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The PROFILE Study: Germline Genetic Profiling: Correlation With Targeted Prostate Cancer Screening and Treatment (PROFILE)

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ClinicalTrials.gov Identifier: NCT02543905
Recruitment Status : Recruiting
First Posted : September 7, 2015
Last Update Posted : September 14, 2017
Sponsor:
Collaborators:
Royal Marsden NHS Foundation Trust
University of Cambridge
University of Oxford
Queen Mary University of London
Information provided by (Responsible Party):
Institute of Cancer Research, United Kingdom

Brief Summary:

Prostate cancer is the most common cancer in men in the United Kingdom (UK) with over 40,000 men diagnosed each year. Prostate cancer (PrCa) can run in some families and research studies have identified several genetic changes that are thought to increase the risk of developing prostate cancer. This study aims to look at the potential risk of these changes in targeted screening. Some of these changes may cause a very slight increase in prostate cancer risk while others may cause a much larger increase in risk of developing prostate cancer. The investigators will invite men with a family history of prostate cancer for targeted prostate screening (Prostate Specific Antigen (PSA) testing and a biopsy of the prostate gland) and genetic profiling. This research will help us to determine what the risk of cancer is for men who have inherited these genetic changes and also increase our knowledge about the role of genetics in developing prostate cancer targeted screening. Some of these changes may cause a very slight increase in prostate cancer risk while others may cause a much larger increase in risk of developing prostate cancer.

The investigators will invite men with a family history of prostate cancer for targeted prostate screening (PSA testing and a biopsy of the prostate gland) and genetic profiling. This research will help us to determine what the risk of cancer is for men who have inherited these genetic changes and also increase our knowledge about the role of genetics in developing prostate cancer.


Condition or disease Intervention/treatment
Prostate Cancer Prostate Biopsy Genetic Counselling Genetic Markers Procedure: Prostate MRI and Biopsy

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 700 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The PROFILE Study: Germline Genetic Profiling: Correlation With Targeted Prostate Cancer Screening and Treatment
Study Start Date : April 2015
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2025

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Family History Cohort

Men with a family history of prostate cancer defined as:

  • Men with a first degree relative (or second degree if through female line) with histologically or death certificate proven PrCa diagnosed at <70 years
  • Men with two relatives on the same side of the family with histologically or death certificate proven PrCa where at least one is diagnosed at <70 years
  • Men with three relatives on the same side of the family with histologically or death certificate proven PrCa diagnosed at any age
Procedure: Prostate MRI and Biopsy
All men will undergo a MRI and prostate biopsy

Black African / Black Caribbean Cohort
Both parents and all 4 grandparents from that origin
Procedure: Prostate MRI and Biopsy
All men will undergo a MRI and prostate biopsy




Primary Outcome Measures :
  1. The association of specific genetic profiles and biomarkers to predict outcome of prostate screening in men at higher genetic risk [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. The incidence and aggressiveness of prostate cancer in men at higher genetic risk. [ Time Frame: 5 years ]
  2. The association of Diffusion Weighted MRI (DW-MRI) findings with prostate biopsy results. [ Time Frame: 5 years ]
  3. The incidence of abnormal imaging (using 3D ultrasound combined with shear wave elastography) and correlation with biopsy outcome. [ Time Frame: 5 years ]
  4. The association of biological sample biomarker profiles with prostate biopsy result [ Time Frame: 5 years ]
  5. The association of quantitative imaging biomarkers with prostate biopsy result [ Time Frame: 5 years ]

Biospecimen Retention:   Samples With DNA
Serum, plasma, urine, DNA, RNA


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
350 men in each cohort
Criteria

Inclusion Criteria:

Men with either:

  1. A positive family history of PrCa defined as:

    • Men with a first degree relative (or second degree if through female line) with histologically or death certificate proven PrCa diagnosed at <70 years
    • Men with two relatives on the same side of the family with histologically or death certificate proven PrCa where at least one is diagnosed at <70 years
    • Men with three relatives on the same side of the family with histologically or death certificate proven PrCa diagnosed at any age
  2. Of African or Caribbean ancestry defined as:

Both parents and all 4 grandparents from that origin

  • Age 40- 69 years
  • WHO performance status 02 (see Appendix A)
  • Absence of any psychological, familial, sociological or geographical situation potentially hampering compliance with the study protocol and follow up schedule.

Exclusion Criteria:

  • Previous cancer with a life expectancy of less than five years.
  • Previous PrCa
  • Negative biopsy within one year before recruitment
  • Comorbidities making prostate biopsy risk unacceptable (Warfarin or Clopidogrel).
  • Contraindications to having an MRI (pacemakers, aneurysm clips, claustrophobia)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02543905


Contacts
Contact: Elizabeth K Bancroft, PhD 44 207 808 2136 elizabeth.bancroft@icr.ac.uk
Contact: Eva McGrowder, PhD 44 208 722 4483 eva.mcgrowder@icr.ac.uk

Locations
United Kingdom
Institute of Cancer Research and Royal Marsden Hospital Recruiting
Sutton, Surrey, United Kingdom, SM2 5PT
Contact: Rosalind A Eeles, FRCP FRFR    02086613642    rosalind.eeles@icr.ac.uk   
Principal Investigator: Rosalind A Eeles, FRCP FRCR         
Sponsors and Collaborators
Institute of Cancer Research, United Kingdom
Royal Marsden NHS Foundation Trust
University of Cambridge
University of Oxford
Queen Mary University of London

Responsible Party: Institute of Cancer Research, United Kingdom
ClinicalTrials.gov Identifier: NCT02543905     History of Changes
Other Study ID Numbers: CCR4045
First Posted: September 7, 2015    Key Record Dates
Last Update Posted: September 14, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymised data can be applied for via the Data Access Committee

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases