Abstract: The present invention relates, in general, to prostate cancer. More specifically, the present invention relates to a method to diagnose prostate cancer in a patient by detecting a PCA3 sequence, and more particularly a PCA3 RNA, the PCA3 sequence detected in a sample from the patient being specifically associated with prostate cancer. In a particular embodiment the method and kit enables an amplification of a PCA3 RNA through an exon-exon junction of a spliced PCA3 mRNA. The invention also related to methods and kits to detect such an amplified PCA3 RNA, using a probe which spans the amplified exon-exon junction. The invention also relates to kits containing nucleic acid primers and kits containing nucleic acid primers and nucleic acid probes to diagnose, assess, or prognose a human afflicted with prostate cancer. In particular the methods and kits are designed to detect a PCA3 RNA which lacks one intron or more, and in particular case is intron-less.

Abstract: This invention describes the cloning and characterization of the promoter region for the PCA3dd3 gene. This region regulates the PCA3dd3 gene 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.