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

NCT06850545 | Recruiting

• 1 other identifier: KUH5654217
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Overall survival in the trial

  5 years

Secondary Outcomes (2)

• PSA decrease of 50% or more

  36 weeks

• Adverse Events

  36 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Patients whose physical condition and cooperation are insufficient to follow the given instructions.
• 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.

Sponsors & Collaborators

• Kuopio University Hospital: lead
• University of Eastern Finland: collaborator

Study Sites (1)

Kuopio University Hospital

Kuopio, Northern Savonia, 70210, Finland

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

cfDNA samples during the treatment

Central Study Contacts

Okko-Sakari Kääriäinen, MD

CONTACT

+358447179433; okko.kaariainen@pshyvinvointialue.fi

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical oncologist

Study Record Dates

• First Submitted: February 22, 2025
• First Posted: February 27, 2025
• Study Start: January 10, 2020
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2035
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)