Prostate CancerBARCODE1NCT03857477
The BARCODE 1 Study (Full Study): The Use of Genetic Profiling to Guide Prostate Cancer Targeted Screening.
An observational study of Prostate Cancer, run by Institute of Cancer Research, United Kingdom at 1 site in United Kingdom.
Trial summary
BARCODE 1 is a screening study designed to investigate the role of genetic profiling for targeting population prostate cancer screening. A pilot of 300 men were recruited aiming to inform the feasibility and accessibility of the study approach. Read more about this study
- Who is it for?
- Ages 55 to 69 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Genetic SNP profiling, Prostate cancer screening and MRI Scan
- Type of treatment
- Surgery or procedure
- How many people
- 4,700 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Mar 2019to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 55 to 69 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Men of Caucasian ethnicity (not Mixed race or Jewish), aged 55 - 69 years, willing to undergo genetic SNP profiling.
Who may be able to join
- Men aged 55 to 69 years.
- Caucasian ethnicity.
- WHO performance status 0-2.
- Absence of any psychological, familial, sociological or geographical situation potentially hampering compliance with the study protocol and follow-up schedule.
Who cannot join
- Non-Caucasian ethnicity (including mixed race or Ashkenazi Jewish (excluded as these groups have different genetic risk profiles from those being studied).
- Previous diagnosis of cancer with a life-expectancy of less than five years.
- Negative prostate biopsy within one year before recruitment.
- Previous diagnosis of prostate cancer.
- Co-morbidities making prostate biopsy risk unacceptable (anticoagulants or antiplatelet medication including Warfarin, Clopidogrel, Apixaban, Dabigatran or other NOAC medications (Novel Oral Anti-Coagulant); poorly controlled diabetes, cardiovascular/respiratory disease, immunosuppressive medication or splenectomy).
- Men with body mass index (BMI) 40 and above.
Show all 9Show fewer
- Men with BMI 35 and above plus other co-morbidities.
- Contraindications to having an MRI (pacemakers, aneurysm clips, metallic cardiac valve/stent, Ventriculo-Peritoneal (VP) shunt, cochlear implant, neurotransmitter, metallic foreign bodies in eye(s), other metalwork, claustrophobia).
- Any significant psychological conditions that may be worsened or exacerbated by participation in the study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Institute of Cancer Research and Royal Marsden Hospital
Sutton, Surrey, SM2 5PT
About this study
Official title: The BARCODE 1 Study: The Use of Genetic Profiling to Guide Prostate Cancer Targeted Screening.
BARCODE 1 is a screening study designed to investigate the role of genetic profiling for targeting population prostate cancer screening. A pilot of 300 men were recruited aiming to inform the feasibility and accessibility of the study approach. The full study is an extension of the pilot study aiming to recruit a total of 5000 men.
Read the detailed description
The BARCODE 1 study aims to evaluate genetic profiling using the known ~170 prostate cancer (PrCa) risk single-nucleotide polymorphisms (SNPs) as a means of offering targeted screening for PrCa in men at a genetically higher risk. Initially, 300 men were recruited via participating General Practices (GPs). The full study aimed to recruit an additional 4700 participants. Men aged 55-69 years who were likely to be eligible for the study were identified by GPs from medical records. Participants were contacted via invitation letters from GPs and if interested in the study were asked to sign a consent form and complete a questionnaire to confirm eligibility to participate. If eligible, men were then sent a DNA collection saliva kit. DNA from saliva was analysed with SNP profiling for the known ~170 clinically relevant SNPs. Men with a genetic risk equivalent to the top 10% of the population distribution (approximately 470 men in total from the full study) were invited for an MRI and a transperineal (TP) prostate biopsy under local anaesthetic (LA), plus further biological samples. Biopsy results will be correlated with the genetic score. The study also aims to determine the incidence and aggressiveness of prostate cancer in men within the top 10% of the genetic score. Furthermore, the association of MRI appearance and biological sample biomarker profile with prostate biopsy result in men at genetically higher prostate cancer risk undergoing targeted screening will also be determined.
- Conditions
- Prostate Cancer
- Being tested
- Genetic SNP profiling, Prostate cancer screening, MRI Scan, Prostate biopsy
- Keywords
- Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genetic SNP profilingGenetic
Genetic SNP profiling of known prostate cancer predisposition SNPs will be performed on DNA extracted from saliva samples.
Prostate cancer screeningOther
Prostate cancer screening in the form of PSA testing will be offered to all men who have a benign biopsy result for five years in order to track development of cancer in the future.
MRI ScanProcedure or surgery
Also called MRI
MRI scan will be offered to men identified within the top 10% genetic risk score profile.
Prostate biopsyProcedure or surgery
Also called Transperineal Biopsy (TP biopsy)
Transperineal prostate biopsy under local anaesthetic will be offered to men identified within the top 10% genetic risk score profile.
| Study group | Role | What they receive |
|---|---|---|
| Stage 1 | Caucasian men aged 55-69 to undergo genetic SNP profiling. Receives: Genetic: Genetic SNP profiling | |
| Stage 2 | Men from Stage 1 identified as having a higher genetic risk score (top 10%) for prostate cancer will be offered an MRI scan, prostate biopsy and prostate cancer screening. Receives: Genetic: Genetic SNP profiling; Other: Prostate cancer screening; Procedure: MRI Scan; Procedure: Prostate biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association of SNP genetic risk score with prostate biopsy results.
Measured: 5 years
Secondary outcomes (3)
Incidence and aggressiveness of PrCa in men within the top 10% of the genetic score.
Measured: 5 years
Association of the biomarker profile with genetic score and biopsy results.
Measured: 5 years
Use of genetic profiling to target prostate cancer screening in a population screening clinical environment.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2019
- Study start14 Mar 2019
- Primary completion1 Apr 2024
- Study completion31 Dec 2028 (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 Prostate CancerStudies of the same condition, open and under way.
- More trials run by Institute of Cancer Research, United KingdomThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 4,700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Cancer Research, United Kingdom
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rosalind A Eeles, FRCP, FRFR, Principal investigator, Institute of Cancer Research and Royal Marsden Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03857477
- Sponsor's protocol ID
- CCR5044
- Acronym
- BARCODE1
- Status last verified
- Oct 2026
- First submitted
- 26 Feb 2019
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised data can be applied for via the Data Access Committee.
Publications
McHugh JK, Bancroft EK, Saunders E, Brook MN, McGrowder E, Wakerell S, James D, Rageevakumar R, Benton B, Taylor N, Myhill K, Hogben M, Kinsella N, Sohaib AA, Cahill D, Hazell S, Withey SJ, Mcaddy N, Page EC, Osborne A, Benafif S, Jones AB, Patel D, Huang DY, Kaur K, Russell B, Nicholson R, Croft F, Sobczak J, McNally C, Mutch F, Bennett S, Kingston L, Karlsson Q, Dadaev T, Saya S, Merson S, Wood A, Dennis N, Hussain N, Thwaites A, Hussain S, Rafi I, Ferris M, Kumar P, James ND, Pashayan N, Kote-Jarai Z, Eeles RA; BARCODE1 Steering Committee and Collaborators. Assessment of a Polygenic Risk Score in Screening for Prostate Cancer. N Engl J Med. 2025 Apr 10;392(14):1406-1417. doi: 10.1056/NEJMoa2407934.
PubMed 40214032Hogben M, Hainsworth E, Benton B, McHugh J, Myhill K, McGrowder E, Rageevakumar R, James D, Benafif S, Page EC, Eeles RA, Rowland E, Bancroft EK. The psychosocial impact of receiving a polygenic risk score informing risk of prostate cancer. Hered Cancer Clin Pract. 2026 Jul 15. doi: 10.1186/s13053-026-00347-w. Online ahead of print.
PubMed 42458546
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The BARCODE 1 Study: The Use of Genetic Profiling to Guide Prostate Cancer Targeted Screening.
- ClinicalTrials.gov ID
- NCT03857477
- Acronym / sponsor ID
- BARCODE1 / CCR5044
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 4,700 participants (actual)
- Lead sponsor
- Institute of Cancer Research, United KingdomUniversity, hospital or other
- Study start
- 14 Mar 2019 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 28 Feb 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.
BARCODE 1 is a screening study designed to investigate the role of genetic profiling for targeting population prostate cancer screening. A pilot of 300 men were recruited aiming to inform the feasibility and accessibility of the study approach. The full study is an extension of the pilot study aiming to recruit a total of 5000 men.
Detailed description
The BARCODE 1 study aims to evaluate genetic profiling using the known ~170 prostate cancer (PrCa) risk single-nucleotide polymorphisms (SNPs) as a means of offering targeted screening for PrCa in men at a genetically higher risk. Initially, 300 men were recruited via participating General Practices (GPs). The full study aimed to recruit an additional 4700 participants. Men aged 55-69 years who were likely to be eligible for the study were identified by GPs from medical records. Participants were contacted via invitation letters from GPs and if interested in the study were asked to sign a consent form and complete a questionnaire to confirm eligibility to participate. If eligible, men were then sent a DNA collection saliva kit. DNA from saliva was analysed with SNP profiling for the known ~170 clinically relevant SNPs. Men with a genetic risk equivalent to the top 10% of the population distribution (approximately 470 men in total from the full study) were invited for an MRI and a transperineal (TP) prostate biopsy under local anaesthetic (LA), plus further biological samples. Biopsy results will be correlated with the genetic score. The study also aims to determine the incidence and aggressiveness of prostate cancer in men within the top 10% of the genetic score. Furthermore, the association of MRI appearance and biological sample biomarker profile with prostate biopsy result in men at genetically higher prostate cancer risk undergoing targeted screening will also be determined.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stage 1 | – | Genetic: Genetic SNP profilingCaucasian men aged 55-69 to undergo genetic SNP profiling. |
| Stage 2 | – | Genetic: Genetic SNP profiling, Other: Prostate cancer screening, Procedure: MRI Scan, Procedure: Prostate biopsyMen from Stage 1 identified as having a higher genetic risk score (top 10%) for prostate cancer will be offered an MRI scan, prostate biopsy and prostate cancer screening. |
Who may qualify
- Ages
- 55 to 69 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Men of Caucasian ethnicity (not Mixed race or Jewish), aged 55 - 69 years, willing to undergo genetic SNP profiling.
Key inclusion criteria (4 listed)
- Men aged 55 to 69 years.
- Caucasian ethnicity.
- WHO performance status 0-2.
- Absence of any psychological, familial, sociological or geographical situation potentially hampering compliance with the study protocol and follow-up schedule.
Key exclusion criteria (9 listed)
- Non-Caucasian ethnicity (including mixed race or Ashkenazi Jewish (excluded as these groups have different genetic risk profiles from those being studied).
- Previous diagnosis of cancer with a life-expectancy of less than five years.
- Negative prostate biopsy within one year before recruitment.
- Previous diagnosis of prostate cancer.
- Co-morbidities making prostate biopsy risk unacceptable (anticoagulants or antiplatelet medication including Warfarin, Clopidogrel, Apixaban, Dabigatran or other NOAC medications (Novel Oral Anti-Coagulant); poorly controlled diabetes, cardiovascular/respiratory disease, immunosuppressive medication or splenectomy).
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 |
|---|---|---|
| Genetic SNP profilingGenetic SNP profiling of known prostate cancer predisposition SNPs will be performed on DNA extracted from saliva samples. | Genetic | Stage 1, Stage 2 |
| Prostate cancer screeningProstate cancer screening in the form of PSA testing will be offered to all men who have a benign biopsy result for five years in order to track development of cancer in the future. | Other | Stage 2 |
| MRI ScanAlso: MRIMRI scan will be offered to men identified within the top 10% genetic risk score profile. | Procedure or surgery | Stage 2 |
| Prostate biopsyAlso: Transperineal Biopsy (TP biopsy)Transperineal prostate biopsy under local anaesthetic will be offered to men identified within the top 10% genetic risk score profile. | Procedure or surgery | Stage 2 |
Primary outcome
Association of SNP genetic risk score with prostate biopsy results.
Time frame: 5 years
3 secondary outcomes
Incidence and aggressiveness of PrCa in men within the top 10% of the genetic score.
Time frame: 5 years
Association of the biomarker profile with genetic score and biopsy results.
Time frame: 5 years
Use of genetic profiling to target prostate cancer screening in a population screening clinical environment.
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Results publication: PubMed 40214032McHugh JK, Bancroft EK, Saunders E, Brook MN, McGrowder E, Wakerell S, James D, Rageevakumar R, Benton B, Taylor N, Myhill K, Hogben M, Kinsella N, Sohaib AA, Cahill D, Hazell S, Withey SJ, Mcaddy N, Page EC, Osborne A, Benafif S, Jones AB, Patel D, Huang DY, Kaur K, Russell B, Nicholson R, Croft F, Sobczak J, McNally C, Mutch F, Bennett S, Kingston L, Karlsson Q, Dadaev T, Saya S, Merson S, Wood A, Dennis N, Hussain N, Thwaites A, Hussain S, Rafi I, Ferris M, Kumar P, James ND, Pashayan N, Kote-Jarai Z, Eeles RA; BARCODE1 Steering Committee and Collaborators. Assessment of a Polygenic Risk Score in Screening for Prostate Cancer. N Engl J Med. 2025 Apr 10;392(14):1406-1417. doi: 10.1056/NEJMoa2407934.
- Derived from this study: PubMed 42458546Hogben M, Hainsworth E, Benton B, McHugh J, Myhill K, McGrowder E, Rageevakumar R, James D, Benafif S, Page EC, Eeles RA, Rowland E, Bancroft EK. The psychosocial impact of receiving a polygenic risk score informing risk of prostate cancer. Hered Cancer Clin Pract. 2026 Jul 15. doi: 10.1186/s13053-026-00347-w. Online ahead of print.
- Individual participant dataSharing planned: Yes. Anonymised data can be applied for via the Data Access Committee.
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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.
Rosalind A Eeles, FRCP, FRFR principal investigator
Institute of Cancer Research and Royal Marsden Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Institute of Cancer Research, United Kingdom at 1 site in United Kingdom.
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 4 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: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. 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 Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
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?
Association of SNP genetic risk score with prostate biopsy results. (time frame: 5 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 NCT03857477, 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 27 Oct 2026; AzTrials last refreshed its copy on 1 Nov 2026.