Actively Recruiting
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
Led by Maria Sklodowska-Curie National Research Institute of Oncology · Updated on 2025-02-10
200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of lutetium (177Lu) vipivotide tetraxetan, administered as a single dose, as a systemic adjuvant treatment for adult men with high or very high risk prostate cancer. This phase 2 clinical trial focuses on patients who have completed radical locoregional teleradiotherapy and hormone therapy and show no signs of cancer spread in recent radiological exams. The study aims to assess treatment effectiveness and progression-free survival over a long follow-up period. Participants are randomly assigned to one of two groups: one receiving a single administration of 7.4 GBq of 177Lu-PSMA alongside standard hormone therapy, and the other receiving hormone therapy alone. The intervention phase lasts one day, after which participants enter a five-year observation phase to monitor outcomes and safety. Both groups continue with standard hormone therapy throughout the study. During the study, researchers will conduct regular assessments including biochemical and radiological evaluations to track cancer progression, quality of life measures, and adverse events. The primary outcome is treatment effectiveness measured at two and five years after treatment. Participants will be monitored for up to five years to observe progression-free survival, time to next therapy, and overall health status. The study is sponsored by the Maria Sklodowska-Curie National Research Institute of Oncology.
CONDITIONS
Brief 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
- No signs of cancer dissemination documented in radiological tests within 28 days before entering the study
- 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
- Absence of approval to use effective contraception method
- Absence of patient's consent to participate in the study
- Urinary tract obstruction and/or hydronephrosis
- Concurrent anticancer treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive a single administration of 177Lu-PSMA along with standard hormone therapy or standard hormone therapy alone.
1 treatment visit (in-person)
Duration - 5 years
Participants are observed for up to 5 years to monitor treatment effectiveness and safety.
Regular follow-up visits during 5 years
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
A
Agnieszka Ciomber
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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