Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04985110
Other study ID # 21-02-0154
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date July 6, 2021
Est. completion date July 6, 2023

Study information

Verified date July 2021
Source Indonesia University
Contact Agus Rizal A. H. Hamid, MD, PhD
Phone +628111803377
Email rizalhamid.urology@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This randomized controlled trial aims to compare the rate of perioperative infection complications in transperineal prostate biopsy between the group that receives prophylactic antibiotic and the group that receives placebo. The types of infection studied included bacteriuria, urinary tract infection (UTI), UTI with fever (febrile UTI), and sepsis. This study hypothesized that the administration of prophylactic antibiotics during transperineal prostate biopsy would result in lower rates of perioperative infection complications.


Description:

Prostate cancer screenings will be conducted in all patients aged >45 years with lower urinary tract symptoms (LUTS) through PSA test and digital rectal examination (DRE). Those with PSA levels of 4.0 ng/mL or higher or other abnormal findings on DRE will be recommended to undergo transperineal prostate biopsy. In addition, participants will be offered to participate in this clinical trial, in which participants will be randomly assigned into two groups: one group will receive prophylactic antibiotic, while the other group will receive placebo. The randomization process will be conducted before the biopsy procedure. Computers will generate random numbers, which will put the participants into two groups. These numbers can only be accessed by the research monitor (Clinical Research Supporting Unit of IMERI FMUI), while the investigators, surgeons, residents, and nurses involved will be blinded to this information. To ensure patient blinding, the placebo and cotrimoxazole forte 960 mg will be reformed as identical as possible in capsule preparation. The primary outcomes of this clinical trial are the rate of perioperative infection complications, including bacteriuria, urinary tract infection (UTI), UTI with fever (febrile UTI), and sepsis, in 24 hours, 7 days, and 14 days postoperatively. The secondary outcomes of this clinical trial are the rate of readmission.


Recruitment information / eligibility

Status Recruiting
Enrollment 78
Est. completion date July 6, 2023
Est. primary completion date July 6, 2023
Accepts healthy volunteers No
Gender Male
Age group 45 Years and older
Eligibility Inclusion Criteria: - Patient with lower urinary tract symptoms aged >45 years with either PSA levels of 4.0 ng/mL or higher or abnormal findings on digital rectal examination (DRE) - Patient with a negative initial urine culture / urinalysis test Exclusion Criteria: - Patients who refuses to undergo transperineal prostate biopsy - Patients who refuses to participate in the research - Patient who is unable to communicate effectively - Patient with a documented history of cotrimoxazole allergy - Patient who has consumed antibiotics for other indications prior to undergoing prostate biopsy - Patient with urinary tract infection symptoms prior to undergoing prostate biopsy - Patient with a history of immunodeficiency disorders or long-term corticosteroid use - Patient with a history of prostate cancer - Patient with a history of prior prostate biopsy

Study Design


Intervention

Drug:
Cotrimoxazole
The treatment group will receive Cotrimoxazole Forte 960 mg PO q.d. 4 hours before the biopsy procedure.
Placebo
The placebo group will receive placebo q.d. 4 hours before the biopsy procedure.

Locations

Country Name City State
Indonesia Dr. Cipto Mangunkusumo Hospital Jakarta Pusat DKI Jakarta

Sponsors (1)

Lead Sponsor Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of infection complications The rate of infection complications, including bacteriuria, urinary tract infection (UTI), UTI with fever (febrile UTI), and sepsis, will be measured in both treatment and placebo groups in 24 hours postoperatively. 24 hours
Primary Incidence of infection complications The rate of infection complications, including bacteriuria, urinary tract infection (UTI), UTI with fever (febrile UTI), and sepsis, will be measured in both treatment and placebo groups in 7 days postoperatively. 7 days
Primary Incidence of infection complications The rate of infection complications, including bacteriuria, urinary tract infection (UTI), UTI with fever (febrile UTI), and sepsis, will be measured in both treatment and placebo groups in 14 days postoperatively. 14 days
Secondary Rate of readmission The rate of readmission will also be assessed in 7 days postoperatively. 7 days
Secondary Rate of readmission The rate of readmission will also be assessed in 14 days postoperatively. 14 days
See also
  Status Clinical Trial Phase
Recruiting NCT05613023 - A Trial of 5 Fraction Prostate SBRT Versus 5 Fraction Prostate and Pelvic Nodal SBRT Phase 3
Recruiting NCT05540392 - An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues Phase 1/Phase 2
Recruiting NCT05156424 - A Comparison of Aerobic and Resistance Exercise to Counteract Treatment Side Effects in Men With Prostate Cancer Phase 1/Phase 2
Completed NCT03177759 - Living With Prostate Cancer (LPC)
Completed NCT01331083 - A Phase II Study of PX-866 in Patients With Recurrent or Metastatic Castration Resistant Prostate Cancer Phase 2
Recruiting NCT05540782 - A Study of Cognitive Health in Survivors of Prostate Cancer
Active, not recruiting NCT04742361 - Efficacy of [18F]PSMA-1007 PET/CT in Patients With Biochemial Recurrent Prostate Cancer Phase 3
Completed NCT04400656 - PROState Pathway Embedded Comparative Trial
Completed NCT02282644 - Individual Phenotype Analysis in Patients With Castration-Resistant Prostate Cancer With CellSearch® and Flow Cytometry N/A
Recruiting NCT06305832 - Salvage Radiotherapy Combined With Androgen Deprivation Therapy (ADT) With or Without Rezvilutamide in the Treatment of Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer Phase 2
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A
Recruiting NCT05761093 - Patient and Physician Benefit/ Risk Preferences for Treatment of mPC in Hong Kong: a Discrete Choice Experiment
Completed NCT04838626 - Study of Diagnostic Performance of [18F]CTT1057 for PSMA-positive Tumors Detection Phase 2/Phase 3
Recruiting NCT03101176 - Multiparametric Ultrasound Imaging in Prostate Cancer N/A
Completed NCT03290417 - Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Prostate Cancer N/A
Completed NCT00341939 - Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
Completed NCT01497925 - Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer Phase 1
Recruiting NCT03679819 - Single-center Trial for the Validation of High-resolution Transrectal Ultrasound (Exact Imaging Scanner ExactVu) for the Detection of Prostate Cancer
Completed NCT03554317 - COMbination of Bipolar Androgen Therapy and Nivolumab Phase 2
Completed NCT03271502 - Effect of Anesthesia on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy N/A