Prostate Cancer MetastaticLUTRACNCT06260410
Data Collection in Lutetium Treated Prostate Cancer: Recording of Progression and Tumor Characteristics
An observational study of Prostate Cancer Metastatic, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
This prospective study aims to collect data and blood biomarkers from patients undergoing Lu-PSMA therapy at the Erasmus MC. In doing so, it will provide real-world efficacy and safety data on the drug, gather dosimetry data and explore putative biomarkers to identify patients who most benefit from Lu-PSMA treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer Metastatic
- What is being tested?
- Blood draw for ctDNA and circulating tumor cell collection.
- How many people
- 150 participants
- Where
- 1 siteNetherlands
- Study dates
- 20 Feb 2024to 1 Feb 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 diagnosed with metastatic castration resistant prostate cancer set to receive treatment with Lutetium-177 Prostate Specific Membrane Antigen (Lu-PSMA) as a part of regular clinical care.
Who may be able to join
- Participants should be at least 18 years old.
- Participants should be able to understand the written information and be able to provide informed consent.
- Participants are planned to start treatment with Lu-PSMA as a part of regular clinical care.
Who cannot join
- None applicable
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus MC
Rotterdam, South Holland, 3015 CN
Stijn Koolen, PhD, +31638740656, s.koolen@erasmusmc.nl
About this study
This prospective study aims to collect data and blood biomarkers from patients undergoing Lu-PSMA therapy at the Erasmus MC. In doing so, it will provide real-world efficacy and safety data on the drug, gather dosimetry data and explore putative biomarkers to identify patients who most benefit from Lu-PSMA treatment.
- Conditions
- Prostate Cancer Metastatic
- Being tested
- Blood draw for ctDNA and circulating tumor cell collection.
- Keywords
- mCRPC, Lu-PSMA, Prostate Cancer, Radioligand Therapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood draw for ctDNA and circulating tumor cell collection.Diagnostic test
During routine blood sample collection, additional blood will be drawn for analysis of ctDNA and to collect Circulating Tumor Cells.
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Overall survival will be defined as the time from inclusion to death from any cause.
Measured: 44 months
Secondary outcomes (5)
Progression free survival
Progression free survival will be defined as clinical, radiological or PSA progression according to Prostate Cancer Working Group 3 (PCWG3) or death, whichever occurs first.
Measured: 44 months
Heterogeneity of PSMA-positivity
Exploring heterogeneity of PSMA-positivity in circulating tumor cells (CTC) prior to treatment with Lutetium-PSMA.
Measured: 44 months
Effect of CTC PSMA expression on response to treatment.
Exploring whether there is an association between the fraction of PSMA positive CTCs and response to Lutetium-PSMA treatment.
Measured: 44 months
Effect of biomarkers in blood on response to treatment.
Exploring the association between biomarkers in blood and response to treatment
Measured: 44 months
PSMA-PET scan data and response to treatment.
Exploring associations between PSMA-PET and therapy scans and response to treatment.
Measured: 44 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start20 Feb 2024
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 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 MetastaticStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, S. L. W. (Stijn) Koolen, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06260410
- Sponsor's protocol ID
- 10512
- Other IDs
- NL84672.078.23
- Acronym
- LUTRAC
- Status last verified
- Apr 2024
- First submitted
- 7 Feb 2024
- Last updated
- 22 Apr 2024
- 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 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Data Collection in Lutetium Treated Prostate Cancer: Recording of Progression and Tumor Characteristics
- ClinicalTrials.gov ID
- NCT06260410
- Acronym / sponsor ID
- LUTRAC / 10512
- Conditions
- Prostate Cancer Metastatic
- Keywords
- mCRPC, Lu-PSMA, Prostate Cancer, Radioligand Therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 15 Feb 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.
This prospective study aims to collect data and blood biomarkers from patients undergoing Lu-PSMA therapy at the Erasmus MC. In doing so, it will provide real-world efficacy and safety data on the drug, gather dosimetry data and explore putative biomarkers to identify patients who most benefit from Lu-PSMA treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with metastatic castration resistant prostate cancer set to receive treatment with Lutetium-177 Prostate Specific Membrane Antigen (Lu-PSMA) as a part of regular clinical care.
Key inclusion criteria (3 listed)
- Participants should be at least 18 years old.
- Participants should be able to understand the written information and be able to provide informed consent.
- Participants are planned to start treatment with Lu-PSMA as a part of regular clinical care.
Key exclusion criteria (1 listed)
- None applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood draw for ctDNA and circulating tumor cell collection.During routine blood sample collection, additional blood will be drawn for analysis of ctDNA and to collect Circulating Tumor Cells. | Diagnostic test | – |
Primary outcome
Overall survival
Time frame: 44 months
Overall survival will be defined as the time from inclusion to death from any cause.
5 secondary outcomes
Progression free survival
Time frame: 44 months
Heterogeneity of PSMA-positivity
Time frame: 44 months
Effect of CTC PSMA expression on response to treatment.
Time frame: 44 months
Effect of biomarkers in blood on response to treatment.
Time frame: 44 months
PSMA-PET scan data and response to treatment.
Time frame: 44 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 22 Apr 2024.
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RecruitingPhase 2
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
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ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
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Active, not recruitingPhase 2
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
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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 Metastatic, run by Erasmus Medical Center at 1 site in Netherlands.
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 3 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 22 Apr 2024. 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 Netherlands. 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 Stijn Koolen, PhD (+31638740656, s.koolen@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 44 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 22 Apr 2024.