Using 177Lu-PSMA to treat high-risk prostate cancer after radical treatment

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

This phase 2 clinical trial evaluates the effectiveness of 177Lu-PSMA as a systemic adjuvant treatment for adult men with high and very high-risk prostate cancer following radical locoregional treatment and hormone therapy. Participants will receive a single administration of 177Lu-PSMA, while both the study and control groups will continue standard hormone therapy. The study aims to assess the safety and efficacy of this intervention over a five-year observation period, focusing on patients who show no signs of cancer dissemination after their initial treatment.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Study coordinator: Daria Handkiewicz-Junak
• Email: daria.handkiewicz-junak@gliwice.nio.gov.pl
• Phone: 48322789339

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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.