Epidemiologic and Genetic Study on Familial Prostate Cancer

Официальное название

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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Performance of genetic and molecular factors in predicting the risk of prostate cancer [Срок оценки: 20 years]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 5 центров

• Department of Urology, CHU Angers — Angers
• Department of Urology, Hopital de la Cavale Blanche — Brest
• Department of Urology, CHU Dijon — Dijon
• Department of Urology, Hopital Pitié-Salpetriere — Paris
• Department of Urology, Hopital Tenon — Paris

Публикации

• 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. PMID 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, Auvine PMID 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. PMID 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 PMID 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. PMID 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, Y PMID 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. PMID 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. PMID 35652560

Идентификаторы

NCT: NCT01221168 · ProGene

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗