Prostate Cancer
Conditions
Brief 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 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
The intervention will consist of a single administration of 7,4 GBq of lutetium (177Lu) vipivotide tetraxetan
Sponsors
Maria Sklodowska-Curie National Research Institute of Oncology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open-label, two-arm, randomized study.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment effectiveness | 2 and 5 years after end of treatment | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biochemical progression-free survival | During the intervention and follow up period (assessed up to 5 years) | 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 |
| Radiological progression-free survival | During the intervention and follow up period (assessed up to 5 years) | Comparative assessment of radiological progression-free survival defined according to PCWG3 criteria |
| Time until the next therapeutic intervention | During the intervention and follow up period (assessed up to 5 years) | Comparative assessment of the time until the next therapeutic intervention |
| Incidence of Treatment-Emergent Adverse Events according to CTCAE v 5.0 | During the intervention and follow up period (assessed up to 5 years) | Comparative assessment of safety and tolerability of treatment according to CTCAE v 5.0 |
| Quliaty of life | During the intervention and follow up period (assessed up to 5 years) | Comparison of EORTC QLQ-PR25 quality of life indicators between study groups |
Countries
Poland
Contacts
Primary ContactDaria Handkiewicz-Junak
Backup ContactAgnieszka Ciomber
Outcome results
None listed