The BARCODE 1 Study (Full Study): The Use of Genetic Profiling to Guide Prostate Cancer Targeted Screening.

Prostate Cancer Clinical Trial

— BARCODE1  

Official title:

The BARCODE 1 Study: The Use of Genetic Profiling to Guide Prostate Cancer Targeted Screening.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03857477
• Other study ID #: CCR5044
• Status: Active, not recruiting
• Start date: March 14, 2019
• Est. completion date: September 1, 2027

Study information

• Verified date: January 2024
• Source: Institute of Cancer Research, United Kingdom
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. The full study is an extension of the pilot study aiming to recruit a total of 5000 men.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 4700
• Est. completion date: September 1, 2027
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 55 Years to 69 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• 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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Genetic:
• Genetic SNP profiling
Genetic SNP profiling of known prostate cancer predisposition SNPs will be performed on DNA extracted from saliva samples.

Other:
• Prostate cancer screening
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.

Procedure:
• MRI Scan
MRI scan will be offered to men identified within the top 10% genetic risk score profile.
• Prostate biopsy
Transperineal prostate biopsy under local anaesthetic will be offered to men identified within the top 10% genetic risk score profile.

Locations

Country	Name	City	State
United Kingdom	Institute of Cancer Research and Royal Marsden Hospital	Sutton	Surrey

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Cancer Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association of SNP genetic risk score with prostate biopsy results.		5 years
Secondary	Incidence and aggressiveness of PrCa in men within the top 10% of the genetic score.		5 years
Secondary	Association of the biomarker profile with genetic score and biopsy results.		5 years
Secondary	Use of genetic profiling to target prostate cancer screening in a population screening clinical environment.		5 years

External Links

•   WHO Performance Status