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Prostate CancerNCT01221168

Epidemiologic and Genetic Study on Familial Prostate Cancer

An observational study of Prostate Cancer, run by Centre de Recherche sur les Pathologies Prostatiques at 5 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The aims of the study are: to identify genetic and molecular factors (rare mutations, polymorphisms) involved in the natural history of prostate cancers and their response to treatment, to evaluate and deduce their medical applications for screening and therapeutic management of these tumors. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Prostate Cancer
How many people
10,000 participants
Where
5 sitesFrance
Study dates
Oct 1996to Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Men with or without prostate cancer are recruited in different departments of urology or care centers in France. For hereditary prostate cancer, patients and their family members are referred by all urologists from France.

Who may be able to join

  • patient with a histological confirmed prostate cancer
  • member of a hereditary prostate cancer family
  • healthy control men without prostate cancer

Who cannot join

  • Absence of signed informed consent
  • refusal to participate in the study

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Olivier Cussenot, MD, PhD contact

00 33 1 56 01 76 46

olivier.cussenot@cerepp.org

Geraldine Cancel-Tassin, PhD contact

00 33 1 56 01 76 46

g.cancel@cerepp.org

5 sites in 1 country

France5 sites, 4 recruiting
  • Department of Urology, CHU Angers

    Angers, 49100

    Abdel-Rahmene Azzouzi, MD, PhD

    Recruiting
  • Department of Urology, Hopital de la Cavale Blanche

    Brest, 29200

    Georges Fournier, MD

    Antoine Valéri, MD, PhD

    Recruiting
  • Department of Urology, CHU Dijon

    Dijon, 21000

    Luc Cormier, MD, PhD

    Recruiting
  • Department of Urology, Hopital Pitié-Salpetriere

    Paris, 75013

    Marc-Olivier Bitker, MD

    Morgan Roupret, MD, PhD

    Recruiting
  • Department of Urology, Hopital Tenon

    Paris, 75020

    Completed

Other trials in France

About this study

Official title: ProGene: Etude Genetique et Epidemiologique du Cancer de la Prostate Familial

The aims of the study are:

  • to identify genetic and molecular factors (rare mutations, polymorphisms) involved in the natural history of prostate cancers and their response to treatment,
  • to evaluate and deduce their medical applications for screening and therapeutic management of these tumors.
Read the detailed description

The impact of genetic factors on the natural history of prostate cancer (PC) is shown schematically at two levels:

  1. first, at the constitutional level with germline alterations. Family history is found in 20% of PC patients. Different clinical entities associated with different modes of inheritance, susceptibility mutations or polymorphisms, define different evolutionary patterns. Also, studies suggested that some genetic polymorphisms alter the response to some treatments (such as recurrence after prostatectomy or radiotherapy) or adverse effects of those above (such as toxicity of radiation therapy).
  2. secondly, PC is characterized by the accumulation of genetic alterations (somatic alterations or acquired mutations). These changes contribute in varying degrees to the aggressiveness of the disease (such as early metastatic potential) and treatment failure (such as resistance to radiation or hormone resistance).

The purpose of this study is to establish a register, with a follow up of cohort type and a collection of biological samples:

  • For men with known prostate cancer.
  • For men with no prostate cancer after a screening procedure for this disease, so that their biological samples can be compared to those of men with prostate cancer.

The registry data and collected biological samples are used to identify genetic and molecular factors involved in susceptibility, genesis and evolution of prostate cancers.

Conditions
Prostate Cancer
Keywords
prostate, cancer, genetic, epidemiology, susceptibility
Medical subject headings
Prostatic Neoplasms, Neoplasms, Disease Susceptibility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01221168
Study groupRoleWhat they receive
Men with or without Prostate CancerMen with a histological confirmed prostate cancer, and their family members in case of hereditary prostate cancer. Men with no prostate cancer after a screening procedure for this disease, so that their biological samples can be compared to those of men with prostate cancer.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Performance of genetic and molecular factors in predicting the risk of prostate cancer

    Logistic regression and artificial neural networks will be used

    Measured: 20 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2010 (estimated)
  2. Study startOct 1996
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
10,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01221168
Sponsor's protocol ID
ProGene
Status last verified
May 2025
First submitted
13 Oct 2010
Last updated
23 May 2025
Results posted
No
Data monitoring committee
No

Publications

  • Cussenot O, Timms KM, Perrot E, Blanchet P, Brureau L, Solimeno C, Fromont G, Comperat E, Cancel-Tassin G. Tumour-based Mutational Profiles Predict Visceral Metastasis Outcome and Early Death in Prostate Cancer Patients. Eur Urol Oncol. 2024 Jun;7(3):597-604. doi: 10.1016/j.euo.2023.12.003. Epub 2024 Jan 5.

    PubMed 38182487
  • Wang A, Shen J, Rodriguez AA, Saunders EJ, Chen F, Janivara R, Darst BF, Sheng X, Xu Y, Chou AJ, Benlloch S, Dadaev T, Brook MN, Plym A, Sahimi A, Hoffman TJ, Takahashi A, Matsuda K, Momozawa Y, Fujita M, Laisk T, Figueredo J, Muir K, Ito S, Liu X; Biobank Japan Project; Uchio Y, Kubo M, Kamatani Y, Lophatananon A, Wan P, Andrews C, Lori A, Choudhury PP, Schleutker J, Tammela TLJ, Sipeky C, Auvinen A, Giles GG, Southey MC, MacInnis RJ, Cybulski C, Wokolorczyk D, Lubinski J, Rentsch CT, Cho K, Mcmahon BH, Neal DE, Donovan JL, Hamdy FC, Martin RM, Nordestgaard BG, Nielsen SF, Weischer M, Bojesen SE, Roder A, Stroomberg HV, Batra J, Chambers S, Horvath L, Clements JA, Tilly W, Risbridger GP, Gronberg H, Aly M, Szulkin R, Eklund M, Nordstrom T, Pashayan N, Dunning AM, Ghoussaini M, Travis RC, Key TJ, Riboli E, Park JY, Sellers TA, Lin HY, Albanes D, Weinstein S, Cook MB, Mucci LA, Giovannucci E, Lindstrom S, Kraft P, Hunter DJ, Penney KL, Turman C, Tangen CM, Goodman PJ, Thompson IM Jr, Hamilton RJ, Fleshner NE, Finelli A, Parent ME, Stanford JL, Ostrander EA, Koutros S, Beane Freeman LE, Stampfer M, Wolk A, Hakansson N, Andriole GL, Hoover RN, Machiela MJ, Sorensen KD, Borre M, Blot WJ, Zheng W, Yeboah ED, Mensah JE, Lu YJ, Zhang HW, Feng N, Mao X, Wu Y, Zhao SC, Sun Z, Thibodeau SN, McDonnell SK, Schaid DJ, West CML, Barnett G, Maier C, Schnoeller T, Luedeke M, Kibel AS, Drake BF, Cussenot O, Cancel-Tassin G, Menegaux F, Truong T, Koudou YA, John EM, Grindedal EM, Maehle L, Khaw KT, Ingles SA, Stern MC, Vega A, Gomez-Caamano A, Fachal L, Rosenstein BS, Kerns SL, Ostrer H, Teixeira MR, Paulo P, Brandao A, Watya S, Lubwama A, Bensen JT, Butler EN, Mohler JL, Taylor JA, Kogevinas M, Dierssen-Sotos T, Castano-Vinyals G, Cannon-Albright L, Teerlink CC, Huff CD, Pilie P, Yu Y, Bohlender RJ, Gu J, Strom SS, Multigner L, Blanchet P, Brureau L, Kaneva R, Slavov C, Mitev V, Leach RJ, Brenner H, Chen X, Holleczek B, Schottker B, Klein EA, Hsing AW, Kittles RA, Murphy AB, Logothetis CJ, Kim J, Neuhausen SL, Steele L, Ding YC, Isaacs WB, Nemesure B, Hennis AJM, Carpten J, Pandha H, Michael A, De Ruyck K, De Meerleer G, Ost P, Xu J, Razack A, Lim J, Teo SH, Newcomb LF, Lin DW, Fowke JH, Neslund-Dudas CM, Rybicki BA, Gamulin M, Lessel D, Kulis T, Usmani N, Abraham A, Singhal S, Parliament M, Claessens F, Joniau S, Van den Broeck T, Gago-Dominguez M, Castelao JE, Martinez ME, Larkin S, Townsend PA, Aukim-Hastie C, Bush WS, Aldrich MC, Crawford DC, Srivastava S, Cullen J, Petrovics G, Casey G, Wang Y, Tettey Y, Lachance J, Tang W, Biritwum RB, Adjei AA, Tay E, Truelove A, Niwa S, Yamoah K, Govindasami K, Chokkalingam AP, Keaton JM, Hellwege JN, Clark PE, Jalloh M, Gueye SM, Niang L, Ogunbiyi O, Shittu O, Amodu O, Adebiyi AO, Aisuodionoe-Shadrach OI, Ajibola HO, Jamda MA, Oluwole OP, Nwegbu M, Adusei B, Mante S, Darkwa-Abrahams A, Diop H, Gundell SM, Roobol MJ, Jenster G, van Schaik RHN, Hu JJ, Sanderson M, Kachuri L, Varma R, McKean-Cowdin R, Torres M, Preuss MH, Loos RJF, Zawistowski M, Zollner S, Lu Z, Van Den Eeden SK, Easton DF, Ambs S, Edwards TL, Magi R, Rebbeck TR, Fritsche L, Chanock SJ, Berndt SI, Wiklund F, Nakagawa H, Witte JS, Gaziano JM, Justice AC, Mancuso N, Terao C, Eeles RA, Kote-Jarai Z, Madduri RK, Conti DV, Haiman CA. Characterizing prostate cancer risk through multi-ancestry genome-wide discovery of 187 novel risk variants. Nat Genet. 2023 Dec;55(12):2065-2074. doi: 10.1038/s41588-023-01534-4. Epub 2023 Nov 9.

    PubMed 37945903
  • Cussenot O, Cancel-Tassin G, Rao SR, Woodcock DJ, Lamb AD, Mills IG, Hamdy FC. Aligning germline and somatic mutations in prostate cancer. Are genetics changing practice? BJU Int. 2023 Nov;132(5):472-484. doi: 10.1111/bju.16120. Epub 2023 Jul 27.

    PubMed 37410655
  • Darst BF, Shen J, Madduri RK, Rodriguez AA, Xiao Y, Sheng X, Saunders EJ, Dadaev T, Brook MN, Hoffmann TJ, Muir K, Wan P, Le Marchand L, Wilkens L, Wang Y, Schleutker J, MacInnis RJ, Cybulski C, Neal DE, Nordestgaard BG, Nielsen SF, Batra J, Clements JA, Cancer BioResource AP, Gronberg H, Pashayan N, Travis RC, Park JY, Albanes D, Weinstein S, Mucci LA, Hunter DJ, Penney KL, Tangen CM, Hamilton RJ, Parent ME, Stanford JL, Koutros S, Wolk A, Sorensen KD, Blot WJ, Yeboah ED, Mensah JE, Lu YJ, Schaid DJ, Thibodeau SN, West CM, Maier C, Kibel AS, Cancel-Tassin G, Menegaux F, John EM, Grindedal EM, Khaw KT, Ingles SA, Vega A, Rosenstein BS, Teixeira MR; NC-LA PCaP Investigators; Kogevinas M, Cannon-Albright L, Huff C, Multigner L, Kaneva R, Leach RJ, Brenner H, Hsing AW, Kittles RA, Murphy AB, Logothetis CJ, Neuhausen SL, Isaacs WB, Nemesure B, Hennis AJ, Carpten J, Pandha H, De Ruyck K, Xu J, Razack A, Teo SH; Canary PASS Investigators; Newcomb LF, Fowke JH, Neslund-Dudas C, Rybicki BA, Gamulin M, Usmani N, Claessens F, Gago-Dominguez M, Castelao JE, Townsend PA, Crawford DC, Petrovics G, Casey G, Roobol MJ, Hu JF, Berndt SI, Van Den Eeden SK, Easton DF, Chanock SJ, Cook MB, Wiklund F, Witte JS, Eeles RA, Kote-Jarai Z, Watya S, Gaziano JM, Justice AC, Conti DV, Haiman CA. Evaluating approaches for constructing polygenic risk scores for prostate cancer in men of African and European ancestry. Am J Hum Genet. 2023 Jul 6;110(7):1200-1206. doi: 10.1016/j.ajhg.2023.05.010. Epub 2023 Jun 12.

    PubMed 37311464
  • Cussenot O, Renard-Penna R, Montagne S, Ondet V, Pilon A, Guechot J, Comperat E, Hamdy F, Lamb A, Cancel-Tassin G. Clinical performance of magnetic resonance imaging and biomarkers for prostate cancer diagnosis in men at high genetic risk. BJU Int. 2023 Jun;131(6):745-754. doi: 10.1111/bju.15968. Epub 2023 Feb 6.

    PubMed 36648168
  • Chen F, Madduri RK, Rodriguez AA, Darst BF, Chou A, Sheng X, Wang A, Shen J, Saunders EJ, Rhie SK, Bensen JT, Ingles SA, Kittles RA, Strom SS, Rybicki BA, Nemesure B, Isaacs WB, Stanford JL, Zheng W, Sanderson M, John EM, Park JY, Xu J, Wang Y, Berndt SI, Huff CD, Yeboah ED, Tettey Y, Lachance J, Tang W, Rentsch CT, Cho K, Mcmahon BH, Biritwum RB, Adjei AA, Tay E, Truelove A, Niwa S, Sellers TA, Yamoah K, Murphy AB, Crawford DC, Patel AV, Bush WS, Aldrich MC, Cussenot O, Petrovics G, Cullen J, Neslund-Dudas CM, Stern MC, Kote-Jarai Z, Govindasami K, Cook MB, Chokkalingam AP, Hsing AW, Goodman PJ, Hoffmann TJ, Drake BF, Hu JJ, Keaton JM, Hellwege JN, Clark PE, Jalloh M, Gueye SM, Niang L, Ogunbiyi O, Idowu MO, Popoola O, Adebiyi AO, Aisuodionoe-Shadrach OI, Ajibola HO, Jamda MA, Oluwole OP, Nwegbu M, Adusei B, Mante S, Darkwa-Abrahams A, Mensah JE, Diop H, Van Den Eeden SK, Blanchet P, Fowke JH, Casey G, Hennis AJ, Lubwama A, Thompson IM Jr, Leach R, Easton DF, Preuss MH, Loos RJ, Gundell SM, Wan P, Mohler JL, Fontham ET, Smith GJ, Taylor JA, Srivastava S, Eeles RA, Carpten JD, Kibel AS, Multigner L, Parent ME, Menegaux F, Cancel-Tassin G, Klein EA, Andrews C, Rebbeck TR, Brureau L, Ambs S, Edwards TL, Watya S, Chanock SJ, Witte JS, Blot WJ, Michael Gaziano J, Justice AC, Conti DV, Haiman CA. Evidence of Novel Susceptibility Variants for Prostate Cancer and a Multiancestry Polygenic Risk Score Associated with Aggressive Disease in Men of African Ancestry. Eur Urol. 2023 Jul;84(1):13-21. doi: 10.1016/j.eururo.2023.01.022. Epub 2023 Mar 3.

    PubMed 36872133
  • Fang S, Yarmolinsky J, Gill D, Bull CJ, Perks CM; PRACTICAL Consortium; Davey Smith G, Gaunt TR, Richardson TG. Association between genetically proxied PCSK9 inhibition and prostate cancer risk: A Mendelian randomisation study. PLoS Med. 2023 Jan 3;20(1):e1003988. doi: 10.1371/journal.pmed.1003988. eCollection 2023 Jan.

    PubMed 36595504
  • Abdi B, Basset N, Perrot E, Benderra MA, Khalil A, Oudard S, Blanchet P, Brureau L, Coulet F, Cussenot O, Cancel-Tassin G. DNA damage repair gene germline profiling for metastatic prostate cancer patients of different ancestries. Prostate. 2022 Sep;82(12):1196-1201. doi: 10.1002/pros.24374. Epub 2022 Jun 2.

    PubMed 35652560
  • Burns D, Anokian E, Saunders EJ, Bristow RG, Fraser M, Reimand J, Schlomm T, Sauter G, Brors B, Korbel J, Weischenfeldt J, Waszak SM, Corcoran NM, Jung CH, Pope BJ, Hovens CM, Cancel-Tassin G, Cussenot O, Loda M, Sander C, Hayes VM, Dalsgaard Sorensen K, Lu YJ, Hamdy FC, Foster CS, Gnanapragasam V, Butler A, Lynch AG, Massie CE; CR-UK/Prostate Cancer UK, ICGC, The PPCG; Woodcock DJ, Cooper CS, Wedge DC, Brewer DS, Kote-Jarai Z, Eeles RA. Rare Germline Variants Are Associated with Rapid Biochemical Recurrence After Radical Prostate Cancer Treatment: A Pan Prostate Cancer Group Study. Eur Urol. 2022 Aug;82(2):201-211. doi: 10.1016/j.eururo.2022.05.007. Epub 2022 May 31.

    PubMed 35659150
  • Kuhl V, Clegg W, Meek S, Lenz L, Flake DD 2nd, Ronan T, Kornilov M, Horsch D, Scheer M, Farber D, Zalaznick H, Cussenot O, Comperat E, Cancel-Tassin G, Wild PJ, Chun FK, Mandel P, Moinfar F, Cohen T, Delee S, Kronenwett R, Doedt J. Development and validation of a cell cycle progression signature for decentralized testing of men with prostate cancer. Biomark Med. 2022 Apr;16(6):449-459. doi: 10.2217/bmm-2021-0479. Epub 2022 Mar 24.

    PubMed 35321552
  • Huynh-Le MP, Karunamuni R, Fan CC, Asona L, Thompson WK, Martinez ME, Eeles RA, Kote-Jarai Z, Muir KR, Lophatananon A, Schleutker J, Pashayan N, Batra J, Gronberg H, Neal DE, Nordestgaard BG, Tangen CM, MacInnis RJ, Wolk A, Albanes D, Haiman CA, Travis RC, Blot WJ, Stanford JL, Mucci LA, West CML, Nielsen SF, Kibel AS, Cussenot O, Berndt SI, Koutros S, Sorensen KD, Cybulski C, Grindedal EM, Menegaux F, Park JY, Ingles SA, Maier C, Hamilton RJ, Rosenstein BS, Lu YJ, Watya S, Vega A, Kogevinas M, Wiklund F, Penney KL, Huff CD, Teixeira MR, Multigner L, Leach RJ, Brenner H, John EM, Kaneva R, Logothetis CJ, Neuhausen SL, De Ruyck K, Ost P, Razack A, Newcomb LF, Fowke JH, Gamulin M, Abraham A, Claessens F, Castelao JE, Townsend PA, Crawford DC, Petrovics G, van Schaik RHN, Parent ME, Hu JJ, Zheng W; UKGPCS collaborators; APCB (Australian Prostate Cancer BioResource); NC-LA PCaP Investigators; IMPACT Study Steering Committee and Collaborators; Canary PASS Investigators; Profile Study Steering Committee; PRACTICAL Consortium; Mills IG, Andreassen OA, Dale AM, Seibert TM. Prostate cancer risk stratification improvement across multiple ancestries with new polygenic hazard score. Prostate Cancer Prostatic Dis. 2022 Apr;25(4):755-761. doi: 10.1038/s41391-022-00497-7. Epub 2022 Feb 12.

    PubMed 35152271
  • Karunamuni RA, Huynh-Le MP, Fan CC, Thompson W, Lui A, Martinez ME, Rose BS, Mahal B, Eeles RA, Kote-Jarai Z, Muir K, Lophatananon A; UKGPCS Collaborators; Tangen CM, Goodman PJ, Thompson IM Jr, Blot WJ, Zheng W, Kibel AS, Drake BF, Cussenot O, Cancel-Tassin G, Menegaux F, Truong T, Park JY, Lin HY, Taylor JA, Bensen JT, Mohler JL, Fontham ETH, Multigner L, Blanchet P, Brureau L, Romana M, Leach RJ, John EM, Fowke JH, Bush WS, Aldrich MC, Crawford DC, Cullen J, Petrovics G, Parent ME, Hu JJ, Sanderson M; PRACTICAL Consortium; Mills IG, Andreassen OA, Dale AM, Seibert TM. Performance of African-ancestry-specific polygenic hazard score varies according to local ancestry in 8q24. Prostate Cancer Prostatic Dis. 2022 Feb;25(2):229-237. doi: 10.1038/s41391-021-00403-7. Epub 2021 Jun 14.

    PubMed 34127801
  • Darst BF, Hughley R, Pfennig A, Hazra U, Fan C, Wan P, Sheng X, Xia L, Andrews C, Chen F, Berndt SI, Kote-Jarai Z, Govindasami K, Bensen JT, Ingles SA, Rybicki BA, Nemesure B, John EM, Fowke JH, Huff CD, Strom SS, Isaacs WB, Park JY, Zheng W, Ostrander EA, Walsh PC, Carpten J, Sellers TA, Yamoah K, Murphy AB, Sanderson M, Crawford DC, Gapstur SM, Bush WS, Aldrich MC, Cussenot O, Petrovics G, Cullen J, Neslund-Dudas C, Kittles RA, Xu J, Stern MC, Chokkalingam AP, Multigner L, Parent ME, Menegaux F, Cancel-Tassin G, Kibel AS, Klein EA, Goodman PJ, Stanford JL, Drake BF, Hu JJ, Clark PE, Blanchet P, Casey G, Hennis AJM, Lubwama A, Thompson IM Jr, Leach RJ, Gundell SM, Pooler L, Mohler JL, Fontham ETH, Smith GJ, Taylor JA, Brureau L, Blot WJ, Biritwum R, Tay E, Truelove A, Niwa S, Tettey Y, Varma R, McKean-Cowdin R, Torres M, Jalloh M, Magueye Gueye S, Niang L, Ogunbiyi O, Oladimeji Idowu M, Popoola O, Adebiyi AO, Aisuodionoe-Shadrach OI, Nwegbu M, Adusei B, Mante S, Darkwa-Abrahams A, Yeboah ED, Mensah JE, Anthony Adjei A, Diop H, Cook MB, Chanock SJ, Watya S, Eeles RA, Chiang CWK, Lachance J, Rebbeck TR, Conti DV, Haiman CA. A Rare Germline HOXB13 Variant Contributes to Risk of Prostate Cancer in Men of African Ancestry. Eur Urol. 2022 May;81(5):458-462. doi: 10.1016/j.eururo.2021.12.023. Epub 2022 Jan 12.

    PubMed 35031163
  • Karlsson Q, Brook MN, Dadaev T, Wakerell S, Saunders EJ, Muir K, Neal DE, Giles GG, MacInnis RJ, Thibodeau SN, McDonnell SK, Cannon-Albright L, Teixeira MR, Paulo P, Cardoso M, Huff C, Li D, Yao Y, Scheet P, Permuth JB, Stanford JL, Dai JY, Ostrander EA, Cussenot O, Cancel-Tassin G, Hoegel J, Herkommer K, Schleutker J, Tammela TLJ, Rathinakannan V, Sipeky C, Wiklund F, Gronberg H, Aly M, Isaacs WB, Dickinson JL, FitzGerald LM, Chua MLK, Nguyen-Dumont T; PRACTICAL Consortium; Schaid DJ, Southey MC, Eeles RA, Kote-Jarai Z. Rare Germline Variants in ATM Predispose to Prostate Cancer: A PRACTICAL Consortium Study. Eur Urol Oncol. 2021 Aug;4(4):570-579. doi: 10.1016/j.euo.2020.12.001. Epub 2021 Jan 9.

    PubMed 33436325
  • Wang V, Geybels MS, Jordahl KM, Gerke T, Hamid A, Penney KL, Markt SC, Freedman M, Pomerantz M, Lee GM, Rana H, Bornigen D, Rebbeck TR, Huttenhower C, Eeles RA, Stanford JL, Consortium P, Berndt SI, Claessens F, Sorensen KD, Park JY, Vega A, Usmani N, Mucci L, Sweeney CJ. A polymorphism in the promoter of FRAS1 is a candidate SNP associated with metastatic prostate cancer. Prostate. 2021 Jul;81(10):683-693. doi: 10.1002/pros.24148. Epub 2021 May 6.

    PubMed 33956343

Questions about this trial

What is this clinical trial studying?

An observational study of Prostate Cancer, run by Centre de Recherche sur les Pathologies Prostatiques at 5 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in France. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Olivier Cussenot, MD, PhD (00 33 1 56 01 76 46, olivier.cussenot@cerepp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Performance of genetic and molecular factors in predicting the risk of prostate cancer (time frame: 20 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01221168, which also lists 85 linked publications.

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 23 May 2025.

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