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
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Condition or disease |
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Prostate Cancer |
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 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 |

- 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

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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 |
Inclusion Criteria:
- T3a +
- PSA > 20
- Gleason 8 or higher
- Karnofsky performance status ≥ 70.
- Signed study-specific informed consent
Exclusion Criteria:
-

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
Contact: Ashley Feng, M.Sc. | 514-340-8222 ext 26510 | yanqi.feng.ccomtl@ssss.gouv.qc.ca |
Canada, Quebec | |
CIUSSS du Saguenay-Lac-St-Jean/CSSS de Chicoutimi | Recruiting |
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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 |
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 |
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms |
Neoplasms by Site Neoplasms Prostatic Diseases |