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

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

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

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: Lutetium (177Lu) vipivotide tetraxetan

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 Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Agnieszka Ciomber; Phone Number: 48322789797; Email: agnieszka.ciomber@gliwice.nio.gov.pl
• Study Contact Backup: Name: Daria Handkiewicz-Junak; Phone Number: 48322789339; Email: daria.handkiewicz-junak@gliwice.nio.gov.pl

Study Locations

• Poland
  • Gliwice, Poland, 44-101
    • Recruiting
    • Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch
    • Contact: Tomasz Lachcik; Phone Number: +48322789791; Email: tomasz.lachcik@gliwice.nio.gov.pl
    • Contact: Daria Handkiewicz-Junak, Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; 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	Drug: Lutetium (177Lu) vipivotide tetraxetan; The intervention will consist of a single administration of 7,4 GBq of lutetium (177Lu) vipivotide tetraxetan; Other Names: Pluvicto
No Intervention: Control; Participants will receive standard hormone therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2 and 5 years after end of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	During the intervention and follow up period (assessed up to 5 years)
Radiological progression-free survival	Comparative assessment of radiological progression-free survival defined according to PCWG3 criteria	During the intervention and follow up period (assessed up to 5 years)
Time until the next therapeutic intervention	Comparative assessment of the time until the next therapeutic intervention	During the intervention and follow up period (assessed up to 5 years)
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	During the intervention and follow up period (assessed up to 5 years)
Quliaty of life	Comparison of EORTC QLQ-PR25 quality of life indicators between study groups	During the intervention and follow up period (assessed up to 5 years)

Collaborators and Investigators

• Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2025
• Primary Completion (Estimated): November 1, 2030
• Study Completion (Estimated): November 1, 2030

Study Registration Dates

• First Submitted: December 6, 2023
• First Submitted That Met QC Criteria: June 7, 2024
• First Posted (Actual): June 10, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 5, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Molecular Mechanisms of Pharmacological Action; Chelating Agents; Sequestering Agents; 1,4,7,10-tetraazacyclododecane- 1,4,7,10-tetraacetic acid
• Other Study ID Numbers: PSMA-ADJUVO; Nr EU CT: 2023-504912-13-00 (Other Identifier: EMA)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No