NF-kB : a prognostic marker of prostate cancer

Summary


	Quick description:		NF-kB predicts aggressiveness of prostate cancer to optimize therapy regimen. MoA : Detection of NF-kB in the nucleus where an increase correlates with the development of metastases. NF-kB antibodies are detected by immunohistochemistry on biopsy. Applications : Screening to determine the prognostic of prostate cancer; improves the predictive power when used in combination with other known prognostic markers such as Gleason grade, pathological stage and prostate specific antigen (PSA). PoP : Prediction of bone metastasis in a study of 30 radical prostatectomy specimens (BJU int, March 2003); A second study with 706 samples (Urological Association, Quebec, 2007); Ongoing validation supported by a MDEIE grant to prove the concept on samples from 2300 patients.
	Posted by:		CHUM
	Published:		9 November 2009
	File number:		VAL-693-CHUM
	Project Type:		In-Licensing Opportunity
	Primary sector:		Health and Life Sciences
	Seeking / Offering:		Collaboration or Partnership, Non-Exclusive Licensing, Exclusive Licensing
	Website:		visit website

Background

Prostate cancer is the most frequently diagnosed cancer and the third leading cause of death by cancer in North American men. Actually, 2 millions Americans are leaving with prostate cancer. Every year, 232 000 men will be diagnosed, 70 000 patients will require treatments following cancer relapse and 30 000 patients will die. Although most prostate cancers are diagnosed at an early stage of the disease, it is difficult to predict whether a clinically localized prostate cancer will remain latent or progress into an aggressive highly metastatic disease. Following radical prostatectomy (RP), it is still controversial whether immediate adjuvant treatment should be initiated in the presence of pathologically confirmed positive surgical margins. Several factors such as time to biochemical recurrence, net PSA level and positive margins after RP, PSA doubling time, and Gleason score have been identified as predictors of progression to metastasis disease. However, reliability on a large cohort and clinical utility has to be demonstrated since those markers often provide a moderately differentiated prognosis. Therefore, the identification of a reliable prognostic marker of biochemical recurrence will allow developing a risk-adjusted therapeutic approach.

Description

A prognostic test based on immunohistochemistry technique already available in general hospital setting. The kit allows the identification of Nuclear Factor Kappa B (NF-kB) in the nucleus of epithelial cells in PR or in prostate biopsy samples.

Advantages

- First confirmed and reliable biomarker of prostate cancer prognosis;

- Validation on 3 000 tissue micro-array samples;

- Test suitable for tissue or biopsy samples;

- Further on-going validation studies with important financial support from provincial government;

- Easy to use technology based on a recognized immuno histochemistry method.

Potential Applications

The NF-kB biomarker is a prognosis test suitable for prostate tissue specimens or biopsy samples analysis.

Prognosis: Following positive diagnostic, the test allow the identification of those patients with the most aggressive forms of prostate cancer in order to propose a more aggressive therapy, or avoid unnecessary treatment;

Disease monitoring: the test could be used to monitor disease progression in response to the chosen therapy;

Clinical trial patient selection: the stratification of patient cohorts in a clinical trial is important to identify target population. The test could be the basis for the population selection.

State of Development

The technology has been tested in two separate trials confirming a strong correlation between the formation of metastases and changes in nucleic NF-kB levels in prostate tissue.