Status:

RECRUITING

177Lu-PSMA as a Systemic Adjuvant Treatment in Patients With High and Very High Risk Prostate Cancer

Lead Sponsor:

Maria Sklodowska-Curie National Research Institute of Oncology

Conditions:

Prostate Cancer

Eligibility:

MALE

18+ years

Phase:

PHASE2

Brief Summary

Single-center, non-commercial phase 2 clinical trial to evaluate 177Lu-PSMA as a systemic adjuvant treatment in patients with high and very high risk prostate cancer after radical treatment using loco...

Detailed Description

The intervention will consist of a single administration of 177Lu-PSMA in the research arm. Both the study and control groups will receive standard hormone therapy. The study population includes 200 ...

Eligibility Criteria

Inclusion Criteria:

  • Giving a written informed consent

  • Histopathologically confirmed high or very high risk prostate cancer

  • Completion of radical locoregional treatment

  • Completion of locoregional treatment within 3 months before inclusion to the study

  • ECOG performance status 0 to 2

  • Age over 18 years

  • Within 28 days before entering the study, there were no signs of cancer dissemination documented in radiological tests

  • Castrate testosterone level (testosteron < 50 ng/dL lub 1,7 nmol/L)

  • Patients with adequate function of main organs:

    • bone marrow:

      • neutrophils > 1500x10^9/L;
      • thrombocytes > 100,000x10^9/L;
      • hemoglobin > 9 g/dL
    • liver:

      • bilirubin < 2xULN (upper limit of normal) in patients with Gilbert's syndrome < 5xULN;
      • aminotransferase < 3xULN
    • kidneys:

      • eGFR > 50 ml/min
      • albumin >2.5 mg/ml
  • For men of reproductive age: the need to use double barrier contraception

Exclusion Criteria:

  • The presence of distant metastases confirmed by radiological examination
  • Absence of approval to use effective contraception method
  • Absence of Patient's consent to participate in the Study
  • Urinary tract obstruction or/and hydronephrosis.
  • Concurrent anticancer treatment.

Key Trial Info

Start Date :

January 9 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

November 1 2030

Estimated Enrollment :

200 Patients enrolled

Trial Details

Trial ID

NCT06449781

Start Date

January 9 2025

End Date

November 1 2030

Last Update

February 10 2025

Active Locations (1)

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Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch

Gliwice, Poland, 44-101

177Lu-PSMA as a Systemic Adjuvant Treatment in Patients With High and Very High Risk Prostate Cancer | DecenTrialz