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.

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorCentre Georges Francois Leclerc

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 177Lu-PSMA-617 PET scan

    Radiation

    Patients then begin their first course of treatment an average of 2 months after the 68Ga-PSMA-11 PET scan, with IVR usually divided into a total of 6 courses. During the first course of treatment, patients undergo an initial SPECT scan 5h (±1h) post-injection, and return to the nuclear medicine department for three further SPECT scans, at 24h, 4 days and 8 days post-injection.

Treatment groups

35 Participants
are divided into 1 treatment group
Group A: RIV treatment with 177Lu-PSMA-617.Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Study the correlation between pre- and post-treatment estimates of absorbed doses to organs at risk

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.

Time frame
During 12 months

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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