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RECRUITINGPhase 2INTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: - Giving a written willing to sign a consent form - 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 - You should be able to carry out daily activities with 0 level of ability (ECOG 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 Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Lutetium (177Lu) vipivotide tetraxetan

The intervention will consist of a single administration of 7,4 GBq of lutetium (177Lu) vipivotide tetraxetan

Locations (1)

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