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

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 locoregional teleradiotherapy and hormone therapy

Eligibility

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.

Conditions2

Browse More Trials