177Lu-PSMA as a Systemic Adjuvant Treatment in Patients With High and Very High Risk Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lutetium (177Lu) vipivotide tetraxetan.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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 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
Interventions
- Drug Lutetium (177Lu) vipivotide tetraxetan
The intervention will consist of a single administration of 7,4 GBq of lutetium (177Lu) vipivotide tetraxetan
Primary outcome measures
- Treatment effectiveness [Time frame: 2 and 5 years after end of treatment]
Secondary outcome measures (5)
- Biochemical progression-free survival [Time frame: During the intervention and follow up period (assessed up to 5 years)]
- Radiological progression-free survival [Time frame: During the intervention and follow up period (assessed up to 5 years)]
- 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 [Time frame: During the intervention and follow up period (assessed up to 5 years)]
- Quliaty of life [Time frame: During the intervention and follow up period (assessed up to 5 years)]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Poland · 1 center
- Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch — Gliwice
Identifiers
NCT: NCT06449781 · PSMA-ADJUVO · Nr EU CT: 2023-504912-13-00