Clinical trial · Interventional
Evaluation of the Concordance Between Pre-therapy Dosimetry Performed From 68Ga-PSMA-11 Dynamic PET and Post-treatment Dosimetry of 177Lu-PSMA-617 Vectorized Internal Radiotherapy in Patients With Metastatic Prostate Cancer Resistant to Hormonal Castration.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Patients undergo three diagnostic PET scans: 18F-FDG PET scan / 18F-Choline PET scan and 68Ga-PSMA PET scan. Following the diagnostic PET scans, and if patients' eligibility for 177Lu-PSMA-617 IVR treatment is confirmed, SPECT acquisitions will be performed during the first treatment course at 5h, 24h, 4 days and 8 days for dosimetric control. The patient will then return to the nuclear medicine department to undergo SPECT/CT (3 FOV) acquisitions using the same methods as those presented above and recommended in the standard management at : D+24h post-injection, D+4d post-injection and D+8d post-injection No further research-specific acts or procedures will be performed at the end of the first treatment course. Continuity of treatment will be carried out in accordance with standard management and treatment requirements and modalities, as will clinical, biological and radiological follow-up.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Patients With Metastatic Castration-resistant Prostate Cancer | Castration-Resistant Prostate Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 177Lu-PSMA-617 PET scan | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- RIV treatment with 177Lu-PSMA-617.
- interventionNames
- Radiation: 177Lu-PSMA-617 PET scan
Primary outcomes (1)
- measure
- Study the correlation between pre- and post-treatment estimates of absorbed doses to organs at risk
- timeFrame
- During 12 months
- description
- Pre-treatment absorbed dose estimates will be determined during 68Ga-PSMA-11 PET acquisitions. Post-treatment absorbed dose estimates will be determined using 177Lu-PSMA-617 SPECT acquisitions.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients over 18 with histologically proven metastatic prostate cancer treated with taxane chemotherapy plus at least one second-generation hormone therapy and resistant to hormonal castration (eligibility criterion for 177Lu-PSMA IVR treatment). * Patient referred to CGFL for standard disease management with indication for 18F-FDG PET, 18F-Choline PET and 68Ga-PSMA-11 PET to validate patient's eligibility for 177Lu-PSMA-617 IVR treatment. * ECOG ≤ 2 * Life expectancy ≥ 6 months * No unacceptable medical or radiological risk for isolation in a nuclear medicine therapy unit. * Patient informed about the study, able to understand the study constraints and sign the consent form. * Patient affiliated to the social security system or equivalent Exclusion Criteria: * Inability of the patient to maintain a lying position, without moving, for more than 1 hour (1 hour 20 minutes of acquisition for the dynamic PET acquisition specific to the GaLuPro study). * Allergy to 68Ga-PSMA-11 or 177Lu-PSMA-617 * Contraindications to receiving 177Lu-PSMA IVR treatment and/or performing the imaging tests required by the protocol (patient with pacemaker or defibrillator). * Urinary tract obstruction or hydronephrosis. Patients with a diagnosis or high risk of urinary retention and/or fitted with a urinary catheter and/or with incontinence making urine collection impossible or PET examinations impossible. * Patient refusal to participate in study * Impossibility for the patient to undergo medical monitoring and compliance with treatment and trial procedures for geographical, social or psychological reasons. * Persons deprived of their liberty or under guardianship (including curatorship)
References
Publications (0)
Data not yet available