Observational study on Lutetium-177 treatment for metastatic prostate cancer

Kuopio Lutetium-177 Study in Patients with PSMA-Positive Metastatic Prostate Cancer

This study is testing if Lutetium-177 treatment can help men with advanced prostate cancer feel better and understand how their bodies respond to the therapy.

Quick facts

• Study type: Observational
• Enrollment: 150 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: Kuopio University Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Kuopio, Northern Savonia)
• Trial ID: NCT06850545 on ClinicalTrials.gov

What this trial studies

The KuPSMALu-trial is an observational study conducted at Kuopio University Hospital in Finland, focusing on patients with PSMA-positive metastatic prostate adenocarcinoma. It aims to evaluate the efficacy and safety of Lutetium-177 PSMA therapy while also researching potential biomarkers. Eligible participants must have undergone specific prior treatments and have confirmed metastatic castration-resistant prostate cancer. The study will gather data to better understand treatment outcomes and patient responses.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 with histologically confirmed metastatic prostate adenocarcinoma who have undergone specific prior treatments.

Not a fit: Patients who have not been treated with docetaxel or abiraterone/enzalutamide, or those with non-adenocarcinoma prostate cancer, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the effectiveness of Lutetium-177 therapy for patients with advanced prostate cancer.

How similar studies have performed: While this approach is being explored, similar studies have shown promise in using targeted radioligand therapy for prostate cancer.

Eligibility criteria

Inclusion Criteria:

1. The patient must sign informed consent to participate in the study.
2. Patients must be over 18 years of age.
3. Patients must have histologically confirmed metastatic prostate adenocarcinoma. Histological samples may show neuroendocrine features, but the primary component must be adenocarcinoma.
4. 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.
5. Patients must have an adequate performance status: WHO 0-2.
6. 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).
7. Patients must have PSMA-positive tumor burden detected by 18F-PSMA-PET-CT imaging.
8. Patients must have adequate renal and liver function (Creatinine \< 2x upper limit of normal (ULN), ALT and ALP \< 5x ULN).
9. 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).
10. The expected survival must be more than 6 months.
11. Patients with ejaculatory capacity must commit to not donating sperm during the treatments and for 6 months after treatment completion.

Exclusion Criteria:

1. Patients whose physical condition and cooperation are insufficient to follow the given instructions.
2. Patients who do not meet the criteria mentioned in the inclusion criteria.
3. 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.
4. Patients with symptomatic untreated spinal cord compression.
5. Patients must not have acute hydronephrosis or urinary tract obstruction.
6. Patients must not have a recurrent infection that impairs functional capacity.

Where this trial is running

Kuopio, Northern Savonia

• Kuopio University Hospital — Kuopio, Northern Savonia, Finland (Recruiting)

Study contacts

• Study coordinator: Okko-Sakari Kääriäinen, MD

Conditions Metastatic Prostate Adenocarcinoma; PSMA PET-Positive Castration-Resistant Prostate Cancer