NCT06449781RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 16 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 6 Dec 2023
- Start date
- 9 Jan 2025
- Primary completion date
- Nov 2030
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of Oncology
- Diseases
- Prostate cancer
- NCT number
- NCT06449781
- EU CT number
- 2023-504912-13-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 200
- From 9 Jan 2025 to the primary completion date, Nov 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent anticancer treatment.
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Gliwice | Poland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.