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Trial Title:
177Lu-PSMA as a Systemic Adjuvant Treatment in Patients With High and Very High Risk Prostate Cancer
NCT ID:
NCT06449781
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
1,4,7,10-tetraazacyclododecane- 1,4,7,10-tetraacetic acid
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Open-label, two-arm, randomized study.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Lutetium (177Lu) vipivotide tetraxetan
Description:
The intervention will consist of a single administration of 7,4 GBq of lutetium (177Lu)
vipivotide tetraxetan
Arm group label:
Experimental
Other name:
Pluvicto
Summary:
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
Detailed description:
The intervention will consist of a single administration of 177Lu-PSMA with an activity
of 7.4 GBq 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
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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, 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:
- The 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 or/and hydronephrosis.
- Concurrent anticancer treatment.
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
June 2024
Completion date:
November 2030
Lead sponsor:
Agency:
Maria Sklodowska-Curie National Research Institute of Oncology
Agency class:
Other
Source:
Maria Sklodowska-Curie National Research Institute of Oncology
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06449781
