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

RecruitingPhase 2Ages 18 Years - anyMaleMaria Sklodowska-Curie National Research Institut…
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In plain words

What the trial is, and whether it could suit you

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 locoregional teleradiotherapy and hormone therapy

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • Lutetium (177Lu) vipivotide tetraxetan
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Where

1 site
Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch
Gliwice, Poland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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