PainNCT04064047

Anorectal Application of 5% Lidocaine Cream Reduces Pain Prior to Periprostatic Nerve Block During Transrectal Ultrasound Guided Biopsy

A study testing Trans rectal ultrasound guided prostate biopsy, Trans rectal ultrasound and Prostate biopsy in people with Pain and Prostate Cancer, run by Assaf-Harofeh Medical Center.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Transrectal ultrasound guided prostate biopsy is performed with a periprostatic nerve block to the neurovascular bundle bilaterally. This does not reduce the pain due to probe insertion and manipulation prior to nerve blockage. Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Pain, Prostate Cancer, Rectal/Anal
What is being tested?: Trans rectal ultrasound guided prostate biopsy, Trans rectal ultrasound and Prostate biopsy
Type of treatment: Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 284 participants
Where: No sites listed yet
Study dates: Dec 2016to Jul 2017
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 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Males referred to TRUSGBx due to elevated prostate specific antigen (PSA)
Abnormal findings on digital rectal examination (DRE)
Repeat biopsies as part of Active Surveillance (AS)
Continuously elevated PSA levels despite prior negative for malignancy biopsies
Previous histological findings of significant HGPIN were enrolled

Who cannot join

Known sensitivity to Lidocaine
Pre-planned biopsy under general anesthesia

About this study

Official title: Anorectal Application of 5% Lidocaine Cream Reduces Pain Prior to Periprostatic Nerve Block During Transrectal Ultrasound Guided Biopsy: Randomized, Prospective Controlled Study

Our study goal is to assess whether topical analgesia would reduce pain during the early stages of the procedure.

Read the detailed description

Prospective, randomized controlled study. Patients signed an informed consent form. Exclusion criteria were Lidocaine allergy or pre-planned general anesthesia.

Patients were randomized into 6 groups: (1) nerve block with 5 ml 1% lidocaine for each neurovascular bundle + perianal topical application of 10 ml 5% lidocaine cream; (2) as in (1) plus application of 10 ml 5% lidocaine cream evenly on rectal walls. For each approach exposure times of 5, 10 and 20 minutes were allowed, all together 6 groups plus a control group of patients who received periprostatic nerve block only. A 0-10 Visual analogue scale (VAS) was filled by the patients at 5 time points: immediately after probe insertion, during probe manipulation and prostate assessment, immediately following neurovascular bundle nerve blockage, after prostate biopsies and a global pain estimation of the procedure.

Conditions: Pain, Prostate Cancer, Rectal/Anal
Being tested: Trans rectal ultrasound guided prostate biopsy, Trans rectal ultrasound, Prostate biopsy, Periprostatic nerve block
Medical subject headings: Pain, Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Trans rectal ultrasound guided prostate biopsyProcedure or surgery
The investigators checked visual analogue scale of pain at different time periods: prior to probe insertion, during probe insertion. during probe manipulation in the rectum, during performance of periprostatic nerve block, during actual biopsy collection and at termination of procedure.
Trans rectal ultrasoundProcedure or surgery
Also called BK pro focus 2202 transrectal ultrasound and the 8808 bi-plane transrectal probe
Performing a prostate biopsy using a transrectal ultrasound probe - the BK pro focus 2202 transrectal ultrasound and the 8808 bi-plane transrectal probe
Prostate biopsyProcedure or surgery
Prostate biopsy guided by a transrectal ultrasound with an 18 gauge needle
Periprostatic nerve blockProcedure or surgery
Performing a bilateral peri-prostatic nerve block with 10 mL of 1% lidocaine (5 mL on each side)

Study groups in NCT04064047
Study group	Role	What they receive
External Anal application - 5 minutes exposure	Active comparator	Anal application of lidocaine cream 5% for 5 minutes before probe insertion. After probe insertion and prior to biopsy, a periprostatic nerve block was performed with 10 mL of 1% Lidocaine (5 mL on each side). Receives: Procedure: Trans rectal ultrasound guided prostate biopsy; Procedure: Trans rectal ultrasound; Procedure: Prostate biopsy; Procedure: Periprostatic nerve block
External Anal application - 10 minutes exposure	Active comparator	Anal application of lidocaine cream 5% for 10 minutes before probe insertion. After probe insertion and prior to biopsy, a periprostatic nerve block was performed with 10 mL of 1% Lidocaine (5 mL on each side). Receives: Procedure: Trans rectal ultrasound guided prostate biopsy; Procedure: Trans rectal ultrasound; Procedure: Prostate biopsy; Procedure: Periprostatic nerve block
External Anal application - 20 minutes exposure	Active comparator	Anal application of lidocaine cream 5% for 20 minutes before probe insertion. After probe insertion and prior to biopsy, a periprostatic nerve block was performed with 10 mL of 1% Lidocaine (5 mL on each side). Receives: Procedure: Trans rectal ultrasound guided prostate biopsy; Procedure: Trans rectal ultrasound; Procedure: Prostate biopsy; Procedure: Periprostatic nerve block
External Anal plus intrarectal - 5 minutes exposure	Active comparator	Anal application plus intrarectal application of 5% lidocaine cream for 5 minutes before probe insertion. After probe insertion and prior to biopsy, a periprostatic nerve block was performed with 10 mL of 1% Lidocaine (5 mL on each side). Receives: Procedure: Trans rectal ultrasound guided prostate biopsy; Procedure: Trans rectal ultrasound; Procedure: Prostate biopsy; Procedure: Periprostatic nerve block
External Anal plus intrarectal - 10 minutes exposure	Active comparator	Anal application plus intrarectal application of 5% lidocaine cream for 10 minutes before probe insertion. After probe insertion and prior to biopsy, a periprostatic nerve block was performed with 10 mL of 1% Lidocaine (5 mL on each side). Receives: Procedure: Trans rectal ultrasound guided prostate biopsy; Procedure: Trans rectal ultrasound; Procedure: Prostate biopsy; Procedure: Periprostatic nerve block
External Anal plus intrarectal - 20 minutes exposure	Active comparator	Anal application plus intrarectal application of 5% lidocaine cream for 20 minutes before probe insertion. After probe insertion and prior to biopsy, a periprostatic nerve block was performed with 10 mL of 1% Lidocaine (5 mL on each side). Receives: Procedure: Trans rectal ultrasound guided prostate biopsy; Procedure: Trans rectal ultrasound; Procedure: Prostate biopsy; Procedure: Periprostatic nerve block
Control group	Sham comparator	No anal application of lidocaine cream prior to probe insertion. After probe insertion and prior to biopsy, a periprostatic nerve block was performed with 10 mL of 1% Lidocaine (5 mL on each side). Receives: Procedure: Trans rectal ultrasound guided prostate biopsy; Procedure: Trans rectal ultrasound; Procedure: Prostate biopsy; Procedure: Periprostatic nerve block

What is being measured

The primary outcome is the main question the study is designed to answer.

Pain level before probe insertion
Self reported by the patient using a 0-10 visual analogue scale. 0 being no pain at all, 10 being worst pain imaginable.
Measured: Before transrectal ultrasound probe insertion
Pain level at TRUS probe insertion
Self reported by the patient using a 0-10 visual analogue scale. 0 being no pain at all, 10 being worst pain imaginable.
Measured: During transrectal ultrasound probe insertion into the rectum (defined as beginning of procedure)
Pain level during TRUS probe manipulation in the rectum
Self reported by the patient using a 0-10 visual analogue scale. 0 being no pain at all, 10 being worst pain imaginable.
Measured: During transrectal ultrasound probe manipulation in the rectum (estimated at 0-2 minutes length)
Pain level during periprostatic nerve block
Self reported by the patient using a 0-10 visual analogue scale. 0 being no pain at all, 10 being worst pain imaginable.
Measured: During periprostatic nerve block (rectal wall puncture with needle, estimated at 2-3 minutes after beginning of procedure)
Pain level during biopsy collection
Self reported by the patient using a 0-10 visual analogue scale. 0 being no pain at all, 10 being worst pain imaginable.
Measured: During biopsy collection using an 18-gauge needle (estimated at 3-10 minutes from beginning of procedure)
Pain level at termination of procedure
Self reported by the patient using a 0-10 visual analogue scale. 0 being no pain at all, 10 being worst pain imaginable.
Measured: At termination of procedure (total estimated length of procedure is 10 minutes).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2016Jul 2017

First posted21 Aug 2019
Study startDec 2016
Primary completionJul 2017
Study completionJul 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for PainStudies 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: Supportive care
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind
Who is masked: Participant
Enrolment: 284 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04064047
Sponsor's protocol ID: Assaf-HarofehMC 0289-15-ASF
Status last verified: Jan 2020
First submitted: 20 Jan 2019
Last updated: 13 Jan 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Lee C, Woo HH. Current methods of analgesia for transrectal ultrasonography (TRUS)-guided prostate biopsy -- a systematic review. BJU Int. 2014 Mar;113 Suppl 2:48-56. doi: 10.1111/bju.12433.
PubMed 24053451
Tiong HY, Liew LC, Samuel M, Consigliere D, Esuvaranathan K. A meta-analysis of local anesthesia for transrectal ultrasound-guided biopsy of the prostate. Prostate Cancer Prostatic Dis. 2007;10(2):127-36. doi: 10.1038/sj.pcan.4500935. Epub 2007 Jan 9.
PubMed 17211441
Wang J, Wang L, Du Y, He D, Chen X, Li L, Nan X, Fan J. Addition of intrarectal local analgesia to periprostatic nerve block improves pain control for transrectal ultrasonography-guided prostate biopsy: a systematic review and meta-analysis. Int J Urol. 2015 Jan;22(1):62-8. doi: 10.1111/iju.12595. Epub 2014 Aug 21.
PubMed 25141759
Raber M, Scattoni V, Roscigno M, Deho F, Briganti A, Salonia A, Gallina A, Di Girolamo V, Montorsi F, Rigatti P. Topical prilocaine-lidocaine cream combined with peripheral nerve block improves pain control in prostatic biopsy: results from a prospective randomized trial. Eur Urol. 2008 May;53(5):967-73. doi: 10.1016/j.eururo.2007.09.005. Epub 2007 Sep 18.
PubMed 17904278
Giannarini G, Autorino R, Valent F, Mogorovich A, Manassero F, De Maria M, Morelli G, Barbone F, Di Lorenzo G, Selli C. Combination of perianal-intrarectal lidocaine-prilocaine cream and periprostatic nerve block for pain control during transrectal ultrasound guided prostate biopsy: a randomized, controlled trial. J Urol. 2009 Feb;181(2):585-91; discussion 591-3. doi: 10.1016/j.juro.2008.10.002. Epub 2008 Dec 13.
PubMed 19084860
Barcohana N, Duperon DF, Yashar M. The relationship of application time to EMLA efficacy. J Dent Child (Chic). 2003 Jan-Apr;70(1):51-4.
PubMed 12762609

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Anorectal Application of 5% Lidocaine Cream Reduces Pain Prior to Periprostatic Nerve Block During Transrectal Ultrasound Guided Biopsy: Randomized, Prospective Controlled Study
ClinicalTrials.gov ID: NCT04064047
Acronym / sponsor ID: Assaf-HarofehMC 0289-15-ASF
Conditions: Pain, Prostate Cancer, Rectal/Anal
Study type: Interventional
Recruitment status: Completed
Enrolment: 284 participants (actual)
Lead sponsor: Assaf-Harofeh Medical CenterOther government
Study start: Dec 2016 (actual)
Primary completion: Jul 2017 (actual)
Study completion: Jul 2017 (actual)
First posted: 21 Aug 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.

Our study goal is to assess whether topical analgesia would reduce pain during the early stages of the procedure.

Detailed description

Prospective, randomized controlled study. Patients signed an informed consent form. Exclusion criteria were Lidocaine allergy or pre-planned general anesthesia.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind (participant)
Number of arms: 7

Arm	Type	Receives
External Anal application - 5 minutes exposure	Active comparator	Procedure: Trans rectal ultrasound guided prostate biopsy, Procedure: Trans rectal ultrasound, Procedure: Prostate biopsy, Procedure: Periprostatic nerve blockAnal application of lidocaine cream 5% for 5 minutes before probe insertion. After probe insertion and prior to biopsy, a periprostatic nerve block was performed with 10 mL of 1% Lidocaine (5 mL on each side).
External Anal application - 10 minutes exposure	Active comparator	Procedure: Trans rectal ultrasound guided prostate biopsy, Procedure: Trans rectal ultrasound, Procedure: Prostate biopsy, Procedure: Periprostatic nerve blockAnal application of lidocaine cream 5% for 10 minutes before probe insertion. After probe insertion and prior to biopsy, a periprostatic nerve block was performed with 10 mL of 1% Lidocaine (5 mL on each side).
External Anal application - 20 minutes exposure	Active comparator	Procedure: Trans rectal ultrasound guided prostate biopsy, Procedure: Trans rectal ultrasound, Procedure: Prostate biopsy, Procedure: Periprostatic nerve blockAnal application of lidocaine cream 5% for 20 minutes before probe insertion. After probe insertion and prior to biopsy, a periprostatic nerve block was performed with 10 mL of 1% Lidocaine (5 mL on each side).
External Anal plus intrarectal - 5 minutes exposure	Active comparator	Procedure: Trans rectal ultrasound guided prostate biopsy, Procedure: Trans rectal ultrasound, Procedure: Prostate biopsy, Procedure: Periprostatic nerve blockAnal application plus intrarectal application of 5% lidocaine cream for 5 minutes before probe insertion. After probe insertion and prior to biopsy, a periprostatic nerve block was performed with 10 mL of 1% Lidocaine (5 mL on each side).
External Anal plus intrarectal - 10 minutes exposure	Active comparator	Procedure: Trans rectal ultrasound guided prostate biopsy, Procedure: Trans rectal ultrasound, Procedure: Prostate biopsy, Procedure: Periprostatic nerve blockAnal application plus intrarectal application of 5% lidocaine cream for 10 minutes before probe insertion. After probe insertion and prior to biopsy, a periprostatic nerve block was performed with 10 mL of 1% Lidocaine (5 mL on each side).
External Anal plus intrarectal - 20 minutes exposure	Active comparator	Procedure: Trans rectal ultrasound guided prostate biopsy, Procedure: Trans rectal ultrasound, Procedure: Prostate biopsy, Procedure: Periprostatic nerve blockAnal application plus intrarectal application of 5% lidocaine cream for 20 minutes before probe insertion. After probe insertion and prior to biopsy, a periprostatic nerve block was performed with 10 mL of 1% Lidocaine (5 mL on each side).
Control group	Sham comparator	Procedure: Trans rectal ultrasound guided prostate biopsy, Procedure: Trans rectal ultrasound, Procedure: Prostate biopsy, Procedure: Periprostatic nerve blockNo anal application of lidocaine cream prior to probe insertion. After probe insertion and prior to biopsy, a periprostatic nerve block was performed with 10 mL of 1% Lidocaine (5 mL on each side).

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Males referred to TRUSGBx due to elevated prostate specific antigen (PSA)
Abnormal findings on digital rectal examination (DRE)
Repeat biopsies as part of Active Surveillance (AS)
Continuously elevated PSA levels despite prior negative for malignancy biopsies
Previous histological findings of significant HGPIN were enrolled

Key exclusion criteria (2 listed)

Known sensitivity to Lidocaine
Pre-planned biopsy under 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
Trans rectal ultrasound guided prostate biopsyThe investigators checked visual analogue scale of pain at different time periods: prior to probe insertion, during probe insertion. during probe manipulation in the rectum, during performance of periprostatic nerve block, during actual biopsy collection and at termination of procedure.	Procedure or surgery	Control group, External Anal application - 10 minutes exposure, External Anal application - 20 minutes exposure, External Anal application - 5 minutes exposure, External Anal plus intrarectal - 10 minutes exposure, External Anal plus intrarectal - 20 minutes exposure, External Anal plus intrarectal - 5 minutes exposure
Trans rectal ultrasoundAlso: BK pro focus 2202 transrectal ultrasound and the 8808 bi-plane transrectal probePerforming a prostate biopsy using a transrectal ultrasound probe - the BK pro focus 2202 transrectal ultrasound and the 8808 bi-plane transrectal probe	Procedure or surgery	Control group, External Anal application - 10 minutes exposure, External Anal application - 20 minutes exposure, External Anal application - 5 minutes exposure, External Anal plus intrarectal - 10 minutes exposure, External Anal plus intrarectal - 20 minutes exposure, External Anal plus intrarectal - 5 minutes exposure
Prostate biopsyProstate biopsy guided by a transrectal ultrasound with an 18 gauge needle	Procedure or surgery	Control group, External Anal application - 10 minutes exposure, External Anal application - 20 minutes exposure, External Anal application - 5 minutes exposure, External Anal plus intrarectal - 10 minutes exposure, External Anal plus intrarectal - 20 minutes exposure, External Anal plus intrarectal - 5 minutes exposure
Periprostatic nerve blockPerforming a bilateral peri-prostatic nerve block with 10 mL of 1% lidocaine (5 mL on each side)	Procedure or surgery	Control group, External Anal application - 10 minutes exposure, External Anal application - 20 minutes exposure, External Anal application - 5 minutes exposure, External Anal plus intrarectal - 10 minutes exposure, External Anal plus intrarectal - 20 minutes exposure, External Anal plus intrarectal - 5 minutes exposure

Primary outcome

Pain level before probe insertion
Time frame: Before transrectal ultrasound probe insertion
Self reported by the patient using a 0-10 visual analogue scale. 0 being no pain at all, 10 being worst pain imaginable.
Pain level at TRUS probe insertion
Time frame: During transrectal ultrasound probe insertion into the rectum (defined as beginning of procedure)
Self reported by the patient using a 0-10 visual analogue scale. 0 being no pain at all, 10 being worst pain imaginable.
Pain level during TRUS probe manipulation in the rectum
Time frame: During transrectal ultrasound probe manipulation in the rectum (estimated at 0-2 minutes length)
Self reported by the patient using a 0-10 visual analogue scale. 0 being no pain at all, 10 being worst pain imaginable.
Pain level during periprostatic nerve block
Time frame: During periprostatic nerve block (rectal wall puncture with needle, estimated at 2-3 minutes after beginning of procedure)
Self reported by the patient using a 0-10 visual analogue scale. 0 being no pain at all, 10 being worst pain imaginable.
Pain level during biopsy collection
Time frame: During biopsy collection using an 18-gauge needle (estimated at 3-10 minutes from beginning of procedure)
Self reported by the patient using a 0-10 visual analogue scale. 0 being no pain at all, 10 being worst pain imaginable.
Pain level at termination of procedure
Time frame: At termination of procedure (total estimated length of procedure is 10 minutes).
Self reported by the patient using a 0-10 visual analogue scale. 0 being no pain at all, 10 being worst pain imaginable.

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 13 Jan 2020.
Results publication: PubMed 24053451Lee C, Woo HH. Current methods of analgesia for transrectal ultrasonography (TRUS)-guided prostate biopsy -- a systematic review. BJU Int. 2014 Mar;113 Suppl 2:48-56. doi: 10.1111/bju.12433.
Results publication: PubMed 17211441Tiong HY, Liew LC, Samuel M, Consigliere D, Esuvaranathan K. A meta-analysis of local anesthesia for transrectal ultrasound-guided biopsy of the prostate. Prostate Cancer Prostatic Dis. 2007;10(2):127-36. doi: 10.1038/sj.pcan.4500935. Epub 2007 Jan 9.
Results publication: PubMed 25141759Wang J, Wang L, Du Y, He D, Chen X, Li L, Nan X, Fan J. Addition of intrarectal local analgesia to periprostatic nerve block improves pain control for transrectal ultrasonography-guided prostate biopsy: a systematic review and meta-analysis. Int J Urol. 2015 Jan;22(1):62-8. doi: 10.1111/iju.12595. Epub 2014 Aug 21.
Results publication: PubMed 17904278Raber M, Scattoni V, Roscigno M, Deho F, Briganti A, Salonia A, Gallina A, Di Girolamo V, Montorsi F, Rigatti P. Topical prilocaine-lidocaine cream combined with peripheral nerve block improves pain control in prostatic biopsy: results from a prospective randomized trial. Eur Urol. 2008 May;53(5):967-73. doi: 10.1016/j.eururo.2007.09.005. Epub 2007 Sep 18.
Results publication: PubMed 19084860Giannarini G, Autorino R, Valent F, Mogorovich A, Manassero F, De Maria M, Morelli G, Barbone F, Di Lorenzo G, Selli C. Combination of perianal-intrarectal lidocaine-prilocaine cream and periprostatic nerve block for pain control during transrectal ultrasound guided prostate biopsy: a randomized, controlled trial. J Urol. 2009 Feb;181(2):585-91; discussion 591-3. doi: 10.1016/j.juro.2008.10.002. Epub 2008 Dec 13.
Results publication: PubMed 12762609Barcohana N, Duperon DF, Yashar M. The relationship of application time to EMLA efficacy. J Dent Child (Chic). 2003 Jan-Apr;70(1):51-4.
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.

Judith Ben Zvi study chair

Assaf Harofeh Medical Center ethical committee for experiments in humans

Questions about this trial

What is this clinical trial studying?

A study testing Trans rectal ultrasound guided prostate biopsy, Trans rectal ultrasound and Prostate biopsy in people with Pain and Prostate Cancer, run by Assaf-Harofeh Medical Center.

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 5 inclusion and 2 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 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

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.

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?

Pain level before probe insertion (time frame: Before transrectal ultrasound probe insertion). The study lists 6 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 NCT04064047, which also lists 6 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 13 Jan 2020.