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

Phase 2

Recruiting

• Conditions: Prostate Cancer
• Interventions: Drug: Lutetium (177Lu) vipivotide tetraxetan

• Registration Number: NCT06449781
• Lead Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology

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

Study Timeline

• Study First Submitted: 2023-12-06
• Study First Submitted QC: 2024-06-07
• Study First Posted: 2024-06-10
• Study Start: 2025-01-09
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-05
• Last Update Posted: 2025-02-10
• Primary Completion: 2030-11
• Study Completion: 2030-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Lutetium (177Lu) vipivotide tetraxetan	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch; 🇵🇱 Gliwice, Poland