Observational study on Lutetium-177 treatment for metastatic prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The KuPSMALu-trial is an observational study conducted at Kuopio University Hospital in Finland, focusing on patients with PSMA-positive metastatic prostate adenocarcinoma. It aims to evaluate the efficacy and safety of Lutetium-177 PSMA therapy while also researching potential biomarkers. Eligible participants must have undergone specific prior treatments and have confirmed metastatic castration-resistant prostate cancer. The study will gather data to better understand treatment outcomes and patient responses.

Why it matters

Who can join: the full rules

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.

Where it's running

• Kuopio University Hospital
  Kuopio, Northern Savonia, Finland Recruiting

Study contacts

• Study coordinator: Okko-Sakari Kääriäinen, MD
• Email: okko.kaariainen@pshyvinvointialue.fi
• Phone: +358447179433

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• PSMA-targeted therapy with hormone suppression for low-volume metastatic prostate cancer

  This phase II trial tests leuprolide acetate alone versus with 177Lu-PSMA-617 (with or without abiraterone acetate and prednisone) in men with hormone-sensitive, low-volume metastatic prostate cancer.

  Recruiting Phase 2 Mayo Clinic · Rochester, Minnesota · NCT07650240

• Testing Different Dosing Schedules of Lutetium-177Lu PSMA RLT in Advanced Prostate Cancer

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• Adding docetaxel to hormonal therapy and apalutamide for metastatic prostate cancer

  This trial tests whether giving the chemotherapy drug docetaxel in addition to hormone therapy and apalutamide helps men with metastatic castration-sensitive prostate cancer live longer.

  Recruiting at 208 sites Phase 3 Alliance for Clinical Trials in Oncology · Tucson, Arizona and 213 other locations · NCT06931340

• Combining ruxolitinib and enzalutamide for advanced prostate cancer treatment

  This study is testing if combining two medications, ruxolitinib and enzalutamide, can safely help men with advanced prostate cancer that hasn't responded to hormone therapy.

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• Evaluating a new treatment for advanced prostate cancer

  This study is testing a new radioantibody treatment for advanced prostate cancer to see how safe it is and what the best dose might be for patients with a specific type of the disease.

  Recruiting at 8 sites Phase 2 Convergent Therapeutics · San Diego, California and 8 other locations · NCT06549465

• Cell therapy combined with enzalutamide for advanced prostate cancer

  This study is testing a new combination of cell therapy and a medication called enzalutamide to see if it helps people with advanced prostate cancer live better and longer.

  Recruiting Phase 1/2 Fred Hutchinson Cancer Center · Seattle, Washington · NCT06236139

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.