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177Lu-PSMA as a Systemic Adjuvant Treatment in Patients With High and Very High Risk Prostate Cancer

ConditionProstate Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorMaria Sklodowska-Curie National Research Institute of Oncology

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lutetium (177Lu) vipivotide tetraxetan

    Drug

    The intervention will consist of a single administration of 7,4 GBq of lutetium (177Lu) vipivotide tetraxetan

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: ExperimentalExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Treatment effectiveness

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

Time frame
2 and 5 years after end of treatment

Secondary outcomes

1

Biochemical progression-free survival

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

Time frame
During the intervention and follow up period (assessed up to 5 years)
2

Radiological progression-free survival

Comparative assessment of radiological progression-free survival defined according to PCWG3 criteria

Time frame
During the intervention and follow up period (assessed up to 5 years)
3

Time until the next therapeutic intervention

Comparative assessment of the time until the next therapeutic intervention

Time frame
During the intervention and follow up period (assessed up to 5 years)
4

Incidence of Treatment-Emergent Adverse Events according to CTCAE v 5.0

Comparative assessment of safety and tolerability of treatment according to CTCAE v 5.0

Time frame
During the intervention and follow up period (assessed up to 5 years)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Maria Sklodowska-Curie National Research Institute of Oncology

Lead sponsor

Source ClinicalTrials.gov
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