Stichting Katholieke Universiteit, the University Medical Centre Nijmegen

Gen-probe, Inc.

Stichting Katholieke Universiteit

Stichting Katholieke Universiteit, More Particularly the University Medical Centre Nijmegen

Gerald Verhaegh

Jack A Schalken

Daphne Hessels

J Alfred Witjes

Marion J Bussemakers

Alfred J Witjes

Frank Smit

Alfred J Dept Of Exp Urology Witjes

Described herein are method, compositions and kits for prognosis of prostate cancer. The methods include determining the ratio of PCA3 and of a prostate-specific marker expression in a urine sample and correlating the value of the PCA3/prostate-specific marker ratio with the aggressiveness and mortality risk of prostate cancer in the subject. The method for prognosing prostate cancer in a sample of a patient includes assessing the amount of a prostate cancer specific PCA3 mRNA and the amount of prostate-specific marker in the sample; determining a ratio value of this amount of prostate cancer specific PCA3 mRNA over the amount of prostate-specific marker; comparing the ratio value to at least one predetermined cut-off value, wherein a ratio value above the predetermined cut-off value is indicative of a higher risk of mortality of prostate cancer as compared to a ratio value below the predetermined cut-off value.

Prostate cancer prognostic compositions and kits

Described herein are methods and kits for prognosis of prostate cancer in a subject. The methods comprises: (a) determining the ratio of PCA3 and of a prostate-specific marker expression in a urine sample and (b) correlating the value of the PCA3/prostate-specific marker ratio with the aggressiveness and mortality risk of prostate cancer in the subject. Kits for prognosing prostate cancer are also described. More particularly, the present invention features a method for prognosing prostate cancer in a biological sample of a patient comprising: assessing the amount of a prostate cancer specific PCA3 mRNA and the amount of prostate-specific marker in the biological sample; determining a ratio value of this amount of prostate cancer specific PCA3 mRNA over the amount of prostate-specific marker; comparing the ratio value to at least one predetermined cut-off value, wherein a ratio value above the predetermined cut-off value is indicative of a higher risk of mortality of prostate cancer as compared to a ratio value below the predetermined cut-off value.

mRNA ratios in urinary sediments and/or urine as a prognostic and/or theranostic marker for prostate cancer

Described herein are methods and kits for prognosis of prostate cancer in a subject. The methods comprises: (a) determining the ratio of PCA3 and PSA expression in a urine sample and (b) correlating the value of the PCA3/PSA ratio with the aggressiveness and mortality risk of prostate cancer in the subject. Kits for prognosing prostate cancer are also described. More particularly, the present invention features a method for prognosing prostate cancer in a biological sample of a patient comprising: assessing the amount of a prostate cancer specific PCA3 mRNA and the amount of PSA in the biological sample; determining a ratio value of this amount of prostate cancer specific PCA3 mRNA over the amount of PSA; comparing the ratio value to at least one predetermined cut-off value, wherein a ratio value above the predetermined cut-off value is indicative of a higher risk of mortality of prostate cancer as compared to a ratio value below the predetermined cut-off value.

This invention describes the cloning and characterization of the promoter region for the PCA3gene. This region regulates the PCA3gene expression by a unique prostate specific transcriptional mechanism. The present invention relates to the use of this promoter region as a tool for prostate cancer treatment and diagnosis and screening of agents which regulate expression of PCA3. In a particular embodiment, the present invention relates to an isolated promoter sequence which comprises an isolated promoter sequence which comprises a sequence as set forth between nucleotide positions 372 to 460 of SEQ ID NO:1, this sequence enabling a prostate-specific modulation of transcription.

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Maden, Netherlands

Gerald Verhaegh