Metastatic Prostate Adenocarcinoma, PSMA PET-Positive Castration-Resistant Prostate Cancer
Conditions
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.
Interventions
None listed
Sponsors
University of Eastern Finland
Kuopio University Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 5 years | Overall survival in the trial |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PSA decrease of 50% or more | 36 weeks | PSA decrease of 50% or more within the treatment period |
| Adverse Events | 36 weeks | Treatment-related grade ≥3 and serious adverse events |
Countries
Finland
Contacts
Primary ContactOkko-Sakari Kääriäinen, MD
Outcome results
None listed