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Study Summary
No. 2007-0938:.......Prostate......Sara Strom......Epidemiology
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Study Summary Title
Study Summary
Number:
2007-0938
Study Title:Identification of Men with a Genetic Predisposition to Prostate Cancer: Targeted Screening in BRCA1/2 Mutation Carriers and Controls
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Physician New Patient Referral
Name:Sara StromPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:EpidemiologyReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-3020
Contact us about clinical trials
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General Information
Disease Group:ProstateSupported By:Institute of Cancer Research
Kadoorie Foundation
Phase of Study:N/AReturn
Visit:
At a minimum, subjects will come to MDACC for an annual PSA exam.
Treatment
Agents:
NoneHome Care:None.
Treatment Loc:Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions
Estimated
Length of Stay
in Houston:
None.
Description/
Intervention:
The goal of this research study is to look at ways doctors can find prostate
cancer early for men with the BRCA1 or BRCA2 alteration, compared with a group
of men without the alteration. This study will also study the risk of prostate
cancer for men with the BRCA1 or BRCA2 alteration. Researchers will also study
the biological differences between men with the BRCA1 or BRCA2 alteration and
men without it.
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Study Objectives / Outcomes
The objectives of this study are:
  • To establish an international targeted prostate screening study in BRCA1 and BRCA2 carriers and men with a negative BRCA1 or BRCA2 test where biological samples can be taken and assessed in this cohort.
  • To determine the incidence of raised PSA and abnormal biopsy as a result of PSA screening in this group and determine if the incidence of raised PSA and pathology is different from screen-detected disease in controls who comprise: i) a group of men who are age matched (+/- 5 years) and who have a negative predictive genetic test, ii) two population based screening studies.
  • To determine the sensitivity and specificity of PSA screening for prostate cancer in male BRCA1/2 gene mutation carriers and controls.
  • To prospectively collect serial serum and urine samples to evaluate new markers of early prostate cancer in BRCA1/2 carriers and controls.
  • To gain a better understanding of the pathogenesis of prostate cancer in men with BRCA1 or BRCA 2 mutations. This will be done through further investigation by genomics and post-genomic technologies (including micro-arrays, biochemistry, biological function assays, proteomics, and metabonomics).

The translational research studies aim to:
  • Investigate new serum markers of prostate cancer and of familial predisposition.
  • Study germline and somatic gene expression (blood and tumor RNA studies).
  • Conduct immunophenotyping of prostate cancer specimens to identify histopathology features of BRCA1/2 carriers vs. the control group.
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Study Status Information
Study Activation / Registration Date:07/23/2008
IRB Review and Approval Date:06/16/2008
Study Type:Other
Recruitment Status:Open
Projected Accrual:1700
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:1) Male

2) BRCA1 and BRCA2 mutation status known (i.e., Subject is either carrier of known pathogenic BRCA1 or BRCA 2 mutation OR has tested negative for known BRCA1 and BRCA2 mutation present within their family.)

3) Age 40-69 years

4) WHO performance status 0-2

5) No previous history of prostate cancer

6) No previous prostate biopsy for raised PSA

7) Absence of any psychological, familial, sociological or geographical situation potentially hampering compliance with the study protocol and follow-up schedule.

8) Subject has signed a written informed consent.

Exclusion Criteria:1) Previous cancer with a terminal prognosis of less than 5 years.

2) Previous prostate cancer

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Links
Registration Number: NCT00261456
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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