NCT06449781 177Lu-PSMA as a Systemic Adjuvant Treatment in Patients With High and Very High Risk Prostate Cancer
| NCT ID | NCT06449781 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Maria Sklodowska-Curie National Research Institute of Oncology |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-01-09 |
| Primary Completion | 2030-11 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 200 participants in total. It began in 2025-01-09 with a primary completion date of 2030-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06449781 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06449781 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06449781 currently recruiting?
Yes, NCT06449781 is actively recruiting participants. Contact the research team at daria.handkiewicz-junak@gliwice.nio.gov.pl for enrollment information.
Where is the NCT06449781 trial being conducted?
This trial is being conducted at Gliwice, Poland.
Who is sponsoring the NCT06449781 clinical trial?
NCT06449781 is sponsored by Maria Sklodowska-Curie National Research Institute of Oncology. The trial plans to enroll 200 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.