Prostate Cancer Metastatic Castration-ResistantLOOPSNCT07118436
Liquid Biopsy Under PSMA Radioligand Therapy
An observational study of Prostate Cancer Metastatic Castration-Resistant and Prostate Cancer, run by Wuerzburg University Hospital at 3 sites in Germany.
Trial summary
Prostate cancer is the second most common cause of cancer death in men worldwide. After exhausting guideline-compliant therapies or in accordance with the approval of 177Lu-PSMA-617 (Pluvicto®), patients with metastatic castration-resistant prostate cancer (mCRPC) can be offered radioligand therapy (RLT) that targets… Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer Metastatic Castration-Resistant, Prostate Cancer
- How many people
- 100 participants
- Where
- 3 sitesGermany
- Study dates
- 1 Sep 2024to Aug 2028
- How long will I take part?
- 40 Weeks
- 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: Patients with metastatic castration-resistant prostate cancer undergoing PSMA radioligand therapy
Who may be able to join
- Patients with mCRPC eligble for PSMA RLT
- In-lable use for PSMA RLT
- PSMA PET/CT not older than 8 weeks prior to first cycle of PSMA RLT
- One previous line of antiandrogen receptor pathway treatment and one previous line of taxan based therapy
- Age ≥ 18 years
- Written informed consent
- Sufficient knowledge of the German language or presence of a translator
Who cannot join
- Unwilling to adhere to study procedures
- Missing interdisciplinary tumor conference advise for PSMA RLT
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Rainer Claus, Prof. contact
Germany3 sites, 3 recruiting
- Recruiting
University hospital Wuerzburg - Department of Nuclear Medicine
Augsburg
Constantin Lapa, Prof., 0049 821 400-2050, Constantin.Lapa@uk-augsburg.de
Constantin.Lapa@uk-augsburg.de
- Recruiting
TUM Klinikum rechts der Isar - Department of Nuclear medicine
München
Matthias Eiber, Prof., +49 89 4140 2971, Matthias.Eiber@mri.tum.de
Matthias.Eiber@mri.tum.de
- Recruiting
University hospital Wuerzburg - Department of Nuclear Medicine
Würzburg
Kerstin Michalski, MD, +4993120135931, michalski_k@ukw.de
michalski_k@ukw.de
About this study
Official title: Liquid Biopsy as a Biomarker in Patients Treated With PSMA Radioligand Therapy
Prostate cancer is the second most common cause of cancer death in men worldwide. After exhausting guideline-compliant therapies or in accordance with the approval of 177Lu-PSMA-617 (Pluvicto®), patients with metastatic castration-resistant prostate cancer (mCRPC) can be offered radioligand therapy (RLT) that targets the prostate-specific membrane antigen (PSMA). Despite an initially high response rate to PSMA-RLT, the disease often progresses rapidly again. The underlying mechanisms are still poorly understood.
Liquid biopsy (LBx) involves the collection and analysis of body fluids, particularly blood. Its major advantage compared to a tissue sample is its non-invasive nature, allowing for multiple samplings, as well as the examination of more than just a single punctured lesion. Among other things, circulating tumor DNA (ctDNA) can be detected in the blood.
Read more
The aim of this study is to apply LBx before, during, and after PSMA-RLT in patients with mCRPC to determine prognostic factors before therapy and to assess the value of LBx in evaluating treatment response. Furthermore, LBx will be used to gather information on the course of potential tumor heterogeneities and to determine resistance mechanisms against PSMA-RLT.
To this end, patients receiving PSMA-RLT will be enrolled in the study at three sites (University Hospital Wuerzburg, University Hospital Augsburg, Klinikum rechts der Isar Munich). The evaluation of clinical and imaging parameters will be carried out centrally at the University Hospital Wuerzburg, while the analysis of LBx will be performed at the University Hospital Augsburg.
- Keywords
- mCRPC, PSMA, radioligand therapy, liquid biopsy, cfDNA
- Medical subject headings
- Prostatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Prognostic value of LBx (precisely ctDNA) before PSMA RLT
identification of responders (partial response and stable disease)/non-responders (progressive disease) after 2 cycles of PSMA RLT, time-to-event analysis that could provide insights into overall survival or progression-free survival based on ctDNA level
Measured: 16-18 weeks
Comparison of response assessment using LBx with biochemical response (PSA) after 2 cycles of PSMA RLT
Measured: 16-18 weeks
Comparison of response assessment using LBx with imaging-based response (PSMA PET/CT) after 2 cycles of PSMA RLT
Measured: 16-18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start1 Sep 2024
- Primary completionDec 2026 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate Cancer Metastatic Castration-ResistantStudies 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
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 40 Weeks
Sponsor and investigators
- Lead sponsor
- Wuerzburg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Augsburg, Technical University of Munich, German Research Foundation
- Responsible party
- Principal investigator, Kerstin Michalski, Wuerzburg University Hospital
- Investigators
- Kerstin Michalski, MD, Principal investigator, University hospital Wuerzburg - Department of Nuclear MedinceRainer Claus, Prof., Principal investigator, University hospital Augsburg - Internal Medicine II
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07118436
- Sponsor's protocol ID
- GZ: MI 3238/1-1
- Acronym
- LOOPS
- Status last verified
- Aug 2025
- First submitted
- 28 Jul 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Michalski K, Lorenzini T, Jedamzik T, Heinrich M, Kosmala A, Rauscher I, Bauch M, Reichl L, Amann L, Liebl S, Buck A, Eiber M, Lapa C, Claus R. Liquid Biopsy Biomarkers in Patients With Metastatic Castration-Resistant Prostate Cancer Receiving Prostate-Specific Membrane Antigen Radioligand Therapy: Protocol for a Prospective, Longitudinal Multicenter Observational Study. JMIR Res Protoc. 2026 Apr 29;15:e86737. doi: 10.2196/86737.
PubMed 42054640
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liquid Biopsy as a Biomarker in Patients Treated With PSMA Radioligand Therapy
- ClinicalTrials.gov ID
- NCT07118436
- Acronym / sponsor ID
- LOOPS / GZ: MI 3238/1-1
- Keywords
- mCRPC, PSMA, radioligand therapy, liquid biopsy, cfDNA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Wuerzburg University HospitalUniversity, hospital or other
- Collaborators
- University Hospital Augsburg, Technical University of Munich, German Research Foundation
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 12 Aug 2025 (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.
Prostate cancer is the second most common cause of cancer death in men worldwide. After exhausting guideline-compliant therapies or in accordance with the approval of 177Lu-PSMA-617 (Pluvicto®), patients with metastatic castration-resistant prostate cancer (mCRPC) can be offered radioligand therapy (RLT) that targets the prostate-specific membrane antigen (PSMA). Despite an initially high response rate to PSMA-RLT, the disease often progresses rapidly again. The underlying mechanisms are still poorly understood.
Liquid biopsy (LBx) involves the collection and analysis of body fluids, particularly blood. Its major advantage compared to a tissue sample is its non-invasive nature, allowing for multiple samplings, as well as the examination of more than just a single punctured lesion. Among other things, circulating tumor DNA (ctDNA) can be detected in the blood.
The aim of this study is to apply LBx before, during, and after PSMA-RLT in patients with mCRPC to determine prognostic factors before therapy and to assess the value of LBx in evaluating treatment response. Furthermore, LBx will be used to gather information on the course of potential tumor heterogeneities and to determine resistance mechanisms against PSMA-RLT.
To this end, patients receiving PSMA-RLT will be enrolled in the study at three sites (University Hospital Wuerzburg, University Hospital Augsburg, Klinikum rechts der Isar Munich). The evaluation of clinical and imaging parameters will be carried out centrally at the University Hospital Wuerzburg, while the analysis of LBx will be performed at the University Hospital Augsburg.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 40 Weeks
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with metastatic castration-resistant prostate cancer undergoing PSMA radioligand therapy
Key inclusion criteria (7 listed)
- Patients with mCRPC eligble for PSMA RLT
- In-lable use for PSMA RLT
- PSMA PET/CT not older than 8 weeks prior to first cycle of PSMA RLT
- One previous line of antiandrogen receptor pathway treatment and one previous line of taxan based therapy
- Age ≥ 18 years
Key exclusion criteria (2 listed)
- Unwilling to adhere to study procedures
- Missing interdisciplinary tumor conference advise for PSMA RLT
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
Prognostic value of LBx (precisely ctDNA) before PSMA RLT
Time frame: 16-18 weeks
identification of responders (partial response and stable disease)/non-responders (progressive disease) after 2 cycles of PSMA RLT, time-to-event analysis that could provide insights into overall survival or progression-free survival based on ctDNA level
Comparison of response assessment using LBx with biochemical response (PSA) after 2 cycles of PSMA RLT
Time frame: 16-18 weeks
Comparison of response assessment using LBx with imaging-based response (PSMA PET/CT) after 2 cycles of PSMA RLT
Time frame: 16-18 weeks
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 12 Aug 2025.
- Derived from this study: PubMed 42054640Michalski K, Lorenzini T, Jedamzik T, Heinrich M, Kosmala A, Rauscher I, Bauch M, Reichl L, Amann L, Liebl S, Buck A, Eiber M, Lapa C, Claus R. Liquid Biopsy Biomarkers in Patients With Metastatic Castration-Resistant Prostate Cancer Receiving Prostate-Specific Membrane Antigen Radioligand Therapy: Protocol for a Prospective, Longitudinal Multicenter Observational Study. JMIR Res Protoc. 2026 Apr 29;15:e86737. doi: 10.2196/86737.
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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.
Rainer Claus, Prof. contact
Kerstin Michalski, MD principal investigator
University hospital Wuerzburg - Department of Nuclear Medince
Rainer Claus, Prof. principal investigator
University hospital Augsburg - Internal Medicine II
3 sites 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 Castration-Resistant and Prostate Cancer, run by Wuerzburg University Hospital at 3 sites in Germany.
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 7 inclusion and 2 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 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. 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 Kerstin Michalski, MD (+4993120135931, michalski_k@ukw.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prognostic value of LBx (precisely ctDNA) before PSMA RLT (time frame: 16-18 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07118436, which also lists 1 linked publication.
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 12 Aug 2025.