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

Maria Sklodowska-Curie National Research Institute of Oncology

Status and phase: Enrolling; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: Lutetium (177Lu) vipivotide tetraxetan

Study type: Interventional

Funder types: Other

Identifiers

NCT06449781

PSMA-ADJUVO

Nr EU CT: 2023-504912-13-00 (Other Identifier)

Details and patient eligibility

About

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

Full 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

Enrollment: 200 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Experimental

Experimental group

Description:

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

Treatment:

Drug: Lutetium (177Lu) vipivotide tetraxetan

Control

No Intervention group

Description:

Participants will receive standard hormone therapy