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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
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
Age
18 - No limit years
Sex
MALE
Healthy Volunteers
No
Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch
Gliwice, Poland
Start Date
January 9, 2025
Primary Completion Date
November 1, 2030
Completion Date
November 1, 2030
Last Updated
February 10, 2025
200
ESTIMATED participants
Lutetium (177Lu) vipivotide tetraxetan
DRUG
Lead Sponsor
Maria Sklodowska-Curie National Research Institute of Oncology
NCT06842498
NCT05691465
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04550494