Evaluating imaging response biomarkers in advanced prostate cancer treatment
Prospective Evaluation of Imaging Response Biomarkers During [177Lu]Lu-PSMA in Metastatic Castration-resistant Prostate Cancer
This study is testing a new imaging method to see if a specific treatment for advanced prostate cancer can help doctors spot tumor growth early and adjust treatment when needed.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University Hospital, Grenoble Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Grenoble) |
| Trial ID | NCT06828263 on ClinicalTrials.gov |
What this trial studies
This study focuses on the use of Lutetium-177 prostate-specific membrane antigen ([177Lu]Lu-PSMA) in patients with metastatic castration-resistant prostate cancer (mCRPC). It aims to assess imaging response biomarkers to identify tumor progression early, potentially allowing for timely changes in treatment. The study utilizes the Response Evaluation Criteria in PSMA-imaging (RECIP) to evaluate therapeutic efficacy through PSMA-PET/CT imaging after initial treatment cycles. By monitoring these biomarkers, the study seeks to improve patient care and reduce unnecessary therapies.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 or older with progressive mCRPC who have previously undergone anti-androgen therapy and have a performance status of 0 to 2.
Not a fit: Patients who are opposed to the use of their data for clinical research will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier detection of tumor progression, allowing for more effective treatment adjustments and improved patient outcomes.
How similar studies have performed: Other studies have shown promise in using imaging biomarkers for treatment evaluation in prostate cancer, indicating that this approach has potential based on prior successes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult aged 18 or older with proven adenocarcinoma of the prostate * Diagnosis of progressive metastatic castration-resistant prostate cancer. * Progression or intolerance on a novel anti-androgen therapy (i.e. abiraterone, enzalutamide, apalutamide or darolutamide) * Prior therapy with at least one taxane-based chemotherapy during the course of prostate cancer or the patient is symptomatic and assessed as unfit for chemotherapy. * ECOG Performance status 0 to 2 Exclusion Criteria: * Patient opposed to the use of his data for clinical research.
Where this trial is running
Grenoble
- CHU Grenoble Alpes — Grenoble, France (Recruiting)
Study contacts
- Study coordinator: Loïc DJAÏLEB, PU-PH
- Email: ldjaileb@chu-grenoble.fr
- Phone: 04 76 76 54 55
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.