An observational study in Prostate Cancer and Metastasis, sponsored by Institut Bergonié. Recruiting at 1 site in France. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-30.
Sponsored by Institut Bergonié · Observational
Single-centre, retrospective and prospective observational study. This study aims to evaluate the dose delivered by radiation to the tumour and organs at risk, as a factor predicting response and the appearance of toxicities. Dosimetric calculations are made for each treatment using scintigraphic images acquired following injection of 177Lu-PSMA-617.
The management of patients and the administration of treatment with 177Lu-PSMA are carried out in the usual way in the nuclear medicine department of the Institut Bergonié, and are not modified in any way.
The treatment regimen is standard, with 6 cycles spaced 6 weeks apart at a fixed dose of 7.4 GBq. Patients are selected on the basis of a 68Ga-PSMA-11 PET/CT scan to assess whether PSMA is properly expressed.
Only data are collected for the study and they are derived from the usual management of patients treated with 177Lu-PSMA at the Institut Bergonié: information on the treatment, anatomical data and 177Lu-PSMA fixation in lesions and tissues, scintigraphic images acquired post-treatment, data on monitoring the effects of the treatment, 68Ga-PSMA PET/CT images.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 50 is below the median of 200 across 1,310 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Institut Bergonié is the lead sponsor of 119 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with metastatic castration-resistant prostate cancer.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patient with indication for or having started or completed treatment with 177Lu-PSMA-617 since 01/11/2023:
Exclusion Criteria:
None
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Median of total absorbed-dose of 177Lu-PSMA-617 at total tumor volume as a function of prostate-antigen specific (PSA) response
To assess the association between the total absorbed-dose of treatment at total tumor volume and the efficacy of treatment in terms of PSA response rate (PSA50-RR). PSA50-RR is defined by the proportion of patients with a decrease ≥ 50% in PSA concentration from pre-treatment baseline, confirmed by a subsequent PSA assessment performed at least 3 weeks later. Absorbed-dose of treatment at total tumor volume, expressed in Gray (Gy), is calculated for each course of 177Lu-PSMA-617 (every 6 weeks +/- 1 week) from SPECT/CT images acquired post administration with PlanetDose software (DOSIsoft). The total absorbed dose in Gray (Gy) is defined by the sum of absorbed doses over all courses of treatment performed.
Time frame: From pre-treatment baseline to the end of treatment and after the end of treatment, i.e approximately 10 months.
Median of total absorbed-dose of 177Lu-PSMA-617 at total tumor volume as a function of best overall response (RECIST v1.1)
To assess the association between the total absorbed-dose of treatment at total tumor volume and the efficacy of treatment in terms of best overall response according to RECIST v1.1. Best overall response is defined as the best response evaluated according to RECIST v1.1, observed between initiation and end of treatment. It is determined once all data for the same patient are known. Absorbed-dose of treatment at total tumor volume, expressed in Gray (Gy), is calculated for each course of 177Lu-PSMA-617 (every 6 weeks +/- 1 week) from SPECT/CT images acquired post administration with PlanetDose software (DOSIsoft). The total absorbed dose in Gray (Gy) is defined by the sum of absorbed doses over all courses of treatment performed.
Time frame: From pre-treatment baseline to the end of treatment and after the end of treatment, i.e approximately 10 months.
Median of total absorbed-dose of 177Lu-PSMA-617 at total tumor volume as a function of objective functional response (nuclear physician assessment)))
To assess the association between the total absorbed-dose of treatment at total tumor volume and the efficacy of treatment in terms of objective functional response on 68Ga-PSMA-11 PET, defined as complete response or partial response, based on image interpretation by the nuclear physician. Absorbed-dose of treatment at total tumor volume, expressed in Gray (Gy), is calculated for each course of 177Lu-PSMA-617 (every 6 weeks +/- 1 week) from SPECT/CT images acquired post administration with PlanetDose software (DOSIsoft). The total absorbed dose in Gray (Gy) is defined by the sum of absorbed doses over all courses of treatment performed.
Time frame: From pre-treatment baseline to the end of treatment (Dose) and at the end of treatment (bjective functional response), i.e approximately 10 months.
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