Prostate CancerPhase 2NCT04985110
Administration of Antibiotic Prophylaxis for Transperineal Prostate Biopsy in Cipto Mangunkusumo Hospital
A Phase 2 study testing Cotrimoxazole in people with Prostate Cancer and Prostate Biopsy, run by Universitas Indonesia at 1 site in Indonesia.
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. Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Prostate Cancer, Prostate Biopsy, Perioperative Complication
- What is being tested?
- Cotrimoxazole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteIndonesia
- Study dates
- 6 Jul 2021to 6 Jul 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
Dr. Cipto Mangunkusumo Hospital
Jakarta Pusat, DKI Jakarta, 10430
Agus Rizal AH Hamid, M.D., Ph.D., +628111803377, rizalhamid.urology@gmail.com
Yasmina Zahra Syadza, M.D., +6281314731670, syadza.yz@gmail.com
About this study
Official title: Pemberian Antibiotik Profilaksis Pada Biopsi Prostat Transperineal di RSUPN Dr. Cipto Mangunkusumo: Uji Klinis Acak Terkontrol
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.
Read the detailed 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.
- Conditions
- Prostate Cancer, Prostate Biopsy, Perioperative Complication, Bacteriuria, Urinary Tract Infections, Sepsis
- Being tested
- Cotrimoxazole, Placebo
- Keywords
- Antibiotic prophylaxis, Transperineal prostate biopsy, Randomized controlled trial
- Medical subject headings
- Prostatic Neoplasms, Bacteriuria, Urinary Tract Infections, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CotrimoxazoleDrug
The treatment group will receive Cotrimoxazole Forte 960 mg PO q.d. 4 hours before the biopsy procedure.
PlaceboDrug
The placebo group will receive placebo q.d. 4 hours before the biopsy procedure.
| Study group | Role | What they receive |
|---|---|---|
| Cotrimoxazole | Experimental | The treatment group will receive Cotrimoxazole Forte 960 mg PO q.d. 4 hours before the biopsy procedure. Receives: Drug: Cotrimoxazole |
| Placebo | Placebo comparator | The placebo group will receive placebo q.d. 4 hours before the biopsy procedure. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 14 days
Secondary outcomes (2)
Rate of readmission
The rate of readmission will also be assessed in 7 days postoperatively.
Measured: 7 days
Rate of readmission
The rate of readmission will also be assessed in 14 days postoperatively.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start6 Jul 2021
- Primary completion6 Jul 2023 (estimated)
- Study completion6 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr. Agus Rizal Ardy Hariandy Hamid, Sp.U(K), Ph.D, Universitas Indonesia
- Investigators
- Agus Rizal A. H. Hamid, M.D, Ph.D., Principal investigator, Universitas Indonesia - Cipto Mangunkusumo HospitalHarun Wijanarko Kusuma Putra, M.D, B.Med.Sci(Hons), Study chair, Universitas Indonesia - Cipto Mangunkusumo HospitalSyamsu Hudaya, M.D., Study director, Fatmawati General Hospital, Jakarta - IndonesiaHendy Mirza, M.D., Study director, Persahabatan Central General Hospital, Jakarta - IndonesiaDyandra Parikesit, B.Med.Sc., M.D., Study director, Universitas Indonesia, Depok - Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04985110
- Sponsor's protocol ID
- 21-02-0154
- Status last verified
- Jul 2021
- First submitted
- 26 Jul 2021
- Last updated
- 5 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pemberian Antibiotik Profilaksis Pada Biopsi Prostat Transperineal di RSUPN Dr. Cipto Mangunkusumo: Uji Klinis Acak Terkontrol
- ClinicalTrials.gov ID
- NCT04985110
- Acronym / sponsor ID
- 21-02-0154
- Conditions
- Prostate Cancer, Prostate Biopsy, Perioperative Complication, Bacteriuria, Urinary Tract Infections, Sepsis
- Keywords
- Antibiotic prophylaxis, Transperineal prostate biopsy, Randomized controlled trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 6 Jul 2021 (actual)
- Primary completion
- 6 Jul 2023 (estimated)
- Study completion
- 6 Jul 2023 (estimated)
- First posted
- 2 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cotrimoxazole | Experimental | Drug: CotrimoxazoleThe treatment group will receive Cotrimoxazole Forte 960 mg PO q.d. 4 hours before the biopsy procedure. |
| Placebo | Placebo comparator | Drug: PlaceboThe placebo group will receive placebo q.d. 4 hours before the biopsy procedure. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CotrimoxazoleThe treatment group will receive Cotrimoxazole Forte 960 mg PO q.d. 4 hours before the biopsy procedure. | Drug | Cotrimoxazole |
| PlaceboThe placebo group will receive placebo q.d. 4 hours before the biopsy procedure. | Drug | Placebo |
Primary outcome
Incidence of infection complications
Time frame: 24 hours
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.
Incidence of infection complications
Time frame: 7 days
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.
Incidence of infection complications
Time frame: 14 days
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.
2 secondary outcomes
Rate of readmission
Time frame: 7 days
Rate of readmission
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Agus Rizal A. H. Hamid, M.D, Ph.D. principal investigator
Universitas Indonesia - Cipto Mangunkusumo Hospital
Harun Wijanarko Kusuma Putra, M.D, B.Med.Sci(Hons) study chair
Universitas Indonesia - Cipto Mangunkusumo Hospital
Syamsu Hudaya, M.D. study director
Fatmawati General Hospital, Jakarta - Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cotrimoxazole in people with Prostate Cancer and Prostate Biopsy, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Agus Rizal A. H. Hamid, MD, PhD (+628111803377, rizalhamid.urology@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of infection complications (time frame: 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2021.