Prostate CancerProBE-PCNCT04081636
Prostate Biopsy, Transrectal vs. Transperineal: Efficacy and Complications
A study testing Systematic Transrectal biopsy (TR-Bx), Targeted Transrectal biopsy (TR-Bx) and Systematic Transperineal biopsy (TP-Bx) in people with Prostate Cancer and PSA, run by Albany Medical College at 1 site in United States.
Trial summary
This study evaluates the difference between 2 prostate biopsy methods, transrectal (through the rectal wall) and transperineal (through the skin) needle biopsy. Men who are in need of prostate biopsy due to clinical suspicions of prostate cancer will be randomly assigned (1:1) to either transrectal or transperineal… Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer, PSA, Infection
- What is being tested?
- Systematic Transrectal biopsy (TR-Bx), Targeted Transrectal biopsy (TR-Bx) and Systematic Transperineal biopsy (TP-Bx)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 840 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2019to 31 Dec 2024
- Phase
- Interventional
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients who are scheduled to undergo prostate biopsy for suspected prostate cancer as part of their regular medical care
- Either with or without an MRI
Who cannot join
- Patients with no access to rectum (due to previous rectal surgery)
- Any abnormalities of the perineal skin (e.g. infection)
- Patients whose procedure requires sedation or general anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Randomized Study Comparing Transperineal and Transrectal Prostate Biopsy Efficacy and Complications (ProBE-PC Trial)
This study evaluates the difference between 2 prostate biopsy methods, transrectal (through the rectal wall) and transperineal (through the skin) needle biopsy.
Men who are in need of prostate biopsy due to clinical suspicions of prostate cancer will be randomly assigned (1:1) to either transrectal or transperineal approach.
This research study will scientifically determine if one biopsy method is better than the other in reducing complications and improving cancer detection.
Read the detailed description
There are two ways to take biopsy (tissue) samples from the prostate. The more commonly used method is trans-rectal needle biopsy of the prostate (TR-Bx) with a needle inserted through a probe in the rectum to reach the prostate.
TR-Bx is usually performed in the office, using local anesthesia, and often using a targeted biopsy approach using MRI/ultrasound fusion technique.
Trans-perineal biopsy (TP-Bx) with a needle inserted directly through the skin to reach the prostate.
Typically, TP-BX is performed in the outpatient surgical setting due significant pain associated with the procedure, requiring the use anesthesia and/or sedation.
TP-Bx. procedure is very uncommon in the USA and is often performed using ultrasound alone (less accurate), without the benefit of MRI guided targeted biopsy.
Now, with the availability of new devices, we are able to perform both TR-Bx and TP-Bx using MRI/ultrasound fusion guided targeted approach, in the office setting, using local anesthesia alone.
With the TR-Bx, there has been increasing risk of infection related complications, sepsis and hospital admissions.
The newer approach of biopsy TP-Bx may cause fewer infections and may have a higher accuracy of finding cancer.
Using validated questionnaires such as IIEF-6, IPSS and TRUS-BxQ, this randomized study of TR-BX and TP-Bx will address these questions:
- Differences in the risk of infectious complications
- Differences in the overall cancer detection rate and the high-grade cancer detection rate
- Differences in the hemorrhagic and urinary side effects
- Tolerability of both techniques with local anesthesia alone
- Difference in the results of of MRI/US fusion targeted biopsy
- Differences in the cost of the procedures
- Conditions
- Prostate Cancer, PSA, Infection
- Being tested
- Systematic Transrectal biopsy (TR-Bx), Targeted Transrectal biopsy (TR-Bx), Systematic Transperineal biopsy (TP-Bx), Targeted Transperineal biopsy (TP-Bx)
- Keywords
- Prostate biopsy, PSA, infection, bleeding
- Medical subject headings
- Prostatic Neoplasms, Infections, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systematic Transrectal biopsy (TR-Bx)Procedure or surgery
Also called ultrasound guided
Through the rectum
Targeted Transrectal biopsy (TR-Bx)Procedure or surgery
Also called MRI guided
Through the rectum
Systematic Transperineal biopsy (TP-Bx)Procedure or surgery
Also called ultrasound guided
Through the perineal skin
Targeted Transperineal biopsy (TP-Bx)Procedure or surgery
Also called MRI guided
Through the perineal skin
| Study group | Role | What they receive |
|---|---|---|
| Systematic Transrectal biopsy (TR-Bx) | Active comparator | Ultrasound guided; needle inserted through the rectum to reach the prostate Receives: Procedure: Systematic Transrectal biopsy (TR-Bx) |
| Targeted Transrectal biopsy (TR-Bx) | Active comparator | MRI-guided; needle inserted through the rectum to reach the prostate Receives: Procedure: Targeted Transrectal biopsy (TR-Bx) |
| Systematic Transperineal biopsy (TP-Bx) | Experimental | Ultrasound guided; needle inserted directly through the skin to reach the prostate Receives: Procedure: Systematic Transperineal biopsy (TP-Bx) |
| Targeted Transperineal biopsy (TP-Bx) | Experimental | MRI-guided; needle inserted directly through the skin to reach the prostate Receives: Procedure: Targeted Transperineal biopsy (TP-Bx) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of infectious complications
Whether or not patient had an infection after the biopsy
Measured: 30 days
Clinically significant cancer detection rate
The rate of grade group 2 prostate cancer detected in each study arm
Measured: 14 days
Secondary outcomes (5)
Rate of Bleeding complications
The type of bleeding and its severity (blood in urine or stool)
Measured: 30 days
Tolerability under local anesthesia
Pain scores; Need for additional analgesia
Measured: 30 days
Patient reported urinary function measures using IPSS questionaire
International Prostate Symptoms Score (IPSS) to measure urinary function
Measured: 30 days
Cost of the procedures
Differences in the actual cost of the procedures (including supplies, time)
Measured: 30 days
Patient reported sexual function measures using IIEF questionaire
International Index of Erectile Function (IIEF) to measure sexual dysfunction
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start2 Sep 2019
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized 1:1 to either trans-rectal needle biopsy (TR-Bx) or Trans-perineal biopsy (TP-Bx) of the prostate. Both arms, either with or without MRI guided biopsy
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 840 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albany Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Badar M. Mian, Albany Medical College
- Investigators
- Badar M Mian, MD, Principal investigator, Albany Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04081636
- Sponsor's protocol ID
- 5479
- Acronym
- ProBE-PC
- Status last verified
- Dec 2025
- First submitted
- 5 Sep 2019
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Choi YH, Kang MY, Sung HH, Jeon HG, Chang Jeong B, Seo SI, Jeon SS, Kim CK, Park BK, Lee HM. Comparison of Cancer Detection Rates Between TRUS-Guided Biopsy and MRI-Targeted Biopsy According to PSA Level in Biopsy-Naive Patients: A Propensity Score Matching Analysis. Clin Genitourin Cancer. 2019 Feb;17(1):e19-e25. doi: 10.1016/j.clgc.2018.09.007. Epub 2018 Sep 13.
PubMed 30415878Kasivisvanathan V, Rannikko AS, Borghi M, Panebianco V, Mynderse LA, Vaarala MH, Briganti A, Budaus L, Hellawell G, Hindley RG, Roobol MJ, Eggener S, Ghei M, Villers A, Bladou F, Villeirs GM, Virdi J, Boxler S, Robert G, Singh PB, Venderink W, Hadaschik BA, Ruffion A, Hu JC, Margolis D, Crouzet S, Klotz L, Taneja SS, Pinto P, Gill I, Allen C, Giganti F, Freeman A, Morris S, Punwani S, Williams NR, Brew-Graves C, Deeks J, Takwoingi Y, Emberton M, Moore CM; PRECISION Study Group Collaborators. MRI-Targeted or Standard Biopsy for Prostate-Cancer Diagnosis. N Engl J Med. 2018 May 10;378(19):1767-1777. doi: 10.1056/NEJMoa1801993. Epub 2018 Mar 18.
PubMed 29552975Moldovan PC, Van den Broeck T, Sylvester R, Marconi L, Bellmunt J, van den Bergh RCN, Bolla M, Briers E, Cumberbatch MG, Fossati N, Gross T, Henry AM, Joniau S, van der Kwast TH, Matveev VB, van der Poel HG, De Santis M, Schoots IG, Wiegel T, Yuan CY, Cornford P, Mottet N, Lam TB, Rouviere O. What Is the Negative Predictive Value of Multiparametric Magnetic Resonance Imaging in Excluding Prostate Cancer at Biopsy? A Systematic Review and Meta-analysis from the European Association of Urology Prostate Cancer Guidelines Panel. Eur Urol. 2017 Aug;72(2):250-266. doi: 10.1016/j.eururo.2017.02.026. Epub 2017 Mar 21.
PubMed 28336078Wu YP, Li XD, Ke ZB, Chen SH, Chen PZ, Wei Y, Huang JB, Sun XL, Xue XY, Zheng QS, Xu N. Risk factors for infectious complications following transrectal ultrasound-guided prostate biopsy. Infect Drug Resist. 2018 Sep 17;11:1491-1497. doi: 10.2147/IDR.S171162. eCollection 2018.
PubMed 30271182Borghesi M, Ahmed H, Nam R, Schaeffer E, Schiavina R, Taneja S, Weidner W, Loeb S. Complications After Systematic, Random, and Image-guided Prostate Biopsy. Eur Urol. 2017 Mar;71(3):353-365. doi: 10.1016/j.eururo.2016.08.004. Epub 2016 Aug 17.
PubMed 27543165Liss MA, Ehdaie B, Loeb S, Meng MV, Raman JD, Spears V, Stroup SP. An Update of the American Urological Association White Paper on the Prevention and Treatment of the More Common Complications Related to Prostate Biopsy. J Urol. 2017 Aug;198(2):329-334. doi: 10.1016/j.juro.2017.01.103. Epub 2017 Mar 29.
PubMed 28363690Saade EA, Suwantarat N, Zabarsky TF, Wilson B, Donskey CJ. Fluoroquinolone-Resistant Escherichia coli Infections After Transrectal Biopsy of the Prostate in the Veterans Affairs Healthcare System. Pathog Immun. 2016;1(2):243-257. doi: 10.20411/pai.v1i2.123.
PubMed 27774521Xiang J, Yan H, Li J, Wang X, Chen H, Zheng X. Transperineal versus transrectal prostate biopsy in the diagnosis of prostate cancer: a systematic review and meta-analysis. World J Surg Oncol. 2019 Feb 13;17(1):31. doi: 10.1186/s12957-019-1573-0.
PubMed 30760274Skouteris VM, Crawford ED, Mouraviev V, Arangua P, Metsinis MP, Skouteris M, Zacharopoulos G, Stone NN. Transrectal Ultrasound-guided Versus Transperineal Mapping Prostate Biopsy: Complication Comparison. Rev Urol. 2018;20(1):19-25. doi: 10.3909/riu0785.
PubMed 29942197Roberts MJ, Bennett HY, Harris PN, Holmes M, Grummet J, Naber K, Wagenlehner FME. Prostate Biopsy-related Infection: A Systematic Review of Risk Factors, Prevention Strategies, and Management Approaches. Urology. 2017 Jun;104:11-21. doi: 10.1016/j.urology.2016.12.011. Epub 2016 Dec 19.
PubMed 28007492Altok M, Kim B, Patel BB, Shih YT, Ward JF, McRae SE, Chapin BF, Pisters LL, Pettaway CA, Kim J, Demirel HC, Davis JW. Cost and efficacy comparison of five prostate biopsy modalities: a platform for integrating cost into novel-platform comparative research. Prostate Cancer Prostatic Dis. 2018 Nov;21(4):524-532. doi: 10.1038/s41391-018-0056-7. Epub 2018 Jul 9.
PubMed 29988098Stefanova V, Buckley R, Flax S, Spevack L, Hajek D, Tunis A, Lai E, Loblaw A; Collaborators. Transperineal Prostate Biopsies Using Local Anesthesia: Experience with 1,287 Patients. Prostate Cancer Detection Rate, Complications and Patient Tolerability. J Urol. 2019 Jun;201(6):1121-1126. doi: 10.1097/JU.0000000000000156.
PubMed 30835607Meyer AR, Joice GA, Schwen ZR, Partin AW, Allaf ME, Gorin MA. Initial Experience Performing In-office Ultrasound-guided Transperineal Prostate Biopsy Under Local Anesthesia Using the PrecisionPoint Transperineal Access System. Urology. 2018 May;115:8-13. doi: 10.1016/j.urology.2018.01.021. Epub 2018 Feb 1.
PubMed 29409845Mian BM, Kaufman RP Jr, Berstein A, Fisher HAG. Letter: Complications Following Transrectal and Transperineal Prostate Biopsy: Results of the ProBE-PC Randomized Clinical Trial. J Urol. 2024 Sep;212(3):511-512. doi: 10.1097/JU.0000000000004081. Epub 2024 Jun 7. No abstract available.
PubMed 38847318Mian BM, Feustel PJ, Aziz A, Kaufman RP Jr, Bernstein A, Fisher HAG. Clinically Significant Prostate Cancer Detection Following Transrectal and Transperineal Biopsy: Results of the Prostate Biopsy Efficacy and Complications Randomized Clinical Trial. J Urol. 2024 Jul;212(1):21-31. doi: 10.1097/JU.0000000000003979. Epub 2024 May 3.
PubMed 38700844
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized Study Comparing Transperineal and Transrectal Prostate Biopsy Efficacy and Complications (ProBE-PC Trial)
- ClinicalTrials.gov ID
- NCT04081636
- Acronym / sponsor ID
- ProBE-PC / 5479
- Conditions
- Prostate Cancer, PSA, Infection
- Keywords
- Prostate biopsy, PSA, infection, bleeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 840 participants (actual)
- Lead sponsor
- Albany Medical CollegeUniversity, hospital or other
- Study start
- 2 Sep 2019 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 9 Sep 2019 (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 study evaluates the difference between 2 prostate biopsy methods, transrectal (through the rectal wall) and transperineal (through the skin) needle biopsy.
Men who are in need of prostate biopsy due to clinical suspicions of prostate cancer will be randomly assigned (1:1) to either transrectal or transperineal approach.
This research study will scientifically determine if one biopsy method is better than the other in reducing complications and improving cancer detection.
Detailed description
There are two ways to take biopsy (tissue) samples from the prostate. The more commonly used method is trans-rectal needle biopsy of the prostate (TR-Bx) with a needle inserted through a probe in the rectum to reach the prostate.
TR-Bx is usually performed in the office, using local anesthesia, and often using a targeted biopsy approach using MRI/ultrasound fusion technique.
Trans-perineal biopsy (TP-Bx) with a needle inserted directly through the skin to reach the prostate.
Typically, TP-BX is performed in the outpatient surgical setting due significant pain associated with the procedure, requiring the use anesthesia and/or sedation.
TP-Bx. procedure is very uncommon in the USA and is often performed using ultrasound alone (less accurate), without the benefit of MRI guided targeted biopsy.
Now, with the availability of new devices, we are able to perform both TR-Bx and TP-Bx using MRI/ultrasound fusion guided targeted approach, in the office setting, using local anesthesia alone.
With the TR-Bx, there has been increasing risk of infection related complications, sepsis and hospital admissions.
The newer approach of biopsy TP-Bx may cause fewer infections and may have a higher accuracy of finding cancer.
Using validated questionnaires such as IIEF-6, IPSS and TRUS-BxQ, this randomized study of TR-BX and TP-Bx will address these questions:
- Differences in the risk of infectious complications
- Differences in the overall cancer detection rate and the high-grade cancer detection rate
- Differences in the hemorrhagic and urinary side effects
- Tolerability of both techniques with local anesthesia alone
- Difference in the results of of MRI/US fusion targeted biopsy
- Differences in the cost of the procedures
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Randomized 1:1 to either trans-rectal needle biopsy (TR-Bx) or Trans-perineal biopsy (TP-Bx) of the prostate. Both arms, either with or without MRI guided biopsy
| Arm | Type | Receives |
|---|---|---|
| Systematic Transrectal biopsy (TR-Bx) | Active comparator | Procedure: Systematic Transrectal biopsy (TR-Bx)Ultrasound guided; needle inserted through the rectum to reach the prostate |
| Targeted Transrectal biopsy (TR-Bx) | Active comparator | Procedure: Targeted Transrectal biopsy (TR-Bx)MRI-guided; needle inserted through the rectum to reach the prostate |
| Systematic Transperineal biopsy (TP-Bx) | Experimental | Procedure: Systematic Transperineal biopsy (TP-Bx)Ultrasound guided; needle inserted directly through the skin to reach the prostate |
| Targeted Transperineal biopsy (TP-Bx) | Experimental | Procedure: Targeted Transperineal biopsy (TP-Bx)MRI-guided; needle inserted directly through the skin to reach the prostate |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- All patients who are scheduled to undergo prostate biopsy for suspected prostate cancer as part of their regular medical care
- Either with or without an MRI
Key exclusion criteria (3 listed)
- Patients with no access to rectum (due to previous rectal surgery)
- Any abnormalities of the perineal skin (e.g. infection)
- Patients whose procedure requires sedation or general anesthesia
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 |
|---|---|---|
| Systematic Transrectal biopsy (TR-Bx)Also: ultrasound guidedThrough the rectum | Procedure or surgery | Systematic Transrectal biopsy (TR-Bx) |
| Targeted Transrectal biopsy (TR-Bx)Also: MRI guidedThrough the rectum | Procedure or surgery | Targeted Transrectal biopsy (TR-Bx) |
| Systematic Transperineal biopsy (TP-Bx)Also: ultrasound guidedThrough the perineal skin | Procedure or surgery | Systematic Transperineal biopsy (TP-Bx) |
| Targeted Transperineal biopsy (TP-Bx)Also: MRI guidedThrough the perineal skin | Procedure or surgery | Targeted Transperineal biopsy (TP-Bx) |
Primary outcome
Rate of infectious complications
Time frame: 30 days
Whether or not patient had an infection after the biopsy
Clinically significant cancer detection rate
Time frame: 14 days
The rate of grade group 2 prostate cancer detected in each study arm
5 secondary outcomes
Rate of Bleeding complications
Time frame: 30 days
Tolerability under local anesthesia
Time frame: 30 days
Patient reported urinary function measures using IPSS questionaire
Time frame: 30 days
Cost of the procedures
Time frame: 30 days
Patient reported sexual function measures using IIEF questionaire
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Background: PubMed 30415878Choi YH, Kang MY, Sung HH, Jeon HG, Chang Jeong B, Seo SI, Jeon SS, Kim CK, Park BK, Lee HM. Comparison of Cancer Detection Rates Between TRUS-Guided Biopsy and MRI-Targeted Biopsy According to PSA Level in Biopsy-Naive Patients: A Propensity Score Matching Analysis. Clin Genitourin Cancer. 2019 Feb;17(1):e19-e25. doi: 10.1016/j.clgc.2018.09.007. Epub 2018 Sep 13.
- Background: PubMed 29552975Kasivisvanathan V, Rannikko AS, Borghi M, Panebianco V, Mynderse LA, Vaarala MH, Briganti A, Budaus L, Hellawell G, Hindley RG, Roobol MJ, Eggener S, Ghei M, Villers A, Bladou F, Villeirs GM, Virdi J, Boxler S, Robert G, Singh PB, Venderink W, Hadaschik BA, Ruffion A, Hu JC, Margolis D, Crouzet S, Klotz L, Taneja SS, Pinto P, Gill I, Allen C, Giganti F, Freeman A, Morris S, Punwani S, Williams NR, Brew-Graves C, Deeks J, Takwoingi Y, Emberton M, Moore CM; PRECISION Study Group Collaborators. MRI-Targeted or Standard Biopsy for Prostate-Cancer Diagnosis. N Engl J Med. 2018 May 10;378(19):1767-1777. doi: 10.1056/NEJMoa1801993. Epub 2018 Mar 18.
- Background: PubMed 28336078Moldovan PC, Van den Broeck T, Sylvester R, Marconi L, Bellmunt J, van den Bergh RCN, Bolla M, Briers E, Cumberbatch MG, Fossati N, Gross T, Henry AM, Joniau S, van der Kwast TH, Matveev VB, van der Poel HG, De Santis M, Schoots IG, Wiegel T, Yuan CY, Cornford P, Mottet N, Lam TB, Rouviere O. What Is the Negative Predictive Value of Multiparametric Magnetic Resonance Imaging in Excluding Prostate Cancer at Biopsy? A Systematic Review and Meta-analysis from the European Association of Urology Prostate Cancer Guidelines Panel. Eur Urol. 2017 Aug;72(2):250-266. doi: 10.1016/j.eururo.2017.02.026. Epub 2017 Mar 21.
- Background: PubMed 30271182Wu YP, Li XD, Ke ZB, Chen SH, Chen PZ, Wei Y, Huang JB, Sun XL, Xue XY, Zheng QS, Xu N. Risk factors for infectious complications following transrectal ultrasound-guided prostate biopsy. Infect Drug Resist. 2018 Sep 17;11:1491-1497. doi: 10.2147/IDR.S171162. eCollection 2018.
- Background: PubMed 27543165Borghesi M, Ahmed H, Nam R, Schaeffer E, Schiavina R, Taneja S, Weidner W, Loeb S. Complications After Systematic, Random, and Image-guided Prostate Biopsy. Eur Urol. 2017 Mar;71(3):353-365. doi: 10.1016/j.eururo.2016.08.004. Epub 2016 Aug 17.
- Background: PubMed 28363690Liss MA, Ehdaie B, Loeb S, Meng MV, Raman JD, Spears V, Stroup SP. An Update of the American Urological Association White Paper on the Prevention and Treatment of the More Common Complications Related to Prostate Biopsy. J Urol. 2017 Aug;198(2):329-334. doi: 10.1016/j.juro.2017.01.103. Epub 2017 Mar 29.
- Background: PubMed 27774521Saade EA, Suwantarat N, Zabarsky TF, Wilson B, Donskey CJ. Fluoroquinolone-Resistant Escherichia coli Infections After Transrectal Biopsy of the Prostate in the Veterans Affairs Healthcare System. Pathog Immun. 2016;1(2):243-257. doi: 10.20411/pai.v1i2.123.
- Background: PubMed 30760274Xiang J, Yan H, Li J, Wang X, Chen H, Zheng X. Transperineal versus transrectal prostate biopsy in the diagnosis of prostate cancer: a systematic review and meta-analysis. World J Surg Oncol. 2019 Feb 13;17(1):31. doi: 10.1186/s12957-019-1573-0.
- Background: PubMed 29942197Skouteris VM, Crawford ED, Mouraviev V, Arangua P, Metsinis MP, Skouteris M, Zacharopoulos G, Stone NN. Transrectal Ultrasound-guided Versus Transperineal Mapping Prostate Biopsy: Complication Comparison. Rev Urol. 2018;20(1):19-25. doi: 10.3909/riu0785.
- Background: PubMed 28007492Roberts MJ, Bennett HY, Harris PN, Holmes M, Grummet J, Naber K, Wagenlehner FME. Prostate Biopsy-related Infection: A Systematic Review of Risk Factors, Prevention Strategies, and Management Approaches. Urology. 2017 Jun;104:11-21. doi: 10.1016/j.urology.2016.12.011. Epub 2016 Dec 19.
- Background: PubMed 29988098Altok M, Kim B, Patel BB, Shih YT, Ward JF, McRae SE, Chapin BF, Pisters LL, Pettaway CA, Kim J, Demirel HC, Davis JW. Cost and efficacy comparison of five prostate biopsy modalities: a platform for integrating cost into novel-platform comparative research. Prostate Cancer Prostatic Dis. 2018 Nov;21(4):524-532. doi: 10.1038/s41391-018-0056-7. Epub 2018 Jul 9.
- Background: PubMed 30835607Stefanova V, Buckley R, Flax S, Spevack L, Hajek D, Tunis A, Lai E, Loblaw A; Collaborators. Transperineal Prostate Biopsies Using Local Anesthesia: Experience with 1,287 Patients. Prostate Cancer Detection Rate, Complications and Patient Tolerability. J Urol. 2019 Jun;201(6):1121-1126. doi: 10.1097/JU.0000000000000156.
- 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.
Badar M Mian, MD principal investigator
Albany Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Systematic Transrectal biopsy (TR-Bx), Targeted Transrectal biopsy (TR-Bx) and Systematic Transperineal biopsy (TP-Bx) in people with Prostate Cancer and PSA, run by Albany Medical College at 1 site in United States.
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 3 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: finished, as of the sponsor's last update on 23 Dec 2025. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of infectious complications (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04081636, which also lists 15 linked publications.
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 23 Dec 2025.