Actively Recruiting
177Lu-PSMA as a Systemic Adjuvant Treatment in Patients With High and Very High Risk Prostate Cancer
Led by Maria Sklodowska-Curie National Research Institute of Oncology · Updated on 2025-02-10
200
Participants Needed
1
Research Sites
303 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
177Lu-PSMA as a Systemic Adjuvant Treatment in Patients With High and Very High Risk Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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, no signs of cancer dissemination in radiological tests
- Castrate testosterone level (testosterone < 50 ng/dL or 1.7 nmol/L)
- Adequate bone marrow function: neutrophils > 1500x10^9/L; thrombocytes > 100,000x10^9/L; hemoglobin > 9 g/dL
- Adequate liver function: bilirubin < 2xULN (or < 5xULN for Gilbert's syndrome); aminotransferase < 3xULN
- Adequate kidney function: eGFR > 50 ml/min; albumin > 2.5 mg/ml
- For men of reproductive age: use of double barrier contraception
You will not qualify if you...
- Presence of distant metastases confirmed by radiological examination
- Lack of approval to use an effective contraception method
- Lack of patient consent to participate in the study
- Urinary tract obstruction and/or hydronephrosis
- Concurrent anticancer treatment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch
Gliwice, Poland, 44-101
Actively Recruiting
Research Team
D
Daria Handkiewicz-Junak
CONTACT
A
Agnieszka Ciomber
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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