BRCA1 SyndromeNCT02053805
Prostate Cancer Screening Among Men With High Risk Genetic Predisposition
A study testing PSA, IPSS questionnaire and DRE (Digital Rectal Examination ) in people with BRCA1 Syndrome and BRCA2 Syndrome, run by Rabin Medical Center at 2 sites in Israel.
Trial summary
This will be a prospective diagnostic trial of screening for prostate cancer among men with genetic predisposition. Read more about this study
- Who is it for?
- Ages 40 to 70 years, men only
- Conditions the study is for
- BRCA1 Syndrome, BRCA2 Syndrome, Lynch Syndrome
- What is being tested?
- PSA, IPSS questionnaire and DRE (Digital Rectal Examination )
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesIsrael
- Study dates
- Feb 2014to Jun 2019
- 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 40 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male carrier of mutation in BRCA 1\2 or germ-line mutations in the MMR genes (MLH1, MSH2 , MSH6 or PMS2).
- WHO performance status 0-2 (Appendix 2)
- Absence of any psychological, familial, sociological or geographical situation potentially hampering compliance with the study protocol and follow-up schedule.
- Individuals that cannot undergo the MRI exam due to high creatinine level or claustrophobic will be disc loud from the MRI part.
- Informed written consent must be sought according to ICH/EU GCP, before subject registration.
Who cannot join
- Previous cancer with a terminal prognosis of less than five years.
- Previous prostate cancer
Trial locations and contacts
2 sites in 1 country.
Israel2 sites, 2 recruiting
- Recruiting
Rabin Medical Center - Beilinson Hospital
Petah Tikva, 4941492
Rachel Ozalvo, B.sc MBA, 972-3-9376553, racheloz@gmail.com
David Margel, MD, PhD, 972-3-9376553, sdmargel@gmail.com
- Recruiting
Rabin Medical Center, Beilinson Hospital
Petah Tikva
David Margel, MD PhD, +972(0)39378089
David Margel, MD Phd
About this study
Official title: Personalized Prostate Cancer Screening Among Men With High Risk Genetic Predisposition- a Prospective Cohort Study
This will be a prospective diagnostic trial of screening for prostate cancer among men with genetic predisposition.
Read the detailed description
This will be a prospective diagnostic trial of screening for prostate cancer among men with genetic predisposition. The target population is males (40-70 year old) carrying a BRCA1 and/or BRCA2 germ line mutation. They will be identified via our Genetic counseling unit. All men after signing an informed consent will undergo the following tests: PSA, free to total PSA, MRI of prostate and prostate biopsy. The primary endpoint will be to estimate the prevalence, stage and grade of prostate cancer in this population. Additionally, the study aims to estimate the impact of these germ line mutations on benign prostatic hyperplasia. Furthermore, this study aims to create a bio-bank of tissue, urine and serum of this unique cohort for future investigations. Finally, this study will identify an inception cohort for future interventional studies of primary and secondary prevention.
- Conditions
- BRCA1 Syndrome, BRCA2 Syndrome, Lynch Syndrome
- Being tested
- PSA, IPSS questionnaire, DRE (Digital Rectal Examination ), urine flow and residual, a multiparametric prostate MRI
- Keywords
- prostate cancer, BRCA1 Syndrome, BRCA germ-line mutation, Lynch syndrome, BRCA2 Syndrome
- Medical subject headings
- Colorectal Neoplasms, Hereditary Nonpolyposis, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSAOther
PSA. Serum \& plasma will be stored for future investigations
IPSS questionnaireOther
the validated International Prostate Symptom Score
DRE (Digital Rectal Examination )Other
physical examination for the prostate gland
urine flow and residualOther
The post void residual will be recorded by using ultrasound. Creatinine level will be checked.
a multiparametric prostate MRIProcedure or surgery
The MRI will be reported on a 5 point Likert Scale
trans-rectal ultra-sound guided prostate biopsyProcedure or surgery
12 core Trans-rectal prostatic biopsy for diagnostic purposes
| Study group | Role | What they receive |
|---|---|---|
| screening tests | Other | The screening will include: DRE, PSA , a multiparametric prostate MRI and a trans-rectal ultra-sound guided prostate biopsy/ MRI-US fusion , IPSS questionnaire, trans-rectal US assessment of prostate size, urine flow and residual. Receives: Other: PSA; Other: IPSS questionnaire; Other: DRE (Digital Rectal Examination ); Other: urine flow and residual; Procedure: a multiparametric prostate MRI; Procedure: trans-rectal ultra-sound guided prostate biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence, stage and pathology of screen-detected prostate cancer in BRCA1/BRCA2 founder mutation carriers and Lynch mutation carriers
Measured: within 2 years
Secondary outcomes (1)
Accuracy of different screening tests (PSA, free to total PSA, prostate MRI) in detecting prostate cancer among men with genetic predispositions.
Measured: within 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionJun 2018 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for BRCA1 SyndromeStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Margel, MD PhD, Principal investigator, Rabn Medical Center, Beilinson Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02053805
- Sponsor's protocol ID
- 0582_13_RMC
- Status last verified
- Oct 2017
- First submitted
- 30 Jan 2014
- Last updated
- 17 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Segal N, Ber Y, Benjaminov O, Tamir S, Yakimov M, Kedar I, Rosenbaum E, Sela S, Ozalvo R, Shavit-Grievink L, Keder D, Baniel J, Margel D. Imaging-based prostate cancer screening among BRCA mutation carriers-results from the first round of screening. Ann Oncol. 2020 Nov;31(11):1545-1552. doi: 10.1016/j.annonc.2020.06.025. Epub 2020 Sep 18.
PubMed 32958357Margel D, Benjaminov O, Ozalvo R, Shavit Grievink L, Kedar I, Yerushalmi R, Ben-Aharon I, Neiman V, Yossepowitch O, Kedar D, Levy Z, Shohat M, Brenner B, Baniel J, Rosenbaum E. Personalized prostate cancer screening among men with high risk genetic predisposition- study protocol for a prospective cohort study. BMC Cancer. 2014 Jul 21;14:528. doi: 10.1186/1471-2407-14-528.
PubMed 25047061
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Prostate Cancer Screening Among Men With High Risk Genetic Predisposition- a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT02053805
- Acronym / sponsor ID
- 0582_13_RMC
- Conditions
- BRCA1 Syndrome, BRCA2 Syndrome, Lynch Syndrome
- Keywords
- prostate cancer, BRCA1 Syndrome, BRCA germ-line mutation, Lynch syndrome, BRCA2 Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 4 Feb 2014 (estimated)
- 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 will be a prospective diagnostic trial of screening for prostate cancer among men with genetic predisposition.
Detailed description
This will be a prospective diagnostic trial of screening for prostate cancer among men with genetic predisposition. The target population is males (40-70 year old) carrying a BRCA1 and/or BRCA2 germ line mutation. They will be identified via our Genetic counseling unit. All men after signing an informed consent will undergo the following tests: PSA, free to total PSA, MRI of prostate and prostate biopsy. The primary endpoint will be to estimate the prevalence, stage and grade of prostate cancer in this population. Additionally, the study aims to estimate the impact of these germ line mutations on benign prostatic hyperplasia. Furthermore, this study aims to create a bio-bank of tissue, urine and serum of this unique cohort for future investigations. Finally, this study will identify an inception cohort for future interventional studies of primary and secondary prevention.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| screening tests | Other | Other: PSA, Other: IPSS questionnaire, Other: DRE (Digital Rectal Examination ), Other: urine flow and residual, Procedure: a multiparametric prostate MRI, Procedure: trans-rectal ultra-sound guided prostate biopsyThe screening will include: DRE, PSA , a multiparametric prostate MRI and a trans-rectal ultra-sound guided prostate biopsy/ MRI-US fusion , IPSS questionnaire, trans-rectal US assessment of prostate size, urine flow and residual. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male carrier of mutation in BRCA 1\2 or germ-line mutations in the MMR genes (MLH1, MSH2 , MSH6 or PMS2).
- WHO performance status 0-2 (Appendix 2)
- Absence of any psychological, familial, sociological or geographical situation potentially hampering compliance with the study protocol and follow-up schedule.
- Individuals that cannot undergo the MRI exam due to high creatinine level or claustrophobic will be disc loud from the MRI part.
- Informed written consent must be sought according to ICH/EU GCP, before subject registration.
Key exclusion criteria (2 listed)
- Previous cancer with a terminal prognosis of less than five years.
- Previous prostate cancer
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 |
|---|---|---|
| PSAPSA. Serum \& plasma will be stored for future investigations | Other | screening tests |
| IPSS questionnairethe validated International Prostate Symptom Score | Other | screening tests |
| DRE (Digital Rectal Examination )physical examination for the prostate gland | Other | screening tests |
| urine flow and residualThe post void residual will be recorded by using ultrasound. Creatinine level will be checked. | Other | screening tests |
| a multiparametric prostate MRIThe MRI will be reported on a 5 point Likert Scale | Procedure or surgery | screening tests |
| trans-rectal ultra-sound guided prostate biopsy12 core Trans-rectal prostatic biopsy for diagnostic purposes | Procedure or surgery | screening tests |
Primary outcome
Prevalence, stage and pathology of screen-detected prostate cancer in BRCA1/BRCA2 founder mutation carriers and Lynch mutation carriers
Time frame: within 2 years
1 secondary outcome
Accuracy of different screening tests (PSA, free to total PSA, prostate MRI) in detecting prostate cancer among men with genetic predispositions.
Time frame: within 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2017.
- Derived from this study: PubMed 32958357Segal N, Ber Y, Benjaminov O, Tamir S, Yakimov M, Kedar I, Rosenbaum E, Sela S, Ozalvo R, Shavit-Grievink L, Keder D, Baniel J, Margel D. Imaging-based prostate cancer screening among BRCA mutation carriers-results from the first round of screening. Ann Oncol. 2020 Nov;31(11):1545-1552. doi: 10.1016/j.annonc.2020.06.025. Epub 2020 Sep 18.
- Derived from this study: PubMed 25047061Margel D, Benjaminov O, Ozalvo R, Shavit Grievink L, Kedar I, Yerushalmi R, Ben-Aharon I, Neiman V, Yossepowitch O, Kedar D, Levy Z, Shohat M, Brenner B, Baniel J, Rosenbaum E. Personalized prostate cancer screening among men with high risk genetic predisposition- study protocol for a prospective cohort study. BMC Cancer. 2014 Jul 21;14:528. doi: 10.1186/1471-2407-14-528.
- 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.
David Margel, MD PhD principal investigator
Rabn Medical Center, Beilinson Campus
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PSA, IPSS questionnaire and DRE (Digital Rectal Examination ) in people with BRCA1 Syndrome and BRCA2 Syndrome, run by Rabin Medical Center at 2 sites in Israel.
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: status not confirmed, as of the sponsor's last update on 17 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rachel Ozalvo, B.sc, MBA (+972(0)3-9376553, racheloz@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence, stage and pathology of screen-detected prostate cancer in BRCA1/BRCA2 founder mutation carriers and Lynch mutation carriers (time frame: within 2 years). 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 NCT02053805, which also lists 2 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 17 Oct 2017.