@stlukes.com.ph

Study information

Study design2 center interventional double blinded randomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeSafety
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titlePost procedural infections in antibiotic prophylaxis-free transperineal prostate biopsy: a double blinded randomized controlled clinical trial, a 2 center experience in the Philippines
Study objectivesOmitting 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) studiedUrinary tract infection
InterventionParticipants 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 typeOther
Primary outcome measureIncidence 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 measures1. 30 day readmission rates measured using patient records
2. Overall 30 day complication rates measured by Clavien Dino scoring
Overall study start date05/01/2024
Completion date01/07/2025

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit40 Years
Upper age limit75 Years
SexMale
Target number of participants136
Total final enrolment140
Key inclusion criteria1. 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 criteria1. 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 enrolment04/06/2024
Date of final enrolment01/07/2025

Locations

Countries of recruitment

  • Philippines

Study participating centres

St. Luke's Medical Center
279 E. Rodriguez Sr. Ave.
Quezon City
1112
Philippines
St. Luke's Medical Center Global City
Rizal Drive cor. 32nd St. 5th Ave
Taguig City
1634
Philippines

Sponsor information

St. Luke's Medical Center
Hospital/treatment centre

279 E. Rodriguez Sr. Ave.
Quezon City
1112
Philippines

Phone +63 28-723-0101 ext. 7391
Email ethicsreview@stlukes.com.ph
Website http://www.stluke.com.ph/
ROR logo "ROR" https://ror.org/02h4kdd20

Funders

Funder type

Hospital/treatment centre

St. Luke's Medical Center

No information available

Results and Publications

Intention to publish date01/09/2025
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryPublished as a supplement to the results publication
Publication and dissemination planPlanned publication in a peer reviewed journal
IPD sharing planThe datasets generated and/or analysed during the current study will be published as a supplement to the results publication

Editorial Notes

25/06/2025: Trial's existence confirmed by St. Luke's Medical Center Institutional Ethics Review Committee.