Evaluating gene markers in prostate cancer after treatment failure
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
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 |
|---|---|
| Enrollment | 208 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Sir Mortimer B. Davis - Jewish General Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 9 sites (Chicoutimi, Quebec and 8 other locations) |
| Trial ID | NCT02573636 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with lower Gleason scores or those not meeting the specified PSA criteria may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Chicoutimi, Quebec and 8 other locations
- 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)
- CHU - L'Hôtel-Dieu de Québec — Québec, Quebec, Canada (Recruiting)
- CIUSSS de l'Estrie - Hôpital Fleurimont — Sherbrooke, Quebec, Canada (Not_yet_recruiting)
- CIUSSS de la Mauricie-et-du-centre-du Quebec - Centre hospitalier régional de Trois-Rivières — Trois-Rivières, Quebec, Canada (Recruiting)
Study contacts
- Study coordinator: Ashley Feng, M.Sc.
- Email: yanqi.feng.ccomtl@ssss.gouv.qc.ca
- Phone: 514-340-8222
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.