Prostate CancerNCT03650153
Randomized Controlled Trial of MRI Target Biopsy: Transrectal vs. Transperineal
A study testing Trans-rectal MRI targeted Biopsy and Trans-perineal MRI targeted Biopsy in people with Prostate Cancer, run by Princess Al-Johara Al-Ibrahim Cancer Research Center at 1 site in Saudi Arabia.
Trial summary
This prospective study of comparing between Transrectal and transperineal prostate MRI targeted biopsy to provide evidence for clinicians to select the appropriate biopsy approach under different conditions. Read more about this study
- Who is it for?
- Ages Up to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Trans-rectal MRI targeted Biopsy and Trans-perineal MRI targeted Biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Jan 2020to 31 Dec 2022
- 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 Up to 80 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- prostate-specific antigen > 4ng/ml
- Palpation is positive
Who cannot join
- older than 80y
- prostate-specific antigen > 100 ng/ml
Trial locations and contacts
1 site in 1 country.
About this study
This prospective study of comparing between Transrectal and transperineal prostate MRI targeted biopsy to provide evidence for clinicians to select the appropriate biopsy approach under different conditions.
Read the detailed description
This prospective study of comparing transperineal (TP) prostate MRI targeted biopsy with transrectal (TR) prostate MRI targeted biopsy was aimed to provide evidence for clinicians to select the appropriate biopsy approach under different conditions. TP (n = 75) and TR (n = 75) will be performed randomly for 150 patients who are suspicious of prostate cancer (PCa). The cancer detection rate (CDR), complication rate, visual analog scale (VAS) score, most painful procedure, number of repeated biopsy and additional anesthesia, and operating time (starting from lying down on the operating table to getting up) will be recorded.
- Conditions
- Prostate Cancer
- Being tested
- Trans-rectal MRI targeted Biopsy, Trans-perineal MRI targeted Biopsy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans-rectal MRI targeted BiopsyProcedure or surgery
Trans-rectal biopsy of the prostate: A procedure in which a sample of tissue is removed from the prostate using a thin needle that is inserted through the rectum and into the prostate.
Trans-perineal MRI targeted BiopsyProcedure or surgery
Trans-perineal biopsy of the prostate: The sample is removed with a thin needle that is inserted through the skin of the perineum and into the prostate.
| Study group | Role | What they receive |
|---|---|---|
| Trans-rectal MRI targeted Biopsy | Active comparator | Trans-rectal to perform the prostate MRI targeted biopsy The puncture points are at the rectal Receives: Procedure: Trans-rectal MRI targeted Biopsy |
| Trans-perineal MRI targeted Biopsy | Active comparator | Trans-perineal to perform the prostate MRI targeted biopsy The puncture points are at the perineal Receives: Procedure: Trans-perineal MRI targeted Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of positive detections
the rate of positive detections (How many case are Prostate cancer positive)
Measured: 1 year
Secondary outcomes (1)
the incidence rate of each complication
the Incidence of complication rate is the number of complications divided by the number of patients and the number of patients with complications. Complications were separated into those with major or minor sequelae and the proportion of each type that were due to medical error (avoidable).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2018
- Study start1 Jan 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
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.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Princess Al-Johara Al-Ibrahim Cancer Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- danny M Rabah, FRCS, Principal investigator, Surgery Department and Cancer Research Chair, College of Medicine, King Saud University, Saudi Arabia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03650153
- Sponsor's protocol ID
- Danny Rabah Study 2018
- Status last verified
- Apr 2024
- First submitted
- 27 Aug 2018
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of MRI Target Biopsy: Transrectal vs. Transperineal
- ClinicalTrials.gov ID
- NCT03650153
- Acronym / sponsor ID
- Danny Rabah Study 2018
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Princess Al-Johara Al-Ibrahim Cancer Research CenterUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 28 Aug 2018 (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 prospective study of comparing between Transrectal and transperineal prostate MRI targeted biopsy to provide evidence for clinicians to select the appropriate biopsy approach under different conditions.
Detailed description
This prospective study of comparing transperineal (TP) prostate MRI targeted biopsy with transrectal (TR) prostate MRI targeted biopsy was aimed to provide evidence for clinicians to select the appropriate biopsy approach under different conditions. TP (n = 75) and TR (n = 75) will be performed randomly for 150 patients who are suspicious of prostate cancer (PCa). The cancer detection rate (CDR), complication rate, visual analog scale (VAS) score, most painful procedure, number of repeated biopsy and additional anesthesia, and operating time (starting from lying down on the operating table to getting up) will be recorded.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trans-rectal MRI targeted Biopsy | Active comparator | Procedure: Trans-rectal MRI targeted BiopsyTrans-rectal to perform the prostate MRI targeted biopsy The puncture points are at the rectal |
| Trans-perineal MRI targeted Biopsy | Active comparator | Procedure: Trans-perineal MRI targeted BiopsyTrans-perineal to perform the prostate MRI targeted biopsy The puncture points are at the perineal |
Who may qualify
- Ages
- Up to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- prostate-specific antigen > 4ng/ml
- Palpation is positive
Key exclusion criteria (2 listed)
- older than 80y
- prostate-specific antigen > 100 ng/ml
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 MRI targeted BiopsyTrans-rectal biopsy of the prostate: A procedure in which a sample of tissue is removed from the prostate using a thin needle that is inserted through the rectum and into the prostate. | Procedure or surgery | Trans-rectal MRI targeted Biopsy |
| Trans-perineal MRI targeted BiopsyTrans-perineal biopsy of the prostate: The sample is removed with a thin needle that is inserted through the skin of the perineum and into the prostate. | Procedure or surgery | Trans-perineal MRI targeted Biopsy |
Primary outcome
the rate of positive detections
Time frame: 1 year
the rate of positive detections (How many case are Prostate cancer positive)
1 secondary outcome
the incidence rate of each complication
Time frame: 1 year
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 3 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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.
danny M Rabah, FRCS principal investigator
Surgery Department and Cancer Research Chair, College of Medicine, King Saud University, Saudi Arabia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trans-rectal MRI targeted Biopsy and Trans-perineal MRI targeted Biopsy in people with Prostate Cancer, run by Princess Al-Johara Al-Ibrahim Cancer Research Center at 1 site in Saudi Arabia.
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 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 3 Apr 2024. 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 Saudi Arabia. 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?
the rate of positive detections (time frame: 1 year). 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 3 Apr 2024.