Study of Blood and Tumor Samples From Men With an Inherited Risk of Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

UK Genetic Prostate Cancer Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00959023
• Other study ID #: CDR0000636371
• Secondary ID: ICR-UKGPCSEU-209
• Status: Recruiting
• Phase: N/A
• First received: August 13, 2009
• Last updated: August 23, 2013
• Start date: June 1993

Study information

• Verified date: August 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Observational

Clinical Trial Summary

RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify genes related to cancer.

PURPOSE: This clinical trial is studying blood and tumor samples from men with an inherited risk of prostate cancer.

Description:

OBJECTIVES:

• To find genes that predispose to prostate cancer (using genetic linkage and other molecular biology techniques).

• To determine if genes that predispose to prostate cancer are associated with disease and treatment parameters.

• To determine if genes that predispose to prostate cancer are associated with environmental factors.

• To estimate the percentage of prostate cancer patients who have a positive family history of the disease.

• To estimate the relative risk of developing prostate cancer in a currently unaffected member of a prostate cancer family.

• To ascertain whether relatives of prostate cancer patients are at increased risk of developing cancers other than prostate cancer.

• To build up a large blood and tumor (both fresh and preserved) bank from patients with prostate cancer to identify prostate cancer predisposition gene(s), determine the prevalence and penetrance of prostate cancer predisposition genes in prostate cancer patients, correlate changes in prostate cancer predisposition gene(s) with disease and treatment parameters by matching with clinical data from clinical databases already held as part of the medical record on these patients, and correlate changes in prostate cancer predisposition gene(s) with environmental factors collected by questionnaire from these patients.

• To use the blood and tumor bank for marker studies (DNA, RNA, serum, plasma, protein, and other molecules) to define the role of these markers in disease prediction and progression.

• To develop microarrays from prostate cancers to determine their genetic profile and correlate this with prostate cancer genetic predisposition genes.

• To collect tissue from other unaffected and affected members of the family in cases where a genetic alteration is found, in order to ascertain whether this alteration is associated with disease risk.

• To collect tissue samples from unaffected family members who show an interest in taking part in the study.

OUTLINE: Patients are assessed by a family history and epidemiology questionnaire and undergo a medical record review.

Patients and relatives with prostate cancer may undergo blood sample collection for genetic analysis of prostate cancer predisposition genes and measurement of markers of associations with genetic changes associated with prostate cancer. Blood and tumor samples are stored for future studies.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 21000
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

DISEASE CHARACTERISTICS:

• Meets 1 of the following criteria:

• Diagnosis of prostate cancer meeting any of the following criteria:

• Attending prostate clinics at The Royal Marsden NHS Foundation Trust

• Any age at diagnosis

• Not attending prostate clinics at The Royal Marsden NHS Foundation Trust, meeting 1 of the following criteria:

• No older than 60 years at diagnosis

• Diagnosis in two relatives where one is = 65 years at diagnosis

• At any age in a cluster with 3 or more cases

• Any unaffected male relatives of men who are already taking part in the study

PATIENT CHARACTERISTICS:

• Able to understand the information sheet and give informed consent

• No man who is too ill to take part

PRIOR CONCURRENT THERAPY:

• Not specified

Study Design

N/A

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• laboratory biomarker analysis

• medical chart review

• questionnaire administration

Locations

Country	Name	City	State
United Kingdom	Aberdeen Royal Infirmary	Aberdeen	Scotland
United Kingdom	William Harvey Hospital	Ashford-Kent	England
United Kingdom	Tameside General Hospital	Ashton-Under-Lyne	England
United Kingdom	Stoke Mandeville Hospital	Aylesbury-Buckinghamshire	England
United Kingdom	Ayr Hospital	Ayr	Scotland
United Kingdom	North Devon District Hospital	Barnstaple	England
United Kingdom	Furness General Hospital	Barrow in Furness	England
United Kingdom	Basildon University Hospital	Basildon	England
United Kingdom	Basingstoke and North Hampshire NHS Foundation Trust	Basingstoke	England
United Kingdom	Royal United Hospital	Bath	England
United Kingdom	Primrose Centre at Bedford Hospitals NHS Trust	Bedford	England
United Kingdom	Belfast City Hospital Trust Incorporating Belvoir Park Hospital	Belfast	Northern Ireland
United Kingdom	Birmingham Heartlands Hospital	Birmingham	England
United Kingdom	City Hospital - Birmingham	Birmingham	England
United Kingdom	Good Hope Hospital	Birmingham	England
United Kingdom	Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust	Birmingham	England
United Kingdom	Royal Blackburn Hospital	Blackburn	England
United Kingdom	Blackpool Victoria Hospital	Blackpool	England
United Kingdom	Pilgrim Hospital	Boston	England
United Kingdom	Royal Bournemouth Hospital	Bournemouth	England
United Kingdom	Princess of Wales Hospital	Bridgend	Wales
United Kingdom	Sussex Cancer Centre at Royal Sussex County Hospital	Brighton	England
United Kingdom	Bristol Royal Infirmary	Bristol	England
United Kingdom	Frenchay Hospital	Bristol	England
United Kingdom	Southmead Hospital	Bristol	England
United Kingdom	Broomfield Hospital	Broomfield	England
United Kingdom	Burnley General Hospital	Burnley	England
United Kingdom	Queen's Hospital	Burton-upon-Trent	England
United Kingdom	Addenbrooke's Hospital	Cambridge	England
United Kingdom	Kent and Canterbury Hospital	Canterbury	England
United Kingdom	University Hospital of Wales	Cardiff	Wales
United Kingdom	Velindre Cancer Center at Velindre Hospital	Cardiff	Wales
United Kingdom	St. Helier Hospital	Carshalton	England
United Kingdom	Countess of Chester Hospital	Chester	England
United Kingdom	Colchester General Hospital	Colchester	England
United Kingdom	Castle Hill Hospital	Cottingham	England
United Kingdom	Walsgrave Hospital	Coventry	England
United Kingdom	Mid Cheshire Hospitals Trust- Leighton Hopsital	Crewe	England
United Kingdom	Mayday University Hospital	Croydon	England
United Kingdom	Darent Valley Hospital	Dartford Kent	England
United Kingdom	Derbyshire Royal Infirmary	Derby	England
United Kingdom	Royal Derby Hospital	Derby	England
United Kingdom	Dorset County Hospital	Dorchester	England
United Kingdom	Downe Hospital	Downpatrick	Northern Ireland
United Kingdom	Russells Hall Hospital	Dudley	England
United Kingdom	Eastbourne District General Hospital	Eastbourne	England
United Kingdom	Birmingham Women's Hospital	Edgbaston	England
United Kingdom	Epsom General Hospital	Epsom, Surrey	England
United Kingdom	Royal Devon and Exeter Hospital	Exeter	England
United Kingdom	Falkirk and District Royal Infirmary	Falkirk	Scotland
United Kingdom	Royal Bolton Hospital	Farnworth	England
United Kingdom	Frimley Park Hospital	Frimley	England
United Kingdom	Western Infirmary	Glasgow	Scotland
United Kingdom	Grantham and District Hospital	Grantham, Lincolnshire	England
United Kingdom	Diana Princess of Wales Hospital	Grimsby	England
United Kingdom	Harrogate District Hospital	Harrogate	England
United Kingdom	Wycombe General Hospital	High Wycombe	England
United Kingdom	Princess Royal Hospital at Hull and East Yorkshire NHS Trust	Hull	England
United Kingdom	Ipswich Hospital	Ipswich	England
United Kingdom	Kidderminster Hospital	Kidderminster Worcestershire	England
United Kingdom	Royal Albert Edward Infirmary	Lancanshire	England
United Kingdom	Royal Lancaster Infirmary	Lancaster	England
United Kingdom	Cookridge Hospital	Leeds	England
United Kingdom	Leeds Cancer Centre at St. James's University Hospital	Leeds	England
United Kingdom	Leeds General Infirmary	Leeds	England
United Kingdom	Leicester General Hospital	Leicester	England
United Kingdom	Leicester Royal Infirmary	Leicester	England
United Kingdom	Lincoln County Hospital	Lincoln	England
United Kingdom	Royal Liverpool University Hospital	Liverpool	England
United Kingdom	Charing Cross Hospital	London	England
United Kingdom	Guy's Hospital	London	England
United Kingdom	Hammersmith Hospital	London	England
United Kingdom	Middlesex Hospital	London	England
United Kingdom	Royal London Hospital	London	England
United Kingdom	Saint Bartholomew's Hospital	London	England
United Kingdom	St. Mary's Hospital	London	England
United Kingdom	Whipps Cross Hospital	London	England
United Kingdom	Altnagelvin Area Hospital	Londonderry	Northern Ireland
United Kingdom	Macclesfield District General Hospital	Macclesfield	England
United Kingdom	Maidstone Hospital	Maidstone	England
United Kingdom	Christie Hospital	Manchester	England
United Kingdom	Clatterbridge Centre for Oncology	Merseyside	England
United Kingdom	James Cook University Hospital	Middlesbrough	England
United Kingdom	Milton Keynes General Hospital	Milton Keynes	England
United Kingdom	Queen Victoria Hospital	Morecambe
United Kingdom	Newcastle Upon Tyne Hospitals NHS Trust	Newcastle-Upon-Tyne	England
United Kingdom	Royal Gwent Hospital	Newport Gwent	Wales
United Kingdom	Mount Vernon Cancer Centre at Mount Vernon Hospital	Northwood	England
United Kingdom	Norfolk and Norwich University Hospital	Norwich	England
United Kingdom	Nottingham City Hospital	Nottingham	England
United Kingdom	Kings Mill Hospital	Nottinghamshire	England
United Kingdom	George Eliot Hospital	Nuneaton	England
United Kingdom	Churchill Hospital	Oxford	England
United Kingdom	Edith Cavell Hospital	Peterborough
United Kingdom	Peterborough Hospitals Trust	Peterborough	England
United Kingdom	Derriford Hospital	Plymouth	England
United Kingdom	Dorset Cancer Centre	Poole Dorset	England
United Kingdom	Craigavon Area Hospital	Portadown, Craigavon	Northern Ireland
United Kingdom	Rosemere Cancer Centre at Royal Preston Hospital	Preston	England
United Kingdom	Berkshire Cancer Centre at Royal Berkshire Hospital	Reading	England
United Kingdom	Alexandra Healthcare NHS	Redditch, Worcestershire	England
United Kingdom	Glan Clwyd Hospital	Rhyl, Denbighshire	Wales
United Kingdom	Queens Hospital	Romford	England
United Kingdom	Conquest Hospital	Saint Leonards-on-Sea	England
United Kingdom	Hope Hospital	Salford	England
United Kingdom	Salisbury District Hospital	Salisbury	England
United Kingdom	Scarborough General Hospital	Scarborough	England
United Kingdom	Scunthorpe General Hospital	Scunthorpe	England
United Kingdom	Southlands Hospital	Shoreham-by-Sea
United Kingdom	Royal Shrewsbury Hospital	Shrewsbury	England
United Kingdom	Wexham Park Hospital	Slough, Berkshire	England
United Kingdom	Solihull Hospital	Solihull	England
United Kingdom	Princess Anne Hospital	Southampton
United Kingdom	Southampton General Hospital	Southampton	England
United Kingdom	Southport and Formby District General Hospital	Southport	England
United Kingdom	Staffordshire General Hospital	Stafford	England
United Kingdom	Lister Hospital	Stevenage	England
United Kingdom	Stirling Royal Infirmary	Stirling	England
United Kingdom	Stepping Hill Hospital	Stockport	England
United Kingdom	East Surrey Hospital	Surrey	England
United Kingdom	Kingston Hospital	Surrey	England
United Kingdom	Royal Marsden - Surrey	Sutton	England
United Kingdom	Singleton Hospital	Swansea	Wales
United Kingdom	Great Western Hospital	Swindon	England
United Kingdom	Taunton and Somerset Hospital	Taunton	England
United Kingdom	Torbay Hospital	Torquay	England
United Kingdom	Hillingdon Hospital	Uxbridge	England
United Kingdom	Pinderfields General Hospital	Wakefield	Scotland
United Kingdom	Warwick Hospital	Warwick	England
United Kingdom	Sandwell General Hospital	West Bromwich	England
United Kingdom	Southend University Hospital NHS Foundation Trust	Westcliff-On-Sea	England
United Kingdom	New Cross Hospital	Wolverhampton	England
United Kingdom	Worthing Hospital	Worthing	England
United Kingdom	Yeovil District Hospital	Yeovil	England
United Kingdom	Cancer Care Centre at York Hospital	York	England

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	Prostate cancer (PC) predisposition (PCP) genes			No
Secondary	Association of PCP genes with disease and treatment parameters			No
Secondary	Association of PCP with environmental factors			No
Secondary	Family history of PC			No
Secondary	Relative risk of developing PC			No
Secondary	Increased risk relatives of PC patients are to develop cancers other than PC			No
Secondary	Markers of PC that are associated with PCP genes			No
Secondary	Specific tumor genetic profile correlated with PCP genes			No