Prostate Cancer (Adenocarcinoma)LUDOPATHNCT07370597
LUtetium-177 DOsimetry as a Predictive Biomarker of Response in Metastatic Prostate Cancer Patients Treated With PSMA Radioligand THerapy.
An observational study of Prostate Cancer (Adenocarcinoma), run by Jules Bordet Institute at 1 site in Belgium.
Trial summary
A substantial proportion of patients with mCRPC do not respond to 177Lu-PSMA-RLT. The PSA response to Lu-PSMA was observed in nearly 46% of patients included in VISION trial and 66% in LuPSMA trial (4,5). The response to treatment can be evaluated after two cycles using the PSA or PSMA PET/CT scan. Gafita et al. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer (Adenocarcinoma)
- How many people
- 110 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Feb 2026to 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Progressive metastatic prostate cancer
Who may be able to join
- Male aged ≥18 years with adenocarcinoma of the prostate.
- Progressive metastatic prostate cancer (progression defined as two consecutive increases of PSA, or progression by bone scan or by RECIST1.1).
- Candidate for 177Lu-PSMA-RLT, with at least one lesion showing significant PSMA uptake (uptake higher than liver physiologic activity).
- Able to start treatment within four weeks of baseline PSMA PET/CT.
- Willing and able to comply with all study requirements
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Institut Jules Bordet
Brussels, 1070
Loubna TARAJI, MS, 0032497137249, loubna.taraji@hubruxelles.be
About this study
A substantial proportion of patients with mCRPC do not respond to 177Lu-PSMA-RLT. The PSA response to Lu-PSMA was observed in nearly 46% of patients included in VISION trial and 66% in LuPSMA trial (4,5). The response to treatment can be evaluated after two cycles using the PSA or PSMA PET/CT scan. Gafita et al. Data have shown that PSA and PSMA perform equally in assessing response to 177Lu-PSMA treatment, and their changes after two cycles are related to patient survival. After two cycles, patients with no PSA or PSMA response had worse outcomes than those with partial response or stable disease . That means PSA and PSMA changes after two cycles can be used as a surrogate of patient outcome. However, the explanation of disease resistance to 177Lu-PSMA-RLT is not yet fully understood. Inappropriate dose administration might be one of the possible explanations. A dose-response relationship has been established in radiotherapy , making dosimetry a standard of care in conventional radiotherapy. In the radionuclide therapy settings, the dose-response relationship has been reported in a multi-center phase 2 trial on the selective internal radiotherapy in hepatocellular carcinoma. In this context, calculating the absorbed dose to tumour lesions could be an excellent method to individualize radionuclide therapy to achieve a maximal response to treatment. If dosimetry calculations could predict which patients would ultimately respond or not respond to treatment, administered dose and number of 177Lu-PSMA-RLT cycles could be adapted early during the treatment course. In this context, our study aims to analyze if absorbed tumour dose obtained by dosimetry calculations could be used as a biomarker to predict non-response to treatment early after one cycle, as the first step towards treatment dose adaptation of a personalized radionuclide treatment approach.
- Conditions
- Prostate Cancer (Adenocarcinoma)
- Medical subject headings
- Prostatic Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| eligible patient will perform SPECT/CT and PSMA PET/CT imaging as per local routin | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-based response defined as a decline of serum PSA ≥50% at 12th weeks (after 2 cycles) after treatment initiation.
Measured: 12th week after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start1 Feb 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer (Adenocarcinoma)Studies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jules Bordet Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07370597
- Sponsor's protocol ID
- IJB-MN-LUDOPATH
- Acronym
- LUDOPATH
- Status last verified
- Jan 2026
- First submitted
- 19 Jan 2026
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LUtetium-177 DOsimetry as a Predictive Biomarker of Response in Metastatic Prostate Cancer Patients Treated With PSMA Radioligand THerapy.
- ClinicalTrials.gov ID
- NCT07370597
- Acronym / sponsor ID
- LUDOPATH / IJB-MN-LUDOPATH
- Conditions
- Prostate Cancer (Adenocarcinoma)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Jules Bordet InstituteUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 27 Jan 2026 (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.
A substantial proportion of patients with mCRPC do not respond to 177Lu-PSMA-RLT. The PSA response to Lu-PSMA was observed in nearly 46% of patients included in VISION trial and 66% in LuPSMA trial (4,5). The response to treatment can be evaluated after two cycles using the PSA or PSMA PET/CT scan. Gafita et al. Data have shown that PSA and PSMA perform equally in assessing response to 177Lu-PSMA treatment, and their changes after two cycles are related to patient survival. After two cycles, patients with no PSA or PSMA response had worse outcomes than those with partial response or stable disease . That means PSA and PSMA changes after two cycles can be used as a surrogate of patient outcome. However, the explanation of disease resistance to 177Lu-PSMA-RLT is not yet fully understood. Inappropriate dose administration might be one of the possible explanations. A dose-response relationship has been established in radiotherapy , making dosimetry a standard of care in conventional radiotherapy. In the radionuclide therapy settings, the dose-response relationship has been reported in a multi-center phase 2 trial on the selective internal radiotherapy in hepatocellular carcinoma. In this context, calculating the absorbed dose to tumour lesions could be an excellent method to individualize radionuclide therapy to achieve a maximal response to treatment. If dosimetry calculations could predict which patients would ultimately respond or not respond to treatment, administered dose and number of 177Lu-PSMA-RLT cycles could be adapted early during the treatment course. In this context, our study aims to analyze if absorbed tumour dose obtained by dosimetry calculations could be used as a biomarker to predict non-response to treatment early after one cycle, as the first step towards treatment dose adaptation of a personalized radionuclide treatment approach.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| eligible patient will perform SPECT/CT and PSMA PET/CT imaging as per local routin | – | – |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Progressive metastatic prostate cancer
Key inclusion criteria (5 listed)
- Male aged ≥18 years with adenocarcinoma of the prostate.
- Progressive metastatic prostate cancer (progression defined as two consecutive increases of PSA, or progression by bone scan or by RECIST1.1).
- Candidate for 177Lu-PSMA-RLT, with at least one lesion showing significant PSMA uptake (uptake higher than liver physiologic activity).
- Able to start treatment within four weeks of baseline PSMA PET/CT.
- Willing and able to comply with all study requirements
Key exclusion criteria (0 listed)
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
Patient-based response defined as a decline of serum PSA ≥50% at 12th weeks (after 2 cycles) after treatment initiation.
Time frame: 12th week after treatment initiation
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 27 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
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 (Adenocarcinoma), run by Jules Bordet Institute at 1 site in Belgium.
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 5 inclusion and 0 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 27 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 Belgium. 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 Carlos Artigas, MD (02.54137.81, carlos.artigas@hubruxelles.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-based response defined as a decline of serum PSA ≥50% at 12th weeks (after 2 cycles) after treatment initiation. (time frame: 12th week after treatment initiation). 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 27 Jan 2026.