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

Launched by MARIA SKLODOWSKA-CURIE NATIONAL RESEARCH INSTITUTE OF ONCOLOGY · Jun 7, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment option called 177Lu-PSMA for men with high-risk prostate cancer who have already undergone major treatments like surgery or radiation. The goal is to see if this treatment can help prevent the cancer from coming back after these initial therapies. The trial is currently recruiting participants, specifically men aged 18 and older who have been diagnosed with high or very high-risk prostate cancer and have recently completed their primary treatment.

To join the study, participants need to meet certain criteria, such as showing no signs of cancer spread in recent tests and having specific levels of testosterone and organ function. Those who take part can expect to receive regular evaluations and monitoring throughout the trial to ensure their safety and health. It's important to note that men who are able to father children will need to use effective birth control during the study. This trial is a step towards finding better ways to manage prostate cancer and improve outcomes for patients at high risk.

Gender

MALE

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.