Evaluating gene markers in prostate cancer after treatment failure
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
Run by Sir Mortimer B. Davis - Jewish General Hospital · NCT02573636 · Data updated 2026-11-12
This study is testing if certain gene markers can help predict how well high-risk prostate cancer patients will respond to standard hormonal therapy after their initial treatment has failed.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Men only |
| Enrollment | 208 (estimated) |
| Sponsor | Sir Mortimer B. Davis - Jewish General Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 9 sites (Chicoutimi, Quebec and 8 other locations) |
| Status | Recruiting |
| Started | March 2016 |
| Main results expected | November 2026 |
| Study ends | March 2027 |
| Registry record updated | December 4, 2024 |
| Trial ID | NCT02573636 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include men with high-risk prostate cancer who have a PSA level greater than 20 and a Gleason score of 8 or higher.
✕Probably not a fit
Patients with lower Gleason scores or those not meeting the specified PSA criteria may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to assess the predictive value of the TMPRSS2-ERG gene fusion and PTEN deletion in patients with high-risk prostate cancer who have experienced biochemical failure after initial treatment. Participants will receive standard hormonal therapy, and their PSA levels will be monitored, with additional treatments considered based on clinical discretion. The primary goal is to determine how these genetic markers correlate with hormonal refractory free survival and clinical progression over three years, while secondary goals include examining relationships between Gleason scores, T stages, and overall survival.
Why it matters
Potential benefit: If successful, this study could help identify patients at higher risk for disease progression, allowing for more tailored treatment strategies.
How similar studies have gone: While the predictive value of TMPRSS2-ERG and PTEN has been explored in other contexts, this specific evaluation in the setting of biochemical failure post-treatment is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * T3a + * PSA \> 20 * Gleason 8 or higher * Karnofsky performance status ≥ 70. * Signed study-specific informed consent Exclusion Criteria: \-
Where it's running
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CIUSSS du Saguenay-Lac-St-Jean/CSSS de Chicoutimi
Chicoutimi, Quebec, Canada Recruiting -
CISSS de la Montérégie-Centre - Hôpital Charles-LeMoyne
Greenfield Park, Quebec, Canada Recruiting -
CISSS de Laval - Hôpital de la Cité-de-la-santé de Laval
Laval, Quebec, Canada Recruiting -
CIUSSS de l'Est-de-l'Île-de-Montréal - Hôpital Maisonneuve-Rosemont
Montreal, Quebec, Canada Recruiting -
Jewish General Hospital, McGill University
Montreal, Quebec, Canada Recruiting -
MUHC - Cedars Cancer Center
Montreal, Quebec, Canada Recruiting
Show 3 more locations
-
CHU - L'Hôtel-Dieu de Québec
Québec, Quebec, Canada Recruiting -
CIUSSS de la Mauricie-et-du-centre-du Quebec - Centre hospitalier régional de Trois-Rivières
Trois-Rivières, Quebec, Canada Recruiting -
CIUSSS de l'Estrie - Hôpital Fleurimont
Sherbrooke, Quebec, Canada Not yet recruiting
Study contacts
- Study coordinator: Ashley Feng, M.Sc.
- Email: yanqi.feng.ccomtl@ssss.gouv.qc.ca
- Phone: 514-340-8222
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.