Dynamic 68Ga-PSMA and 18F-FDG PET/CT scans before 177Lu-PSMA treatment
Dynamic 68Ga-PSMA and 18F-FDG PET/CT Analysis of Metastatic Prostatic Adenocarcinomas Prior to 177Lu-PSMA Treatment
This will test whether dynamic 68Ga‑PSMA and 18F‑FDG PET/CT scans can better identify men with metastatic castration‑resistant prostate cancer who are likely to benefit from 177Lu‑PSMA therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Centre Henri Becquerel Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Rouen) |
| Trial ID | NCT06450548 on ClinicalTrials.gov |
What this trial studies
Patients with progressive metastatic castration‑resistant prostate cancer who have received taxane chemotherapy and at least one androgen‑receptor–targeted therapy undergo both dynamic 68Ga‑PSMA and 18F‑FDG PET/CT imaging prior to possible 177Lu‑PSMA treatment. The study uses parametric (dynamic) PET acquisition and kinetic analysis to compare tracer behavior across lesions and to detect FDG‑positive/PSMA‑negative sites associated with poorer prognosis. Investigators will compare dynamic parametric measures to standard imaging readouts to see if they improve lesion characterization and treatment selection. This single‑center study at Centre Henri Becquerel aims to inform which patients should be offered 177Lu‑PSMA therapy based on imaging biology.
Who should consider this trial
Good fit: Ideal candidates are men with histologically confirmed metastatic castration‑resistant prostate adenocarcinoma who have progressed after taxane chemotherapy and at least one anti‑androgen therapy and who can undergo both 68Ga‑PSMA and 18F‑FDG PET/CT scans.
Not a fit: Patients who cannot tolerate prolonged imaging sessions, cannot complete both PET/CT examinations, or who lack PSMA‑positive disease are unlikely to gain direct benefit from the imaging approach in this study.
Why it matters
Potential benefit: If successful, this approach could help doctors choose 177Lu‑PSMA therapy more accurately and avoid giving it to patients unlikely to benefit.
How similar studies have performed: Large trials like VISION have shown survival benefit for 177Lu‑PSMA‑617, but the use of dynamic parametric PET to better select patients is relatively novel with limited prior data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Signed informed consent. * Progressive metastatic castration-resistant prostate adenocarcinoma, which has been treated with taxane chemotherapy and at least one anti-androgen hormone therapy. * Evaluated by 18F-FDG and 68Ga-PSMA PET/CT prior to potential treatment with 177Lu-PSMA. * Affiliated with or beneficiary of a social protection scheme. * WHO stage 0 or 1. Exclusion Criteria: * Patients unable to understand the study for any reason or comply with the trial requirements (due to language barriers, psychological issues, geographical constraints, etc.). * Patients unable to undergo the examinations and/or maintain a prolonged lying position (due to back pain, etc.).
Where this trial is running
Rouen
- Centre Henri Becquerel — Rouen, France (Recruiting)
Study contacts
- Study coordinator: Pierre Decazes, MD,PhD
- Email: pierre.decazes@chb.unicancer.fr
- Phone: +3276673059
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.