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

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 Overview

• Status: Recruiting
• Conditions: Metastatic Prostate Adenocarcinoma; PSMA PET-Positive Castration-Resistant Prostate Cancer

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Okko-Sakari Kääriäinen, MD; Phone Number: +358447179433; Email: okko.kaariainen@pshyvinvointialue.fi

Study Locations

• Finland
  • North Savo
    • Kuopio, North Savo, Finland, 70210
      • Recruiting
      • Kuopio University Hospital
      • Contact: Okko-Sakari Kääriäinen, MD; Phone Number: +358447179433; Email: okko.kaariainen@pshyvinvointialue.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

mCPRC patients treated with 177LuPSMA-I&T in Kuopio University Hospital.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Overall survival in the trial	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PSA decrease of 50% or more	PSA decrease of 50% or more within the treatment period	36 weeks
Adverse Events	Treatment-related grade ≥3 and serious adverse events	36 weeks

Collaborators and Investigators

• Sponsor: Kuopio University Hospital
• Collaborators: University of Eastern Finland

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2020
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2035

Study Registration Dates

• First Submitted: February 22, 2025
• First Submitted That Met QC Criteria: February 22, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 22, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: KUH5654217

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No