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The Predictive Value of Coexisting TMPRSS2-ERG Gene Fusion and PTEN Deletion in Prostate Cancer Patients With Biochemical Failure Status Post Salvage or Radical Radiation Therapy

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ClinicalTrials.gov Identifier: NCT02573636
Recruitment Status : Recruiting
First Posted : October 12, 2015
Last Update Posted : October 20, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Tamim Niazi, Sir Mortimer B. Davis - Jewish General Hospital

Study Description
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Brief Summary:
The objective of the study is to evaluate the predictive value of TMPRSS2-ERG gene fusion and PTEN in patients with high risk prostate cancer treated with first line LHRH agonist after biochemical failure.

Condition or disease
Prostate Cancer

Detailed Description:

The objective of the study is to evaluate the predictive value of TMPRSS2-ERG gene fusion and PTEN in patients with high risk prostate cancer treated with first line LHRH agonist after biochemical failure.

Patients in this study will be treated with standard hormonal treatment. Patients will remain on treatment regardless of rising PSA. PSA, other systemic therapy maybe added and the patients with oligometastasis could be treated with radiation therapy; this would be at the discretion of the treating oncologist.

The primary endpoint of this study is to determine the predictive value of TMPRSS2-ERG gene fusion and PTEN in hormonal refractory free survival and clinical progression rate in three years. The secondary endpoints are to evaluate the relation between Gleason score and TMPRSS2-ERG gene fusion and PTEN independently and together, the relation between T stage and TMPRSS2-ERG gene fusion and PTEN independently and together, and to determine the association of these markers with overall survival.

Study Design
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Study Type : Observational
Estimated Enrollment : 208 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Predictive Value of Coexisting TMPRSS2-ERG Gene Fusion and PTEN Deletion in Prostate Cancer Patients With Biochemical Failure Status Post Salvage or Radical Radiation Therapy
Actual Study Start Date : March 2016
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : March 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Number of patients with biochemical failure showing coexistence of PTEN and TMPRSS2-ERG gene fusion. [ Time Frame: recruitment over 4 years ]
    Biopsy samples of patients treated for high risk prostate cancer with radical radiation and hormonal therapy (LHRH) who have either clinical progression or 3-year hormonal refractory free survival will be tested to evaluate the predictive value of the coexistence of 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 LHRH refractoriness


Biospecimen Retention:   Samples With DNA
Areas of prostate tumor will be identified by the pathologist of the study. This will then be excised from the paraffin block using a tissue microarray punch. Two punches will be acquired: one for RNA extraction and one for DNA extraction. RNA and DNA will be extracted using the RecoverAll Nucleic Acid Isolation Kit (Ambion). Standard protocol for the isolation of nucleic acids will be used differing only in the time of protease digestion such that RNA is isolated after a short incubation (30 minutes), while DNA is isolated after a longer incubation (overnight). DNA will be used to assess copy number variation at the PTEN locus (10q23) using quantitative PCR and appropriate Taqman chemistry.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The original slides of 208 patients with informed consent will be reviewed. Patients with and without markers under the investigation will be accrued into this study. The investigators at the treating institutions will submit paraffin-embedded tissue blocks from the original pre-treatment diagnostic prostatic biopsy, which will be reviewed to confirm the Gleason score and to record other histopathologic features, such as the extent of tumor in the biopsies, the number of positive biopsies, and mitotic index.
Criteria

Inclusion Criteria:

  • T3a +
  • PSA > 20
  • Gleason 8 or higher
  • Karnofsky performance status ≥ 70.
  • Signed study-specific informed consent

Exclusion Criteria:

-

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02573636


Contacts
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Contact: Ashley Feng, M.Sc. 514-340-8222 ext 26510 yanqi.feng.ccomtl@ssss.gouv.qc.ca

Locations
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Canada, Quebec
CIUSSS du Saguenay-Lac-St-Jean/CSSS de Chicoutimi Recruiting
Chicoutimi, Quebec, Canada, G7H 5H6
Principal Investigator: Hugo Villeneuve, MD         
CISSS de la Montérégie-Centre - Hôpital Charles-LeMoyne Recruiting
Greenfield Park, Quebec, Canada, J4V 2H1
Contact: Genevieve Bujold         
Principal Investigator: Marjorie Jolicoeur, MD         
CISSS de Laval - Hôpital de la Cité-de-la-santé de Laval Recruiting
Laval, Quebec, Canada, H7M 3L9
Contact: Solange Tremblay         
Principal Investigator: Levon Igidbashian, MD         
CIUSSS de l'Est-de-l'Île-de-Montréal - Hôpital Maisonneuve-Rosemont Recruiting
Montreal, Quebec, Canada, H1T 2M4
Contact: Josée Abi-Saad         
Principal Investigator: Peter Vavassis, MD         
Jewish General Hospital, McGill University Recruiting
Montreal, Quebec, Canada, H3T 1E2
Contact: Ashley Feng, M.Sc.    514-340-8222 ext 26510    yanqi.feng.ccomtl@ssss.gouv.qc.ca   
Principal Investigator: Tamim Niazi, MD         
MUHC - Cedars Cancer Center Recruiting
Montreal, Quebec, Canada, H4A 3J1
Contact: Marianna Perna         
Principal Investigator: Luis Souhami, MD         
CIUSSS de l'Estrie - Hôpital Fleurimont Not yet recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Contact: Sophie Couture         
Principal Investigator: Abdenour Nabid, MD         
CIUSSS de la Mauricie-et-du-centre-du Quebec - Centre hospitalier régional de Trois-Rivières Recruiting
Trois-Rivières, Quebec, Canada, G8Z 3R9
Contact: Marie-Eve Caron         
Principal Investigator: Linda-Suzanne Vincent, MD         
Canada
CHU - L'Hôtel-Dieu de Québec Recruiting
Quebec, Canada, G1R 2J6
Contact: Josée Allard         
Principal Investigator: André-Guy Martin, MD         
Sponsors and Collaborators
Sir Mortimer B. Davis - Jewish General Hospital
More Information
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Responsible Party: Dr. Tamim Niazi, Principal investigator, Sir Mortimer B. Davis - Jewish General Hospital
ClinicalTrials.gov Identifier: NCT02573636    
Other Study ID Numbers: PCS VIII
First Posted: October 12, 2015    Key Record Dates
Last Update Posted: October 20, 2020
Last Verified: October 2020
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases