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
The intervention will consist of a single administration of 177Lu-PSMA in the research arm. Both the study and control groups will receive standard hormone therapy. The study population includes 200 adult men with high-risk or very high-risk prostate cancer, with no signs of cancer dissemination in radiological examinations after completion of radiotherapy and continued hormone therapy Participation time in the Study: intervention phase - 1 day; observation phase - 5 years
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
The intervention will consist of a single administration of 7,4 GBq of lutetium (177Lu) vipivotide tetraxetan
Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch
Gliwice, Poland
RECRUITINGTreatment effectiveness
Assessment of treatment failure - the assesment of biochemical progression ratio, defined as a rise of PSA by 2 ng/mL or more above the nadir, proven by a consecutive examination performed at least 4 weeks later
Time frame: 2 and 5 years after end of treatment
Biochemical progression-free survival
Comparative assessment of biochemical progression-free survival time defined as an increase in tPSA (prostate specific antigen) in the blood above the nadir (the lowest PSA value after completion of treatment) by 2 ng/mL or more, confirmed in the next test performed no earlier than after 4 weeks
Time frame: During the intervention and follow up period (assessed up to 5 years)
Radiological progression-free survival
Comparative assessment of radiological progression-free survival defined according to PCWG3 criteria
Time frame: During the intervention and follow up period (assessed up to 5 years)
Time until the next therapeutic intervention
Comparative assessment of the time until the next therapeutic intervention
Time frame: During the intervention and follow up period (assessed up to 5 years)
Incidence of Treatment-Emergent Adverse Events according to CTCAE v 5.0
Comparative assessment of safety and tolerability of treatment according to CTCAE v 5.0
Time frame: During the intervention and follow up period (assessed up to 5 years)
Quliaty of life
Comparison of EORTC QLQ-PR25 quality of life indicators between study groups
Time frame: During the intervention and follow up period (assessed up to 5 years)
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