Prostate CancerNCT00959023
Study of Blood and Tumor Samples From Men With an Inherited Risk of Prostate Cancer
An observational study of Prostate Cancer, run by Institute of Cancer Research, United Kingdom at 135 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- laboratory biomarker analysis, medical chart review and questionnaire administration
- How many people
- 21,000 participants
- Where
- 135 sitesUnited Kingdom
- Study dates
- Jun 1993to not given
- Phase
- Observational
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
135 sites in 1 country.
135 sites in 1 country
United Kingdom135 sites, 135 recruiting
- Recruiting
Aberdeen Royal Infirmary
Aberdeen, Scotland, AB25 2ZN
Contact Person, 44-84-5456-6000
- Recruiting
William Harvey Hospital
Ashford-Kent, England, TN24 0LZ
Contact Person, 44-1233-633-331
- Recruiting
Tameside General Hospital
Ashton-under-Lyne, England, OL6 9RW
Contact Person, 44-161-331-6000
- Recruiting
Stoke Mandeville Hospital
Aylesbury-Buckinghamshire, England, HP21 8AL
Contact Person, 44-1296-315-000
- Recruiting
Ayr Hospital
Ayr, Scotland, KA6 6DX
Contact Person, 44-1292-610-555
- Recruiting
North Devon District Hospital
Barnstaple, England, EX31 4JB
Contact Person, 44-1271-322-577
- Recruiting
Furness General Hospital
Barrow in Furness, England, LA14 4LF
Contact Person, 44-1229-870-870
- Recruiting
Basildon University Hospital
Basildon, England, SS16 5NL
Contact Person, 44-1268-533-911
- Recruiting
Basingstoke and North Hampshire NHS Foundation Trust
Basingstoke, England, RG24 9NA
Contact Person, 44-125-631-4793
- Recruiting
Royal United Hospital
Bath, England, BA1 3NG
Contact Person, 44-1-225-824-042
- Recruiting
Primrose Centre at Bedford Hospitals NHS Trust
Bedford, England, MK42 9DJ
Contact Person, 44-123-435-5122
- Recruiting
Belfast City Hospital Trust Incorporating Belvoir Park Hospital
Belfast, Northern Ireland, BT8 8JR
Contact Person, 44-2890-699-069
- Recruiting
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
Birmingham, England, B15 2TH
Contact Person, 44-121-472-1311
- Recruiting
City Hospital - Birmingham
Birmingham, England, B18 7QH
Contact Person, 44-121-554-3801
- Recruiting
Good Hope Hospital
Birmingham, England, B75 7RR
Contact Person, 44-121-424-2000
- Recruiting
Birmingham Heartlands Hospital
Birmingham, England, B9 5SS
Contact Person, 44-121-424-2000
- Recruiting
Royal Blackburn Hospital
Blackburn, England, BB2 3 HH
Contact Person, 44-1254-263-555
- Recruiting
Blackpool Victoria Hospital
Blackpool, England, FY3 8NR
Contact Person, 44-20-7210-4850
- Recruiting
Pilgrim Hospital
Boston, England, PE21 9QT
Contact Person, 44-1205-364-801
- Recruiting
Royal Bournemouth Hospital
Bournemouth, England, BH7 7DW
Contact Person, 44-202-303-626
- Recruiting
Princess of Wales Hospital
Bridgend, Wales, CF31 1JP
Contact Person, 44-1656-752-752
- Recruiting
Sussex Cancer Centre at Royal Sussex County Hospital
Brighton, England, BN2 5BE
Contact Person, 44-12-7369-6955
- Recruiting
Southmead Hospital
Bristol, England, BS10 5NB
Contact Person, 44-117-950-5050
- Recruiting
Frenchay Hospital
Bristol, England, BS16 1LE
Contact Person, 44-117-970-1212
- Recruiting
Bristol Royal Infirmary
Bristol, England, BS2 8HW
Contact Person, 44-117-923-0000
- Recruiting
Broomfield Hospital
Broomfield, England, CM1 7ET
Contact Person, 44-124-551-6339
- Recruiting
Burnley General Hospital
Burnley, England, BB10 2PQ
Contact Person, 44-128-242-5071
- Recruiting
Queen's Hospital
Burton-on-Trent, England, DE13 0RB
Contact Person, 44-1283-566-333
- Recruiting
Addenbrooke's Hospital
Cambridge, England, CB2 2QQ
Contact Person, 44-1223-245-151
- Recruiting
Kent and Canterbury Hospital
Canterbury, England, CT1 3NG
Contact Person, 44-1227-766-877
- Recruiting
Velindre Cancer Center at Velindre Hospital
Cardiff, Wales, CF14 2TL
Contact Person, 44-29-2031-6292
- Recruiting
University Hospital of Wales
Cardiff, Wales, CF14 4XW
Contact Person, 44-29-2074-7747
- Recruiting
St. Helier Hospital
Carshalton, England, SM5 1AA
Contact Person, 44-20-8296-2000
- Recruiting
Countess of Chester Hospital
Chester, England, CH2 1UL
Contact Person, 44-1244-365-000
- Recruiting
Colchester General Hospital
Colchester, England, CO4 5JL
Contact Person, 44-1206-747-474
- Recruiting
Castle Hill Hospital
Cottingham, England, HU16 5JQ
Contact Person, 44-1482-659-331
- Recruiting
Walsgrave Hospital
Coventry, England, CV2 2DX
Contact Person, 44-24-7660-2020
- Recruiting
Mid Cheshire Hospitals Trust- Leighton Hopsital
Crewe, England, CW1 4QJ
Contact Person, 44-1270-255-141
- Recruiting
Mayday University Hospital
Croydon, England
Contact Person, 44-20-8401-3000
- Recruiting
Darent Valley Hospital
Dartford Kent, England, DA2 8DA
Contact Person, 44-1322-428-500
- Recruiting
Derbyshire Royal Infirmary
Derby, England, DE1 2QY
Contact Person, 44-1332-347-141 ext. 2407
- Recruiting
Royal Derby Hospital
Derby, England, DE22 3NE
Contact Person, 44-1332-340-131
- Recruiting
Dorset County Hospital
Dorchester, England, DT1 2JY
Contact Person, 44-1305-251-150
- Recruiting
Downe Hospital
Downpatrick, Northern Ireland, BT30 6JA
Contact Person, 44-28-4461-3311
- Recruiting
Russells Hall Hospital
Dudley, England, DY1 2HQ
Contact Person, 44-1384-456-111
- Recruiting
Eastbourne District General Hospital
Eastbourne, England, BN21 2UD
Contact Person, 44-1323-417-400
- Recruiting
Birmingham Women's Hospital
Edgbaston, England, B15 2TG
Contact Person, 44-121-472-1377
- Recruiting
Epsom General Hospital
Epsom, Surrey, England, KT18 7EG
Contact Person, 44-1372-735-735
- Recruiting
Royal Devon and Exeter Hospital
Exeter, England, EX2 5DW
Contact Person, 44-1392-411-611
- Recruiting
Falkirk and District Royal Infirmary
Falkirk, Scotland, FK1 5QE
Contact Person, 44-1324-624-000
- Recruiting
Royal Bolton Hospital
Farnworth, England, BL4 0JR
Contact Person, 44-120-439-0390
- Recruiting
Frimley Park Hospital
Frimley, England, GU16 7UJ
Contact Person, 44-1276-604-604
- Recruiting
Western Infirmary
Glasgow, Scotland, G11 6NT
Contact Person, 44-141-211-2000
- Recruiting
Grantham and District Hospital
Grantham, Lincolnshire, England, NG31 8DG
Contact Person, 44-1476-565-232
- Recruiting
Diana Princess of Wales Hospital
Grimsby, England, DN33 2BA
Contact Person, 44-147-287-4111
- Recruiting
Harrogate District Hospital
Harrogate, England, HG2 7SX
Contact Person, 44-1423-885-959
- Recruiting
Wycombe General Hospital
High Wycombe, England
Contact Person, 44-1494-526-161
- Recruiting
Princess Royal Hospital at Hull and East Yorkshire NHS Trust
Hull, England, HU8 9HE
Contact Person, 44-1482-701-151
- Recruiting
Ipswich Hospital
Ipswich, England, IP4 5PD
Contact Person, 44-1473-712-233
- Recruiting
Kidderminster Hospital
Kidderminster Worcestershire, England, DY11 6RJ
Contact Person, 44-190-576-0635
- Recruiting
Royal Albert Edward Infirmary
Lancanshire, England, WN1 2NN
Contact Person, 44-1942-244-000
- Recruiting
Royal Lancaster Infirmary
Lancaster, England, LA1 4RP
Contact Person, 44-1524-659-44
- Recruiting
Leeds General Infirmary
Leeds, England, LS1 3EX
Contact Person, 44-113-243-2799
- Recruiting
Cookridge Hospital
Leeds, England, LS16 6QB
Contact Person, 44-113-267-3411
- Recruiting
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, LS9 7TF
Contact Person, 44-113-206-6400
- Recruiting
Leicester Royal Infirmary
Leicester, England, LE1 5WW
Contact Person, 44-116-254-1414
- Recruiting
Leicester General Hospital
Leicester, England, LE5 4PW
Contact Person, 44-116-249-0490
- Recruiting
Lincoln County Hospital
Lincoln, England, LN2 5QY
Contact Person, 44-1522-573-965
- Recruiting
Royal Liverpool University Hospital
Liverpool, England, L7 8XP
Contact Person, 44-151-706-2000
- Recruiting
Royal London Hospital
London, England, E1 1BB
Contact Person, 44-20-7377-7000
- Recruiting
Whipps Cross Hospital
London, England, E11 1NR
Contact Person, 44-20-8539-5522
- Recruiting
Saint Bartholomew's Hospital
London, England, EC1A 7BE
Contact Person, 44-20-7601-8391
- Recruiting
Guy's Hospital
London, England, SE1 9RT
Contact Person, 44-20-7188-7188
- Recruiting
Hammersmith Hospital
London, England, W12 OHS
Contact Person, 44-20-8383-1000
- Recruiting
Middlesex Hospital
London, England, W1T 3AA
Contact Person, 44-845-1555-000
- Recruiting
St. Mary's Hospital
London, England, W2 1NY
Contact Person, 44-20-7886- 6666
- Recruiting
Charing Cross Hospital
London, England, W6 8RF
Contact Person, 44-20-8846-1234
- Recruiting
Altnagelvin Area Hospital
Londonderry, Northern Ireland, BT47 1SB
Contact Person, 44-1504-45-171
- Recruiting
Macclesfield District General Hospital
Macclesfield, England, SK10 3BL
Contact Person, 44-1625-421-000
- Recruiting
Maidstone Hospital
Maidstone, England, ME16 9QQ
Contact Person, 44-1622-729-000
- Recruiting
Christie Hospital
Manchester, England, M20 4BX
Contact Person, 44-845-226-3000
- Recruiting
Clatterbridge Centre for Oncology
Merseyside, England, CH63 4JY
Contact Person, 44-151-334-1155
- Recruiting
James Cook University Hospital
Middlesbrough, England, TS4 3BW
Contact Person, 44-1642-850-850
- Recruiting
Milton Keynes General Hospital
Milton Keynes, England, MK6 5LD
Contact Person, 44-1908-660-033
- Recruiting
Queen Victoria Hospital
Morecambe, LA4 5NN
Contact Person, 44-1524-405-700
- Recruiting
Newcastle Upon Tyne Hospitals NHS Trust
Newcastle upon Tyne, England, NE7 7DN
Contact Person, 44-191-232-5131
- Recruiting
Royal Gwent Hospital
Newport Gwent, Wales, NP9 2UB
Contact Person, 44-1633-234-234
- Recruiting
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, England, HA6 2RN
Contact Person, 44-1923-826-111
- Recruiting
Norfolk and Norwich University Hospital
Norwich, England, NR4 7UY
Contact Person, 44-603-286-286
- Recruiting
Nottingham City Hospital
Nottingham, England, NG5 1PB
Contact Person, 44-115-969-1169
- Recruiting
Kings Mill Hospital
Nottinghamshire, England, NG17 4JL
Contact Person, 44-162-362-2515
- Recruiting
George Eliot Hospital
Nuneaton, England, CV10 7DJ
Contact Person, 44-24-7635-1351
- Recruiting
Churchill Hospital
Oxford, England, OX3 7LJ
Contact Person, 44-186-574-1841
- Recruiting
Peterborough Hospitals Trust
Peterborough, England, PE3 6DA
Contact Person, 44-1733-874-510
- Recruiting
Edith Cavell Hospital
Peterborough, PE3 9GZ
Contact Person, 44-1733-874-000
- Recruiting
Derriford Hospital
Plymouth, England, PL6 8DH
Contact Person, 44-175-277-7111
- Recruiting
Dorset Cancer Centre
Poole Dorset, England, BH15 2JB
Contact Person, 44-1202-448-263
- Recruiting
Craigavon Area Hospital
Portadown, Craigavon, Northern Ireland, BT63 5QQ
Contact Person, 44-28-3833-4444
- Recruiting
Rosemere Cancer Centre at Royal Preston Hospital
Preston, England, PR2 9HT
Contact Person, 44-1772-710-089
- Recruiting
Berkshire Cancer Centre at Royal Berkshire Hospital
Reading, England, RG1 5AN
Contact Person, 44-118-322-7878
- Recruiting
Alexandra Healthcare NHS
Redditch, Worcestershire, England, B98 7UB
Contact Person, 44-015-2750-3030
- Recruiting
Glan Clwyd Hospital
Rhyl, Denbighshire, Wales, LL 18 5UJ
Contact Person, 44-1745-583-910
- Recruiting
Queens Hospital
Romford, England, RM3 0BE
Contact Person, 44-170-834-5533
- Recruiting
Conquest Hospital
Saint Leonards-on-Sea, England, TN37 7RD
Contact Person, 44-1424-755-255
- Recruiting
Hope Hospital
Salford, England, M6 8HD
Contact Person, 44-161-789-7373
- Recruiting
Salisbury District Hospital
Salisbury, England, SP2 8BJ
Contact Person, 44-1722-336-262
- Recruiting
Scarborough General Hospital
Scarborough, England, YO12 6QL
Contact Person, 44-1723-368-111
- Recruiting
Scunthorpe General Hospital
Scunthorpe, England, DN15 7BH
Contact Person, 44-172-428-2282
- Recruiting
Southlands Hospital
Shoreham-by-Sea, BN43 6TQ
Contact Person, 44-1903-205-111
- Recruiting
Royal Shrewsbury Hospital
Shrewsbury, England, SY3 8XQ
Contact Person, 44-1743-261-000
- Recruiting
Wexham Park Hospital
Slough, Berkshire, England, SL2 4HL
Contact Person, 44-1753-633-000
- Recruiting
Solihull Hospital
Solihull, England, B91 2JL
Contact Person, 44-121-424-2000
- Recruiting
Southampton General Hospital
Southampton, England, SO16 6YD
Contact Person, 44-23-8079-8751
- Recruiting
Princess Anne Hospital
Southampton, SO16 5YA
Contact Person, 44-23-8077-7222
- Recruiting
Southport and Formby District General Hospital
Southport, England, PR8 6PN
Contact Person, 44-1704-547-471
- Recruiting
Staffordshire General Hospital
Stafford, England, ST16 3SA
Contact Person, 44-178-525-7731
- Recruiting
Lister Hospital
Stevenage, England, SG1 4AB
Contact Person, 44-1438-314-333
- Recruiting
Stirling Royal Infirmary
Stirling, England, FK8 2AU
Contact Person, 44-1786-434-000
- Recruiting
Stepping Hill Hospital
Stockport, England, SK2 7JE
Contact Person, 44-161-483-1010
- Recruiting
Kingston Hospital
Surrey, England, KT2 7QB
Contact Person, 44-20-8546-7711
- Recruiting
East Surrey Hospital
Surrey, England, RH1 5RH
Contact Person, 44-1737-768-511
- Recruiting
Royal Marsden - Surrey
Sutton, England, SM2 5PT
Contact Person, 44-20-8642-6011
- Recruiting
Singleton Hospital
Swansea, Wales, SA2 8QA
Contact Person, 44-1792-285-501
- Recruiting
Great Western Hospital
Swindon, England, SN3 6BB
Contact Person, 44-1793-604-020
- Recruiting
Taunton and Somerset Hospital
Taunton, England, TA1 5DA
Contact Person, 44-1823-333-444
- Recruiting
Torbay Hospital
Torquay, England, TQ2 7AA
Contact Person, 44-1803-614-567
- Recruiting
Hillingdon Hospital
Uxbridge, England, UB8 3NN
Contact Person, 44-1895-238-282
- Recruiting
Pinderfields General Hospital
Wakefield, Scotland, WF1 4DG
Contact Person, 44-84-4811-8110
- Recruiting
Warwick Hospital
Warwick, England, CV34 5BW
Contact Person, 44-1926-495-321
- Recruiting
Sandwell General Hospital
West Bromwich, England, B71 4HJ
Contact Person, 44-21-553-1831 ext. 3817
- Recruiting
Southend University Hospital NHS Foundation Trust
Westcliff-on-Sea, England, SS0 0RY
Contact Person, 44-1702-435-555
- Recruiting
New Cross Hospital
Wolverhampton, England, WV10 0QP
Contact Person, 44-190-230-7999
- Recruiting
Worthing Hospital
Worthing, England, BN11 2DH
Contact Person, 44-1903-205-111
- Recruiting
Yeovil District Hospital
Yeovil, England, BA21 4AT
Contact Person, 44-1935-475-122
- Recruiting
Cancer Care Centre at York Hospital
York, England, Y031 8HE
Contact Person, 44-1904-726-931
About this study
Official title: UK Genetic Prostate Cancer Study
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.
Read the detailed 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.
- Conditions
- Prostate Cancer
- Being tested
- laboratory biomarker analysis, medical chart review, questionnaire administration
- Keywords
- stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer, recurrent 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.
laboratory biomarker analysisOther
medical chart reviewOther
questionnaire administrationOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Prostate cancer (PC) predisposition (PCP) genes
Secondary outcomes (7)
Association of PCP genes with disease and treatment parameters
Association of PCP with environmental factors
Family history of PC
Relative risk of developing PC
Increased risk relatives of PC patients are to develop cancers other than PC
Markers of PC that are associated with PCP genes
Specific tumor genetic profile correlated with PCP genes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2009 (estimated)
- Study startJun 1993
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Enrolment
- 21,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Cancer Research, United Kingdom
- Sponsor type
- University, hospital or other
- Investigators
- Rosalind Eeles, PhD, FRCR, FRCP, FMed Sci, Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00959023
- Sponsor's protocol ID
- CDR0000636371
- Other IDs
- ICR-UKGPCS, EU-20909
- Status last verified
- Aug 2009
- First submitted
- 13 Aug 2009
- Last updated
- 26 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UK Genetic Prostate Cancer Study
- ClinicalTrials.gov ID
- NCT00959023
- Acronym / sponsor ID
- CDR0000636371
- Conditions
- Prostate Cancer
- Keywords
- stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer, recurrent prostate cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 21,000 participants (estimated)
- Lead sponsor
- Institute of Cancer Research, United KingdomUniversity, hospital or other
- Study start
- Jun 1993
- First posted
- 14 Aug 2009 (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.
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.
Detailed 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.
Study design
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| laboratory biomarker analysis | Other | – |
| medical chart review | Other | – |
| questionnaire administration | Other | – |
Primary outcome
Prostate cancer (PC) predisposition (PCP) genes
7 secondary outcomes
Association of PCP genes with disease and treatment parameters
Association of PCP with environmental factors
Family history of PC
Relative risk of developing PC
Increased risk relatives of PC patients are to develop cancers other than PC
Markers of PC that are associated with PCP genes
Specific tumor genetic profile correlated with PCP genes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2013.
Related trials for Prostate Cancer
RecruitingObservational study
Imaging Studies to Check the Local Response of Prostate Cancer to Radiation Therapy
Prostatic Neoplasms, Prostate Cancer
Active, not recruitingPhase 2
Study of TGF-β Receptor Inhibitor Galunisertib (LY2157299) and Enzalutamide in Metastatic Castration-resistant Prostate Cancer
Prostate Cancer
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
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 Eeles, PhD, FRCR, FRCP, FMed Sci principal investigator
Royal Marsden NHS Foundation Trust
135 sites 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 135 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 135 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prostate cancer (PC) predisposition (PCP) genes. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Aug 2013; AzTrials last refreshed its copy on 7 Nov 2026.