Status:
NOT_YET_RECRUITING
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.
Lead Sponsor:
Centre Georges Francois Leclerc
Conditions:
Patients With Metastatic Castration-resistant Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
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 tre...
Detailed Description
Internal vectored radiotherapy (IVRT) for mCPRCs is emerging as a new treatment line of choice. Radiolabeled molecules with a high affinity for PSMA have emerged as promising theranostic radiopharmace...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2027
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT06136377
Start Date
January 31 2024
End Date
January 31 2027
Last Update
November 18 2023
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