Kuopio Lutetium-177 Study in Patients with PSMA-Positive... | NCT06850545

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

NCT06850545

Sponsor

Kuopio University Hospital

Status

Recruiting

Last Update Posted

Feb 27, 2025Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

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

Interventions

Not provided

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 10, 2020Actual

Primary Completion Date

Dec 31, 2030Estimated

Completion Date

Dec 31, 2035Estimated

First Submitted Date

Feb 22, 2025

First Submission Date that Met QC Criteria

Feb 22, 2025

First Posted Date

Feb 27, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 22, 2025

Last Update Posted Date

Feb 27, 2025Actual

Name	Class
University of Eastern Finland	OTHER

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

Patients whose physical condition and cooperation are insufficient to follow the given instructions.
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.
Patients must not have a recurrent infection that impairs functional capacity.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample