<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03805919</url>
  </required_header>
  <id_info>
    <org_study_id>190040</org_study_id>
    <secondary_id>19-C-0040</secondary_id>
    <nct_id>NCT03805919</nct_id>
  </id_info>
  <brief_title>Men at High Genetic Risk for Prostate Cancer</brief_title>
  <official_title>Natural History Study of Men at High Genetic Risk for Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institutes of Health Clinical Center (CC)</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      Research studies have shown that genetic changes and family history may increase a man s risk&#xD;
      for prostate cancer. Researchers want to follow the prostate health of men who have specific&#xD;
      genetic changes associated with prostate cancer to help them learn more about which men are&#xD;
      at higher risk for prostate cancer.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      To study men with specific genetic changes and determine who is at higher risk for getting&#xD;
      prostate cancer. To study if certain genetic changes and family history can be used to help&#xD;
      prevent or treat prostate cancer.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      Persons assigned male at birth ages 30-75 who have one or more specific genetic changes but&#xD;
      without prostate cancer.&#xD;
&#xD;
      Design:&#xD;
&#xD;
        -  This study does not perform genetic testing. All participants must have documented&#xD;
           genetic changes and able to provide a copy of the report.&#xD;
&#xD;
        -  Before enrollment, participants will provide a copy of documented genetic changes and go&#xD;
           through a telephone interview to determine eligibility for the study.&#xD;
&#xD;
        -  On enrollment, participants will have medical and family history review, medication&#xD;
           review, physical exam, blood collection for clinical and research testing, and MRI&#xD;
           (magnetic resonance imaging) of the prostate.&#xD;
&#xD;
        -  Every year, participants will repeat the physical exam, medical history, family history,&#xD;
           medication review, routine blood tests, including PSA and testosterone.&#xD;
&#xD;
        -  Every 2 years, participants will repeat all the above plus prostate MRI and blood tests&#xD;
           for research.&#xD;
&#xD;
        -  If, at any time, the physical exam, blood tests or MRI are abnormal, participants may be&#xD;
           asked to do a biopsy.&#xD;
&#xD;
        -  If the biopsy results in prostate cancer, participants will be given counseling on next&#xD;
           steps, general treatment recommendations, and then followed with a phone call each year.&#xD;
&#xD;
        -  Participants may ask to speak with a genetic counselor.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background:&#xD;
&#xD;
      Prostate cancer is the most common malignancy and the second leading cause of cancer-related&#xD;
      deaths in American men.&#xD;
&#xD;
      Prostate cancer has substantial inherited predisposition and certain genetic variants that&#xD;
      are associated with an increased risk of prostate cancer.&#xD;
&#xD;
      An evolving approach to prostate cancer screening is to target populations at risk of&#xD;
      developing prostate cancer based on their genetic predisposition.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      To follow the natural history of men with known germline variants or likely pathogenic&#xD;
      variants in genes that put them at risk for developing prostate cancer.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      Persons assigned male at birth who are between ages 30-75 years old.&#xD;
&#xD;
      Documented germline pathogenic or likely pathogenic variants in prostate cancer-related risk&#xD;
      gene: BRCA 1 and 2, DNA Mismatch Repair (MMR) genes associated with Lynch syndrome (MLH1,&#xD;
      MSH2, MSH6, PMS2, and EPCAM), HOXB13, ATM, NBN, TP53, CHEK2, PALB2, RAD51C, RAD51D, BRIP1, or&#xD;
      FANC (FANCA, FANCB, FANCC, FANCD2, FANCE, FANCF, FANCG, FANCI, FANCL, and FANCM).&#xD;
&#xD;
      Must be able and willing to provide informed consent.&#xD;
&#xD;
      Design:&#xD;
&#xD;
      Up to 500 subjects will be enrolled.&#xD;
&#xD;
      Participants will undergo sampling of blood for prostate-specific antigen. Based on these&#xD;
      results and age, participants will be considered for biopsy and/or continued monitoring if&#xD;
      feasible upon clinical discretion.&#xD;
&#xD;
      Participants will undergo a baseline MRI evaluation with follow-up scans every 2 years as&#xD;
      clinically indicated.&#xD;
&#xD;
      Following initial evaluation, participants will be followed as clinically indicated, usually&#xD;
      at 12 month intervals, to determine their PSA level, prostate cancer treatment (if relevant)&#xD;
      and/or disease/survival status until death.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 27, 2019</start_date>
  <completion_date type="Anticipated">January 1, 2039</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2029</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Natural history of high genetic risk for prostate cancer</measure>
    <time_frame>one year</time_frame>
    <description>To follow the natural history of men with known germline variants or likely pathogenic variants in genes that put them at high risk for developing prostate cancer</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>mpMRI feasibility</measure>
    <time_frame>baseline and every two years until death or when criteria for removal from study is met</time_frame>
    <description>test the feasibility and accuracy of multi parametric magnetic resonance imaging (mpMRI) for the localization and detection of local prostate cancer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>role of mpMRI</measure>
    <time_frame>baseline and every two years until death or when criteria for removal from study is met</time_frame>
    <description>role of mpMRI in monitoring participants on active surveillance and as a follow up tool for monitoring local disease progression</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Prostatic Neoplasms</condition>
  <arm_group>
    <arm_group_label>Cohort 1</arm_group_label>
    <description>Participants with germline pathogenic or likely pathogenic variants in prostate cancer-related risk genes</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Persons assigned male at birth with a documented germline variant in prostate cancer&#xD;
        risk-related gene from a CLIA certified laboratory&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        -  Inclusion Criteria:&#xD;
&#xD;
          -  Persons assigned male at birth between the ages of 30-75 years.&#xD;
&#xD;
          -  Documented germline variant (i.e. pathogenic/likely pathogenic variant) in prostate&#xD;
             cancer risk-related gene from a CLIA certified laboratory: BRCA1 and BRCA2, MMR genes&#xD;
             (MLH1, MSH2, MSH6, PMS2, and EPCAM) associated with Lynch syndrome, as well as HOXB13,&#xD;
             ATM, NBN, TP53, CHEK2, PALB2, RAD51C, RAD51D, BRIP1, or FANC (FANCA, FANCB, FANCC,&#xD;
             FANCD2, FANCE, FANCF, FANCG, FANCI, FANCL, and FANCM).&#xD;
&#xD;
          -  Prognosis of &gt;5 years survival if affected by another cancer&#xD;
&#xD;
          -  Ability of subject to understand and the willingness to sign a written informed&#xD;
             consent document&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior diagnosis or treatment for prostate cancer&#xD;
&#xD;
          -  Known contraindication to MRI:&#xD;
&#xD;
               -  Participants unable to fit through MRI scanner (radiologist discretion)&#xD;
&#xD;
               -  Allergy to MR contrast agent&#xD;
&#xD;
               -  Participants with pacemakers, cerebral aneurysm clips, shrapnel injury, or&#xD;
                  implantable electronic device&#xD;
&#xD;
          -  Active concomitant medical or psychological illnesses that may increase the risk to&#xD;
             the subject or inability to obtain informed consent, at the discretion of the&#xD;
             principal investigator.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fatima H Karzai, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Cancer Institute (NCI)</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Anna C Couvillon, C.R.N.P.</last_name>
    <phone>(240) 858-3148</phone>
    <email>couvilla@mail.nih.gov</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Fatima H Karzai, M.D.</last_name>
    <phone>(301) 480-7174</phone>
    <email>fatima.karzai@nih.gov</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>National Institutes of Health Clinical Center</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20892</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)</last_name>
      <phone>800-411-1222</phone>
      <phone_ext>TTY dial 711</phone_ext>
      <email>ccopr@nih.gov</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2019-C-0040.html</url>
    <description>NIH Clinical Center Detailed Web Page</description>
  </link>
  <reference>
    <citation>Al Olama AA, Kote-Jarai Z, Berndt SI, Conti DV, Schumacher F, Han Y, Benlloch S, Hazelett DJ, Wang Z, Saunders E, Leongamornlert D, Lindstrom S, Jugurnauth-Little S, Dadaev T, Tymrakiewicz M, Stram DO, Rand K, Wan P, Stram A, Sheng X, Pooler LC, Park K, Xia L, Tyrer J, Kolonel LN, Le Marchand L, Hoover RN, Machiela MJ, Yeager M, Burdette L, Chung CC, Hutchinson A, Yu K, Goh C, Ahmed M, Govindasami K, Guy M, Tammela TL, Auvinen A, Wahlfors T, Schleutker J, Visakorpi T, Leinonen KA, Xu J, Aly M, Donovan J, Travis RC, Key TJ, Siddiq A, Canzian F, Khaw KT, Takahashi A, Kubo M, Pharoah P, Pashayan N, Weischer M, Nordestgaard BG, Nielsen SF, Klarskov P, Roder MA, Iversen P, Thibodeau SN, McDonnell SK, Schaid DJ, Stanford JL, Kolb S, Holt S, Knudsen B, Coll AH, Gapstur SM, Diver WR, Stevens VL, Maier C, Luedeke M, Herkommer K, Rinckleb AE, Strom SS, Pettaway C, Yeboah ED, Tettey Y, Biritwum RB, Adjei AA, Tay E, Truelove A, Niwa S, Chokkalingam AP, Cannon-Albright L, Cybulski C, Wokolorczyk D, Kluzniak W, Park J, Sellers T, Lin HY, Isaacs WB, Partin AW, Brenner H, Dieffenbach AK, Stegmaier C, Chen C, Giovannucci EL, Ma J, Stampfer M, Penney KL, Mucci L, John EM, Ingles SA, Kittles RA, Murphy AB, Pandha H, Michael A, Kierzek AM, Blot W, Signorello LB, Zheng W, Albanes D, Virtamo J, Weinstein S, Nemesure B, Carpten J, Leske C, Wu SY, Hennis A, Kibel AS, Rybicki BA, Neslund-Dudas C, Hsing AW, Chu L, Goodman PJ, Klein EA, Zheng SL, Batra J, Clements J, Spurdle A, Teixeira MR, Paulo P, Maia S, Slavov C, Kaneva R, Mitev V, Witte JS, Casey G, Gillanders EM, Seminara D, Riboli E, Hamdy FC, Coetzee GA, Li Q, Freedman ML, Hunter DJ, Muir K, Gronberg H, Neal DE, Southey M, Giles GG, Severi G; Breast and Prostate Cancer Cohort Consortium (BPC3); PRACTICAL (Prostate Cancer Association Group to Investigate Cancer-Associated Alterations in the Genome) Consortium; COGS (Collaborative Oncological Gene-environment Study) Consortium; GAME-ON/ELLIPSE Consortium; Cook MB, Nakagawa H, Wiklund F, Kraft P, Chanock SJ, Henderson BE, Easton DF, Eeles RA, Haiman CA. A meta-analysis of 87,040 individuals identifies 23 new susceptibility loci for prostate cancer. Nat Genet. 2014 Oct;46(10):1103-9. doi: 10.1038/ng.3094. Epub 2014 Sep 14.</citation>
    <PMID>25217961</PMID>
  </reference>
  <reference>
    <citation>Haraldsdottir S, Hampel H, Wei L, Wu C, Frankel W, Bekaii-Saab T, de la Chapelle A, Goldberg RM. Prostate cancer incidence in males with Lynch syndrome. Genet Med. 2014 Jul;16(7):553-7. doi: 10.1038/gim.2013.193. Epub 2014 Jan 16.</citation>
    <PMID>24434690</PMID>
  </reference>
  <reference>
    <citation>Giri VN, Knudsen KE, Kelly WK, Abida W, Andriole GL, Bangma CH, Bekelman JE, Benson MC, Blanco A, Burnett A, Catalona WJ, Cooney KA, Cooperberg M, Crawford DE, Den RB, Dicker AP, Eggener S, Fleshner N, Freedman ML, Hamdy FC, Hoffman-Censits J, Hurwitz MD, Hyatt C, Isaacs WB, Kane CJ, Kantoff P, Karnes RJ, Karsh LI, Klein EA, Lin DW, Loughlin KR, Lu-Yao G, Malkowicz SB, Mann MJ, Mark JR, McCue PA, Miner MM, Morgan T, Moul JW, Myers RE, Nielsen SM, Obeid E, Pavlovich CP, Peiper SC, Penson DF, Petrylak D, Pettaway CA, Pilarski R, Pinto PA, Poage W, Raj GV, Rebbeck TR, Robson ME, Rosenberg MT, Sandler H, Sartor O, Schaeffer E, Schwartz GF, Shahin MS, Shore ND, Shuch B, Soule HR, Tomlins SA, Trabulsi EJ, Uzzo R, Vander Griend DJ, Walsh PC, Weil CJ, Wender R, Gomella LG. Role of Genetic Testing for Inherited Prostate Cancer Risk: Philadelphia Prostate Cancer Consensus Conference 2017. J Clin Oncol. 2018 Feb 1;36(4):414-424. doi: 10.1200/JCO.2017.74.1173. Epub 2017 Dec 13.</citation>
    <PMID>29236593</PMID>
  </reference>
  <verification_date>January 23, 2023</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>August 30, 2023</last_update_submitted>
  <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>BRCA 1</keyword>
  <keyword>BRCA 2</keyword>
  <keyword>MMR genes</keyword>
  <keyword>Lynch Syndrome</keyword>
  <keyword>Natural History</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>. All IPD recorded in the medical record will be shared with intramural investigators upon request. @@@@@@ In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Clinical data available during the study and indefinitely.@@@@@@ Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active.</ipd_time_frame>
    <ipd_access_criteria>Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.@@@@@@ Genomic data are made available via dbGaP through requests to the data custodians.</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03805919
org study id: 190040
secondary id: 19-C-0040
nct id: NCT03805919
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Background:

      Research studies have shown that genetic changes and family history may increase a man s risk
      for prostate cancer. Researchers want to follow the prostate health of men who have specific
      genetic changes associated with prostate cancer to help them learn more about which men are
      at higher risk for prostate cancer.

      Objectives:

      To study men with specific genetic changes and determine who is at higher risk for getting
      prostate cancer. To study if certain genetic changes and family history can be used to help
      prevent or treat prostate cancer.

      Eligibility:

      Persons assigned male at birth ages 30-75 who have one or more specific genetic changes but
      without prostate cancer.

      Design:

        -  This study does not perform genetic testing. All participants must have documented
           genetic changes and able to provide a copy of the report.

        -  Before enrollment, participants will provide a copy of documented genetic changes and go
           through a telephone interview to determine eligibility for the study.

        -  On enrollment, participants will have medical and family history review, medication
           review, physical exam, blood collection for clinical and research testing, and MRI
           (magnetic resonance imaging) of the prostate.

        -  Every year, participants will repeat the physical exam, medical history, family history,
           medication review, routine blood tests, including PSA and testosterone.

        -  Every 2 years, participants will repeat all the above plus prostate MRI and blood tests
           for research.

        -  If, at any time, the physical exam, blood tests or MRI are abnormal, participants may be
           asked to do a biopsy.

        -  If the biopsy results in prostate cancer, participants will be given counseling on next
           steps, general treatment recommendations, and then followed with a phone call each year.

        -  Participants may ask to speak with a genetic counselor.
Background:

      Prostate cancer is the most common malignancy and the second leading cause of cancer-related
      deaths in American men.

      Prostate cancer has substantial inherited predisposition and certain genetic variants that
      are associated with an increased risk of prostate cancer.

      An evolving approach to prostate cancer screening is to target populations at risk of
      developing prostate cancer based on their genetic predisposition.

      Objective:

      To follow the natural history of men with known germline variants or likely pathogenic
      variants in genes that put them at risk for developing prostate cancer.

      Eligibility:

      Persons assigned male at birth who are between ages 30-75 years old.

      Documented germline pathogenic or likely pathogenic variants in prostate cancer-related risk
      gene: BRCA 1 and 2, DNA Mismatch Repair (MMR) genes associated with Lynch syndrome (MLH1,
      MSH2, MSH6, PMS2, and EPCAM), HOXB13, ATM, NBN, TP53, CHEK2, PALB2, RAD51C, RAD51D, BRIP1, or
      FANC (FANCA, FANCB, FANCC, FANCD2, FANCE, FANCF, FANCG, FANCI, FANCL, and FANCM).

      Must be able and willing to provide informed consent.

      Design:

      Up to 500 subjects will be enrolled.

      Participants will undergo sampling of blood for prostate-specific antigen. Based on these
      results and age, participants will be considered for biopsy and/or continued monitoring if
      feasible upon clinical discretion.

      Participants will undergo a baseline MRI evaluation with follow-up scans every 2 years as
      clinically indicated.

      Following initial evaluation, participants will be followed as clinically indicated, usually
      at 12 month intervals, to determine their PSA level, prostate cancer treatment (if relevant)
      and/or disease/survival status until death.
observational model: Cohort
time perspective: Prospective
measure: Natural history of high genetic risk for prostate cancer
time frame: one year
description: To follow the natural history of men with known germline variants or likely pathogenic variants in genes that put them at high risk for developing prostate cancer
measure: mpMRI feasibility
time frame: baseline and every two years until death or when criteria for removal from study is met
description: test the feasibility and accuracy of multi parametric magnetic resonance imaging (mpMRI) for the localization and detection of local prostate cancer
measure: role of mpMRI
time frame: baseline and every two years until death or when criteria for removal from study is met
description: role of mpMRI in monitoring participants on active surveillance and as a follow up tool for monitoring local disease progression
arm group label: Cohort 1
description: Participants with germline pathogenic or likely pathogenic variants in prostate cancer-related risk genes
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 30 Years
maximum age: 75 Years
healthy volunteers: No
last name: Fatima H Karzai, M.D.
role: Principal Investigator
affiliation: National Cancer Institute (NCI)
last name: Anna C Couvillon, C.R.N.P.
phone: (240) 858-3148
email: couvilla@mail.nih.gov
last name: Fatima H Karzai, M.D.
phone: (301) 480-7174
email: fatima.karzai@nih.gov
facility: 
status: Recruiting
contact: 
country: United States
url: https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2019-C-0040.html
description: NIH Clinical Center Detailed Web Page
citation: Al Olama AA, Kote-Jarai Z, Berndt SI, Conti DV, Schumacher F, Han Y, Benlloch S, Hazelett DJ, Wang Z, Saunders E, Leongamornlert D, Lindstrom S, Jugurnauth-Little S, Dadaev T, Tymrakiewicz M, Stram DO, Rand K, Wan P, Stram A, Sheng X, Pooler LC, Park K, Xia L, Tyrer J, Kolonel LN, Le Marchand L, Hoover RN, Machiela MJ, Yeager M, Burdette L, Chung CC, Hutchinson A, Yu K, Goh C, Ahmed M, Govindasami K, Guy M, Tammela TL, Auvinen A, Wahlfors T, Schleutker J, Visakorpi T, Leinonen KA, Xu J, Aly M, Donovan J, Travis RC, Key TJ, Siddiq A, Canzian F, Khaw KT, Takahashi A, Kubo M, Pharoah P, Pashayan N, Weischer M, Nordestgaard BG, Nielsen SF, Klarskov P, Roder MA, Iversen P, Thibodeau SN, McDonnell SK, Schaid DJ, Stanford JL, Kolb S, Holt S, Knudsen B, Coll AH, Gapstur SM, Diver WR, Stevens VL, Maier C, Luedeke M, Herkommer K, Rinckleb AE, Strom SS, Pettaway C, Yeboah ED, Tettey Y, Biritwum RB, Adjei AA, Tay E, Truelove A, Niwa S, Chokkalingam AP, Cannon-Albright L, Cybulski C, Wokolorczyk D, Kluzniak W, Park J, Sellers T, Lin HY, Isaacs WB, Partin AW, Brenner H, Dieffenbach AK, Stegmaier C, Chen C, Giovannucci EL, Ma J, Stampfer M, Penney KL, Mucci L, John EM, Ingles SA, Kittles RA, Murphy AB, Pandha H, Michael A, Kierzek AM, Blot W, Signorello LB, Zheng W, Albanes D, Virtamo J, Weinstein S, Nemesure B, Carpten J, Leske C, Wu SY, Hennis A, Kibel AS, Rybicki BA, Neslund-Dudas C, Hsing AW, Chu L, Goodman PJ, Klein EA, Zheng SL, Batra J, Clements J, Spurdle A, Teixeira MR, Paulo P, Maia S, Slavov C, Kaneva R, Mitev V, Witte JS, Casey G, Gillanders EM, Seminara D, Riboli E, Hamdy FC, Coetzee GA, Li Q, Freedman ML, Hunter DJ, Muir K, Gronberg H, Neal DE, Southey M, Giles GG, Severi G; Breast and Prostate Cancer Cohort Consortium (BPC3); PRACTICAL (Prostate Cancer Association Group to Investigate Cancer-Associated Alterations in the Genome) Consortium; COGS (Collaborative Oncological Gene-environment Study) Consortium; GAME-ON/ELLIPSE Consortium; Cook MB, Nakagawa H, Wiklund F, Kraft P, Chanock SJ, Henderson BE, Easton DF, Eeles RA, Haiman CA. A meta-analysis of 87,040 individuals identifies 23 new susceptibility loci for prostate cancer. Nat Genet. 2014 Oct;46(10):1103-9. doi: 10.1038/ng.3094. Epub 2014 Sep 14.
PMID: 25217961
citation: Haraldsdottir S, Hampel H, Wei L, Wu C, Frankel W, Bekaii-Saab T, de la Chapelle A, Goldberg RM. Prostate cancer incidence in males with Lynch syndrome. Genet Med. 2014 Jul;16(7):553-7. doi: 10.1038/gim.2013.193. Epub 2014 Jan 16.
PMID: 24434690
citation: Giri VN, Knudsen KE, Kelly WK, Abida W, Andriole GL, Bangma CH, Bekelman JE, Benson MC, Blanco A, Burnett A, Catalona WJ, Cooney KA, Cooperberg M, Crawford DE, Den RB, Dicker AP, Eggener S, Fleshner N, Freedman ML, Hamdy FC, Hoffman-Censits J, Hurwitz MD, Hyatt C, Isaacs WB, Kane CJ, Kantoff P, Karnes RJ, Karsh LI, Klein EA, Lin DW, Loughlin KR, Lu-Yao G, Malkowicz SB, Mann MJ, Mark JR, McCue PA, Miner MM, Morgan T, Moul JW, Myers RE, Nielsen SM, Obeid E, Pavlovich CP, Peiper SC, Penson DF, Petrylak D, Pettaway CA, Pilarski R, Pinto PA, Poage W, Raj GV, Rebbeck TR, Robson ME, Rosenberg MT, Sandler H, Sartor O, Schaeffer E, Schwartz GF, Shahin MS, Shore ND, Shuch B, Soule HR, Tomlins SA, Trabulsi EJ, Uzzo R, Vander Griend DJ, Walsh PC, Weil CJ, Wender R, Gomella LG. Role of Genetic Testing for Inherited Prostate Cancer Risk: Philadelphia Prostate Cancer Consensus Conference 2017. J Clin Oncol. 2018 Feb 1;36(4):414-424. doi: 10.1200/JCO.2017.74.1173. Epub 2017 Dec 13.
PMID: 29236593
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
sharing ipd: Yes
ipd description: . All IPD recorded in the medical record will be shared with intramural investigators upon request. @@@@@@ In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: Clinical data available during the study and indefinitely.@@@@@@ Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active.
ipd access criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.@@@@@@ Genomic data are made available via dbGaP through requests to the data custodians.