Metastatic Prostate AdenocarcinomaKuPSMALuNCT06850545
Kuopio Lutetium-177 Study in Patients with PSMA-Positive Metastatic Prostate Cancer
An observational study of Metastatic Prostate Adenocarcinoma and PSMA PET-Positive Castration-Resistant Prostate Cancer, run by Kuopio University Hospital at 1 site in Finland.
Trial summary
KuPSMALu-trial is an observational study for patients treated with 177LuPSMA-I\&T in Kuopio University Hospital, Finland. Study focuses on efficacy, safety and biomarker research. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Prostate Adenocarcinoma, PSMA PET-Positive Castration-Resistant Prostate Cancer
- How many people
- 150 participants
- Where
- 1 siteFinland
- Study dates
- 10 Jan 2020to 31 Dec 2035
- How long will I take part?
- 5 Years
- 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: mCPRC patients treated with 177LuPSMA-I\&T in Kuopio University Hospital.
Who may be able to join
- The patient must sign informed consent to participate in the study.
- Patients must be over 18 years of age.
- Patients must have histologically confirmed metastatic prostate adenocarcinoma. Histological samples may show neuroendocrine features, but the primary component must be adenocarcinoma.
- Patients must have metastatic castration-resistant prostate cancer (mCRPC) that has been treated with at least docetaxel and abiraterone or enzalutamide, or the patients must have declined chemotherapy or be ineligible for docetaxel-based chemotherapy due to contraindications.
- Patients must have an adequate performance status: WHO 0-2.
- Castration must have been achieved either chemically (LHRH analog or antagonist) or surgically (orchiectomy). Castration is defined as a low testosterone level (S-testosterone ≤ 1.7 mmol/l).
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- Patients must have PSMA-positive tumor burden detected by 18F-PSMA-PET-CT imaging.
- Patients must have adequate renal and liver function (Creatinine < 2x upper limit of normal (ULN), ALT and ALP < 5x ULN).
- Patients' blood counts must be within acceptable levels (Hb ≥ 100 g/l, Platelets ≥ 100 x 10⁹/L, Leukocytes ≥ 3.0 x 10⁹/L, or Neutrophils ≥ 1.0 x 10⁹/L).
- The expected survival must be more than 6 months.
- Patients with ejaculatory capacity must commit to not donating sperm during the treatments and for 6 months after treatment completion.
Who cannot join
- Patients whose physical condition and cooperation are insufficient to follow the given instructions.
- Patients who do not meet the criteria mentioned in the inclusion criteria.
- Patients must not have PSMA-negative tumor burden in the liver. The amount of PSMA-negative tumor burden must not exceed the amount of PSMA-positive tumor burden.
- Patients with symptomatic untreated spinal cord compression.
- Patients must not have acute hydronephrosis or urinary tract obstruction.
- Patients must not have a recurrent infection that impairs functional capacity.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
Kuopio University Hospital
Kuopio, Northern Savonia, 70210
Okko-Sakari Kääriäinen, MD, +358447179433, okko.kaariainen@pshyvinvointialue.fi
About this study
KuPSMALu-trial is an observational study for patients treated with 177LuPSMA-I\&T in Kuopio University Hospital, Finland. Study focuses on efficacy, safety and biomarker research.
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Overall survival in the trial
Measured: 5 years
Secondary outcomes (2)
PSA decrease of 50% or more
PSA decrease of 50% or more within the treatment period
Measured: 36 weeks
Adverse Events
Treatment-related grade ≥3 and serious adverse events
Measured: 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start10 Jan 2020
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Prostate AdenocarcinomaStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Eastern Finland
- Responsible party
- Principal investigator, Okko Kääriäinen, Kuopio University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06850545
- Sponsor's protocol ID
- KUH5654217
- Acronym
- KuPSMALu
- Status last verified
- Feb 2025
- First submitted
- 22 Feb 2025
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kuopio Lutetium-177 Study in Patients with PSMA-Positive Metastatic Prostate Cancer
- ClinicalTrials.gov ID
- NCT06850545
- Acronym / sponsor ID
- KuPSMALu / KUH5654217
- Conditions
- Metastatic Prostate Adenocarcinoma, PSMA PET-Positive Castration-Resistant Prostate Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Collaborators
- University of Eastern Finland
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 27 Feb 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.
KuPSMALu-trial is an observational study for patients treated with 177LuPSMA-I\&T in Kuopio University Hospital, Finland. Study focuses on efficacy, safety and biomarker research.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- mCPRC patients treated with 177LuPSMA-I\&T in Kuopio University Hospital.
Key inclusion criteria (11 listed)
- The patient must sign informed consent to participate in the study.
- Patients must be over 18 years of age.
- Patients must have histologically confirmed metastatic prostate adenocarcinoma. Histological samples may show neuroendocrine features, but the primary component must be adenocarcinoma.
- Patients must have metastatic castration-resistant prostate cancer (mCRPC) that has been treated with at least docetaxel and abiraterone or enzalutamide, or the patients must have declined chemotherapy or be ineligible for docetaxel-based chemotherapy due to contraindications.
- Patients must have an adequate performance status: WHO 0-2.
Key exclusion criteria (6 listed)
- Patients whose physical condition and cooperation are insufficient to follow the given instructions.
- Patients who do not meet the criteria mentioned in the inclusion criteria.
- Patients must not have PSMA-negative tumor burden in the liver. The amount of PSMA-negative tumor burden must not exceed the amount of PSMA-positive tumor burden.
- Patients with symptomatic untreated spinal cord compression.
- Patients must not have acute hydronephrosis or urinary tract obstruction.
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
Overall survival
Time frame: 5 years
Overall survival in the trial
2 secondary outcomes
PSA decrease of 50% or more
Time frame: 36 weeks
Adverse Events
Time frame: 36 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 27 Feb 2025.
- Individual participant dataSharing planned: No
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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 Metastatic Prostate Adenocarcinoma and PSMA PET-Positive Castration-Resistant Prostate Cancer, run by Kuopio University Hospital at 1 site in Finland.
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 11 inclusion and 6 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 Feb 2025. 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 Finland. 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 Okko-Sakari Kääriäinen, MD (+358447179433, okko.kaariainen@pshyvinvointialue.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 5 years). 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 Feb 2025.