Prostate CancerDOSIPROSTATENCT06700057
Clinical and Dosimetric Study of Patients Treated With 177Lu-PSMA-617 for Prostate Cancer.
An observational study of Prostate Cancer and Metastasis, run by Institut Bergonié at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Metastasis
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2023to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with metastatic castration-resistant prostate cancer.
Who may be able to join
- Patient aged 18 and over.
- Patient with indication for or having started or completed treatment with 177Lu-PSMA-617 since 01/11/2023:
- 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).
- Patient able to lie still for 1 hour for image acquisition.
- Patient's place of residence < 2 hours' drive from the Institut Bergonié.
- Patient has not expressed any opposition to the use of his/her medical data for research purposes.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Institut Bergonie
Bordeaux, 33600
Nadège ANIZAN, n.anizan@bordeaux.unicancer.fr
Caroline LALET, c.lalet@bordeaux.unicancer.fr
About this study
Official title: Optimisation and Safety of an Innovative Nuclear Medicine Treatment: Clinical and Dosimetric Study of Patients Treated With 177Lu-PSMA-617 for Prostate Cancer.
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.
Read the detailed description
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.
- Conditions
- Prostate Cancer, Metastasis
- Keywords
- Radiopharmaceutical drug
- Medical subject headings
- Prostatic Neoplasms, Neoplasm Metastasis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From pre-treatment baseline to the end of treatment and after the end of treatment, i.e approximately 10 months.
Secondary outcomes (2)
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.
Measured: 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.
Measured: From pre-treatment baseline to the end of treatment (Dose) and at the end of treatment (bjective functional response), i.e approximately 10 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start1 Nov 2023
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Bergonié
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nadège ANIZAN, Study director, Institut Bergonié
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06700057
- Sponsor's protocol ID
- IB 2024 - DOSIPROSTATE
- Acronym
- DOSIPROSTATE
- Status last verified
- Jan 2026
- First submitted
- 19 Nov 2024
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimisation and Safety of an Innovative Nuclear Medicine Treatment: Clinical and Dosimetric Study of Patients Treated With 177Lu-PSMA-617 for Prostate Cancer.
- ClinicalTrials.gov ID
- NCT06700057
- Acronym / sponsor ID
- DOSIPROSTATE / IB 2024 - DOSIPROSTATE
- Conditions
- Prostate Cancer, Metastasis
- Keywords
- Radiopharmaceutical drug
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Institut BergoniéUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 21 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with metastatic castration-resistant prostate cancer.
Key inclusion criteria (8 listed)
- Patient aged 18 and over.
- Patient with indication for or having started or completed treatment with 177Lu-PSMA-617 since 01/11/2023:
- Patient able to lie still for 1 hour for image acquisition.
- Patient's place of residence < 2 hours' drive from the Institut Bergonié.
- Patient has not expressed any opposition to the use of his/her medical data for research purposes.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Median of total absorbed-dose of 177Lu-PSMA-617 at total tumor volume as a function of prostate-antigen specific (PSA) response
Time frame: From pre-treatment baseline to the end of treatment and after the end of treatment, i.e approximately 10 months.
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.
2 secondary outcomes
Median of total absorbed-dose of 177Lu-PSMA-617 at total tumor volume as a function of best overall response (RECIST v1.1)
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)))
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nadège ANIZAN study director
Institut Bergonié
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Metastasis, run by Institut Bergonié at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nadège ANIZAN (+33556333347, n.anizan@bordeaux.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median of total absorbed-dose of 177Lu-PSMA-617 at total tumor volume as a function of prostate-antigen specific (PSA) response (time frame: From pre-treatment baseline to the end of treatment and after the end of treatment, i.e approximately 10 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.