177Lu-PSMA as a Systemic Adjuvant Treatment in Patients With High and Very High Risk Prostate Cancer
NCT ID: NCT06449781
Last Updated: 2025-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
200 participants
INTERVENTIONAL
2025-01-09
2030-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Long-Term Safety of Lutetium (177Lu) Vipivotide Tetraxetan in Participants With Prostate Cancer
NCT05803941
Study of Lutetium (177Lu) Vipivotide Tetraxetan in mCRPC Participants With Moderately and Severely Impaired and With Normal Renal Function
NCT06004661
In Men With Metastatic Prostate Cancer, What is the Safety and Benefit of Lutetium-177 PSMA Radionuclide Treatment in Addition to Chemotherapy
NCT04343885
Phase 2 Randomized Trial of Flexible Dosing Schedule of 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer (FLEX-MRT)
NCT06216249
177Lu-PSMA-R2 in Patients With PSMA Positive Progressive, Metastatic, Castration Resistant Prostate Cancer
NCT03490838
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Experimental
The intervention will consist of a single administration of 177Lu-PSMA with an activity of 7.4 GBq. Participants will also receive standard hormone therapy
Lutetium (177Lu) vipivotide tetraxetan
The intervention will consist of a single administration of 7,4 GBq of lutetium (177Lu) vipivotide tetraxetan
Control
Participants will receive standard hormone therapy
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Lutetium (177Lu) vipivotide tetraxetan
The intervention will consist of a single administration of 7,4 GBq of lutetium (177Lu) vipivotide tetraxetan
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* Absence of approval to use effective contraception method
* Absence of Patient's consent to participate in the Study
* Urinary tract obstruction or/and hydronephrosis.
* Concurrent anticancer treatment.
18 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Maria Sklodowska-Curie National Research Institute of Oncology
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch
Gliwice, , Poland
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Nr EU CT: 2023-504912-13-00
Identifier Type: OTHER
Identifier Source: secondary_id
PSMA-ADJUVO
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.