A Phase 2 interventional study of Cotrimoxazole and Placebo in Prostate Cancer, Prostate Biopsy and Perioperative Complication, sponsored by Indonesia University. Status unknown at 1 site in Indonesia. Open to male participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2021-08-05.
Sponsored by Indonesia University · Phase 2, Interventional, and Treatment
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.
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.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 78 is above the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Indonesia University is the lead sponsor of 446 studies on the registry; 56 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The treatment group will receive Cotrimoxazole Forte 960 mg PO q.d. 4 hours before the biopsy procedure.
Drug: Cotrimoxazole
The placebo group will receive placebo q.d. 4 hours before the biopsy procedure.
Drug: Placebo
The treatment group will receive Cotrimoxazole Forte 960 mg PO q.d. 4 hours before the biopsy procedure.
The placebo group will receive placebo q.d. 4 hours before the biopsy procedure.
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.
Time frame: 24 hours
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.
Time frame: 7 days
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.
Time frame: 14 days
Rate of readmission
The rate of readmission will also be assessed in 7 days postoperatively.
Time frame: 7 days
Rate of readmission
The rate of readmission will also be assessed in 14 days postoperatively.
Time frame: 14 days
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2021 (actual). Primary completion is estimated for Jul 2023, 24 months after the start.
Of 610 non-industry phase 2 interventional studies under Prostatic Neoplasms, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 39 and three quarters within 86. This study's planned 24 months is below that.
Counting every sponsor, half of 724 studies reached it within 53 months; a quarter within 34 and three quarters within 80.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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