Actively Recruiting

Age: 18Years +
MALE
NCT06850545

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

Led by Kuopio University Hospital · Updated on 2025-02-27

150

Participants Needed

1

Research Sites

833 weeks

Total Duration

On this page

Sponsors

K

Kuopio University Hospital

Lead Sponsor

U

University of Eastern Finland

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 treated with at least docetaxel and abiraterone or enzalutamide, or 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 chemically (LHRH analog or antagonist) or surgically (orchiectomy), defined as low testosterone level (S-testosterone 64 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, ALT and ALP < 5x upper limit of normal).
  • Patients' blood counts must be within acceptable levels (Hb 65 100 g/l, Platelets 65 100 x 109/L, Leukocytes 65 3.0 x 109/L, or Neutrophils 65 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 treatments and for 6 months after treatment completion.
Not Eligible

You will not qualify if you...

  • Patients whose physical condition and cooperation are insufficient to follow instructions.
  • Patients who do not meet the inclusion criteria.
  • Patients must not have PSMA-negative tumor burden in the liver exceeding 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.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Kuopio University Hospital

Kuopio, Northern Savonia, Finland, 70210

Actively Recruiting

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Research Team

O

Okko-Sakari Kääriäinen, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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