Epidemiologic and Genetic Study on Familial Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01221168
• Other study ID #: ProGene
• Status: Recruiting
• Phase: N/A
• First received: October 13, 2010
• Last updated: February 11, 2015
• Start date: October 1996
• Est. completion date: December 2016

Study information

• Verified date: February 2015
• Source: Centre de Recherche sur les Pathologies Prostatiques
• Contact: Olivier Cussenot, MD, PhD
• Phone: 00 33 1 56 01 64 95
• Email: olivier.cussenot[@]tnn.aphp.fr
• Is FDA regulated: No
• Health authority: France: Direction Générale de la SantéFrance: French Data Protection Authority
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6000
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patient with a histological confirmed prostate cancer

• member of a hereditary prostate cancer family

• healthy control men without prostate cancer

Exclusion Criteria:

• Absence of signed informed consent

• refusal to participate in the study

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
France	Department of Urology, CHU Angers	Angers
France	Department of Urology, Hopital de la Cavale Blanche	Brest
France	Department of Urology, CHU Dijon	Dijon
France	Department of Urology, Hopital Pitié-Salpetriere	Paris
France	Department of Urology, Hopital Tenon	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Centre de Recherche sur les Pathologies Prostatiques

Country where clinical trial is conducted

France, 

References & Publications (30)

Ahn J, Berndt SI, Wacholder S, Kraft P, Kibel AS, Yeager M, Albanes D, Giovannucci E, Stampfer MJ, Virtamo J, Thun MJ, Feigelson HS, Cancel-Tassin G, Cussenot O, Thomas G, Hunter DJ, Fraumeni JF Jr, Hoover RN, Chanock SJ, Hayes RB. Variation in KLK genes, — View Citation

Azzouzi AR, Cochand-Priollet B, Mangin P, Fournier G, Berthon P, Latil A, Cussenot O. Impact of constitutional genetic variation in androgen/oestrogen-regulating genes on age-related changes in human prostate. Eur J Endocrinol. 2002 Oct;147(4):479-84. — View Citation

Azzouzi AR, Stoppa-Lyonnet D, Roupret M, Larre S, Mangin P, Cussenot O. BRCA2 mutation screening is clinically relevant in breast and early prostate cancer families. Int J Urol. 2007 May;14(5):445-6. — View Citation

Berthon P, Valeri A, Cohen-Akenine A, Drelon E, Paiss T, Wöhr G, Latil A, Millasseau P, Mellah I, Cohen N, Blanché H, Bellané-Chantelot C, Demenais F, Teillac P, Le Duc A, de Petriconi R, Hautmann R, Chumakov I, Bachner L, Maitland NJ, Lidereau R, Vogel W — View Citation

Cancel-Tassin G, Latil A, Rousseau F, Mangin P, Bottius E, Escary JL, Berthon P, Cussenot O. Association study of polymorphisms in the human estrogen receptor alpha gene and prostate cancer risk. Eur Urol. 2003 Oct;44(4):487-90. — View Citation

Cancel-Tassin G, Latil A, Valéri A, Mangin P, Fournier G, Berthon P, Cussenot O. PCAP is the major known prostate cancer predisposing locus in families from south and west Europe. Eur J Hum Genet. 2001 Feb;9(2):135-42. — View Citation

Cormier L, Guillemin F, Valéri A, Fournier G, Cussenot O, Mangin P, Litwin MS. Impact of prostate cancer screening on health-related quality of life in at-risk families. Urology. 2002 Jun;59(6):901-6. — View Citation

Correa-Cerro L, Berthon P, Häussler J, Bochum S, Drelon E, Mangin P, Fournier G, Paiss T, Cussenot O, Vogel W. Vitamin D receptor polymorphisms as markers in prostate cancer. Hum Genet. 1999 Sep;105(3):281-7. — View Citation

Correa-Cerro L, Wöhr G, Häussler J, Berthon P, Drelon E, Mangin P, Fournier G, Cussenot O, Kraus P, Just W, Paiss T, Cantú JM, Vogel W. (CAG)nCAA and GGN repeats in the human androgen receptor gene are not associated with prostate cancer in a French-Germa — View Citation

Cussenot O, Azzouzi AR, Bantsimba-Malanda G, Gaffory C, Mangin P, Cormier L, Fournier G, Valeri A, Jouffe L, Roupret M, Fromont G, Sibony M, Comperat E, Cancel-Tassin G. Effect of genetic variability within 8q24 on aggressiveness patterns at diagnosis and — View Citation

Cussenot O, Azzouzi AR, Nicolaiew N, Fromont G, Mangin P, Cormier L, Fournier G, Valeri A, Larre S, Thibault F, Giordanella JP, Pouchard M, Zheng Y, Hamdy FC, Cox A, Cancel-Tassin G. Combination of polymorphisms from genes related to estrogen metabolism a — View Citation

Cussenot O, Azzouzi AR, Nicolaiew N, Mangin P, Cormier L, Fournier G, Valeri A, Cancel-Tassin G. Low-activity V89L variant in SRD5A2 is associated with aggressive prostate cancer risk: an explanation for the adverse effects observed in chemoprevention tri — View Citation

Fromont G, Chene L, Vidaud M, Vallancien G, Mangin P, Fournier G, Validire P, Latil A, Cussenot O. Differential expression of 37 selected genes in hormone-refractory prostate cancer using quantitative taqman real-time RT-PCR. Int J Cancer. 2005 Mar 20;114 — View Citation

Fromont G, Joulin V, Chantrel-Groussard K, Vallancien G, Guillonneau B, Validire P, Latil A, Cussenot O. Allelic losses in localized prostate cancer: association with prognostic factors. J Urol. 2003 Oct;170(4 Pt 1):1394-7. — View Citation

Fromont G, Yacoub M, Valeri A, Mangin P, Vallancien G, Cancel-Tassin G, Cussenot O. Differential expression of genes related to androgen and estrogen metabolism in hereditary versus sporadic prostate cancer. Cancer Epidemiol Biomarkers Prev. 2008 Jun;17(6 — View Citation

Latil A, Chêne L, Mangin P, Fournier G, Berthon P, Cussenot O. Extensive analysis of the 13q14 region in human prostate tumors: DNA analysis and quantitative expression of genes lying in the interval of deletion. Prostate. 2003 Sep 15;57(1):39-50. — View Citation

Latil AG, Azzouzi R, Cancel GS, Guillaume EC, Cochan-Priollet B, Berthon PL, Cussenot O. Prostate carcinoma risk and allelic variants of genes involved in androgen biosynthesis and metabolism pathways. Cancer. 2001 Sep 1;92(5):1130-7. — View Citation

Lou H, Yeager M, Li H, Bosquet JG, Hayes RB, Orr N, Yu K, Hutchinson A, Jacobs KB, Kraft P, Wacholder S, Chatterjee N, Feigelson HS, Thun MJ, Diver WR, Albanes D, Virtamo J, Weinstein S, Ma J, Gaziano JM, Stampfer M, Schumacher FR, Giovannucci E, Cancel-T — View Citation

Nicolaiew N, Cancel-Tassin G, Azzouzi AR, Grand BL, Mangin P, Cormier L, Fournier G, Giordanella JP, Pouchard M, Escary JL, Valeri A, Cussenot O. Association between estrogen and androgen receptor genes and prostate cancer risk. Eur J Endocrinol. 2009 Jan — View Citation

Prokunina-Olsson L, Fu YP, Tang W, Jacobs KB, Hayes RB, Kraft P, Berndt SI, Wacholder S, Yu K, Hutchinson A, Spencer Feigelson H, Thun MJ, Diver WR, Albanes D, Virtamo J, Weinstein S, Schumacher FR, Cancel-Tassin G, Cussenot O, Valeri A, Andriole GL, Craw — View Citation

Roumier X, Azzouzi R, Valéri A, Guillemin F, Fournier G, Cussenot O, Mangin P, Cormier L. Adherence to an annual PSA screening program over 3 years for brothers and sons of men with prostate cancer. Eur Urol. 2004 Mar;45(3):280-5; author reply 285-6. — View Citation

Rouprêt M, Fromont G, Bitker MO, Gattegno B, Vallancien G, Cussenot O. Outcome after radical prostatectomy in young men with or without a family history of prostate cancer. Urology. 2006 May;67(5):1028-32. — View Citation

Rouprêt M, Hupertan V, Yates DR, Catto JW, Rehman I, Meuth M, Ricci S, Lacave R, Cancel-Tassin G, de la Taille A, Rozet F, Cathelineau X, Vallancien G, Hamdy FC, Cussenot O. Molecular detection of localized prostate cancer using quantitative methylation-s — View Citation

Thomas G, Jacobs KB, Yeager M, Kraft P, Wacholder S, Orr N, Yu K, Chatterjee N, Welch R, Hutchinson A, Crenshaw A, Cancel-Tassin G, Staats BJ, Wang Z, Gonzalez-Bosquet J, Fang J, Deng X, Berndt SI, Calle EE, Feigelson HS, Thun MJ, Rodriguez C, Albanes D, — View Citation

Thuret R, Chantrel-Groussard K, Azzouzi AR, Villette JM, Guimard S, Teillac P, Berthon P, Houlgatte A, Latil A, Cussenot O. Clinical relevance of genetic instability in prostatic cells obtained by prostatic massage in early prostate cancer. Br J Cancer. 2 — View Citation

Valeri A, Briollais L, Azzouzi R, Fournier G, Mangin P, Berthon P, Cussenot O, Demenais F. Segregation analysis of prostate cancer in France: evidence for autosomal dominant inheritance and residual brother-brother dependence. Ann Hum Genet. 2003 Mar;67(P — View Citation

Valeri A, Cormier L, Moineau MP, Cancel-Tassin G, Azzouzi R, Doucet L, Baschet F, Cussenot I, L'Her J, Berthon P, Mangin P, Cussenot O, Morin JF, Fournier G. Targeted screening for prostate cancer in high risk families: early onset is a significant risk f — View Citation

Valeri A, Fournier G, Morin V, Morin JF, Drelon E, Mangin P, Teillac P, Berthon P, Cussenot O. Early onset and familial predisposition to prostate cancer significantly enhance the probability for breast cancer in first degree relatives. Int J Cancer. 2000 — View Citation

Yeager M, Chatterjee N, Ciampa J, Jacobs KB, Gonzalez-Bosquet J, Hayes RB, Kraft P, Wacholder S, Orr N, Berndt S, Yu K, Hutchinson A, Wang Z, Amundadottir L, Feigelson HS, Thun MJ, Diver WR, Albanes D, Virtamo J, Weinstein S, Schumacher FR, Cancel-Tassin — View Citation

Yeager M, Orr N, Hayes RB, Jacobs KB, Kraft P, Wacholder S, Minichiello MJ, Fearnhead P, Yu K, Chatterjee N, Wang Z, Welch R, Staats BJ, Calle EE, Feigelson HS, Thun MJ, Rodriguez C, Albanes D, Virtamo J, Weinstein S, Schumacher FR, Giovannucci E, Willett — View Citation

* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance of genetic and molecular factors in predicting the risk of prostate cancer	Logistic regression and artificial neural networks will be used	20 years	No

External Links

•   website from the sponsor which contains a description of the ProGene study and the associated publications