NCT06850545Recruiting
Kuopio Lutetium-177 Study in Patients with PSMA-Positive Metastatic Prostate Cancer
Source: ClinicalTrials.gov · Last updated 27 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 150 (estimated)
- First submitted
- 22 Feb 2025
- Start date
- 10 Jan 2020
- Primary completion date
- 31 Dec 2030
- Lead sponsor
- Kuopio University Hospital
- Diseases
- Prostate cancer
- NCT number
- NCT06850545
What you commit to
- Study type: Observational
- Planned participants: 150
- From 10 Jan 2020 to the primary completion date, 31 Dec 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients whose physical condition and cooperation are insufficient to follow the given instructions.
- Patients must not have a recurrent infection that impairs functional capacity.
Other
- 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.
Who the study is looking for
- 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).
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kuopio University Hospital Coordinator of this site? Confirm its status | Kuopio | Finland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.