Assessing DNA Changes in High Risk Prostate Cancer to Determine Prognosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Sir Mortimer B. Davis - Jewish General Hospital
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Dr. Tamim Niazi, Sir Mortimer B. Davis - Jewish General Hospital
ClinicalTrials.gov Identifier:
NCT01350180
First received: April 26, 2011
Last updated: August 6, 2014
Last verified: August 2014
  Purpose

One of the biggest problems facing prostate cancer patients and their treating physicians is who needs to be treated and when. Common clinical and pathological parameters are useful (PSA, Gleason score, etc.) but do not clearly predict who will benefit from treatment and who will fail. Genetic markers for tumor aggressivity would be of greater value. The finding that the TMPRSS2-ERG gene fusion is associated with an increase risk of cancer progression is important. TMPRSS2 is controlled by androgen (testosterone) and ERG is part of a family of proteins which have a role in controlling cell growth, cell specialization and producing tumors. As a consequence of this gene fusion, production of the ERG protein increases in the presence of testosterone and could be key to the development of prostate cancer, resistance to treatment and poor outcome. The PTEN gene is known to have a role as a tumor suppressor. Its deletion is a contributing factor in the development of prostate cancers and poor outcome. The coexistence of the two markers could be associated with a higher risk of recurrence.

To date there have been no studies regarding the presence of either of these two markers or their coexistence in high risk prostate cancer patients who, despite radiation therapy and androgen suppression, develop biochemical failure (their PSA levels rise once again). Patients participating in the PCS IV study (high risk prostate cancer treated with radiation therapy plus either 18 or 36 months of hormonal suppression) who have had biochemical failure or 3 years of follow-up post hormonal therapy will be approached.

Tumor blocks from consenting patients will be collected and analyzed for the presence of the TMPRSS2-ERG gene fusion and the PTEN deletion at the Pathology Department of the Jewish General Hospital. Statistical analysis will be carried out to see whether either or both markers are present, whether they are associated with certain clinical and pathological high risk factors, and whether they can be used to predict which patients will fail treatment.


Condition
Prostate Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Study Assessing the Predictive Value of TMPRSS2-ERG Gene Fusion and PTEN Deletion in High Risk Prostate Cancer Patients

Resource links provided by NLM:


Further study details as provided by Sir Mortimer B. Davis - Jewish General Hospital:

Primary Outcome Measures:
  • number of patients with biochemical failure showing the TMPRSS2-ERG gene fusion and/or PTEN deletion [ Time Frame: recruitment over 2 years ] [ Designated as safety issue: No ]
    biopsy samples of patients treated for high risk prostate cancer with radical radiation and hormonal therapy who have either biochemical failure or 3-year post treatment follow-up free of cancer recurrences will be tested for the TMPRSS2-ERG gene fusion and the PTEN deletion. The results between the two groups will be compared to see if either DNA changes are an indicator of disease recurrence.


Estimated Enrollment: 132
Study Start Date: September 2010
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

high risk prostate cancer patients having received radical radiation and hormonal therapy in either biochemical failure or 3-year post end of hormonal therapy

Criteria

Inclusion Criteria:

  • patients with prostate cancer post radical radiation therapy and LHRH agonist treated in PCSIV clinical trial
  • biochemical failure (PSA nadir + 2) or minimum follow-up of 3 years post completion of hormonal therapy
  • high risk group

    1. gleason score 8-10
    2. PSA ≥ 20 ng/ml
    3. T3 or T4
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01350180

Locations
Canada, Quebec
Hôpital de Gatineau Recruiting
Gatineau, Quebec, Canada
Contact: C Normand    819-561-8100      
Principal Investigator: R Archambault         
Jewish General Hospital Recruiting
Montreal, Quebec, Canada
Contact: B Fournier    514-340-8288      
Principal Investigator: T Niazi         
CHUM-Notre- Dame Recruiting
Montreal, Quebec, Canada
Contact: C Lafleur    514-890-8000      
Principal Investigator: J-P Guay         
Hôpital Maisonneuve-Rosemont Recruiting
Montreal, Quebec, Canada
Contact: L Roy-Huneault    514-252-3400      
Principal Investigator: C Lemaire         
Montreal General Hospital Recruiting
Montreal, Quebec, Canada
Contact: M Oerna    514-934-1934      
Principal Investigator: L Souhami         
CHUS - Hôpital Fleurimont - Sherbrooke Recruiting
Sherbrooke, Quebec, Canada
Contact: S Couture    819-346-1110      
Principal Investigator: A Nabid         
Centre Hospitalier régional de Trois-Rivières Recruiting
Trois-Rivières, Quebec, Canada
Contact: M Caron    819-697-3333      
Principal Investigator: F Vincent         
Canada
CHUQ, L'Hôtel-Dieu de Québec Recruiting
Quebec, Canada
Contact: J Allard    418-525-4444      
Principal Investigator: A-G Martin         
Sponsors and Collaborators
Dr. Tamim Niazi
AstraZeneca
  More Information

No publications provided

Responsible Party: Dr. Tamim Niazi, Radiation Oncologist, Sir Mortimer B. Davis - Jewish General Hospital
ClinicalTrials.gov Identifier: NCT01350180     History of Changes
Other Study ID Numbers: MP-JGH-10-032
Study First Received: April 26, 2011
Last Updated: August 6, 2014
Health Authority: Canada: Health Canada

Keywords provided by Sir Mortimer B. Davis - Jewish General Hospital:
biochemical failure
hormonal therapy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on September 18, 2014