Clinical and Dosimetric Study of Patients Treated With 177Lu-PSMA-617 for Prostate Cancer.
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorInstitut Bergonié
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient aged 18 and over.
Progressive, metastatic, castration-resistant prostate cancer,
overexpressing prostate specific membrane antigen (PSMA)
treated with taxane chemotherapy and at least one 2nd generation hormone therapy (apalutamide, enzalutamide, darolutamide, abiraterone-prednisone).
Disqualifiers
None
Trial population
Patients with metastatic castration-resistant prostate cancer.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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.Secondary outcomes
1
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.2
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.Sponsors and contacts
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Source ClinicalTrials.gov