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

NCT06449781 | Recruiting Phase 2 DMC

• 2 other identifiers: PSMA-ADJUVONr EU CT: 2023-504912-13-00
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Prostate Cancer

Outcome Measures

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

  2 and 5 years after end of treatment

Secondary Outcomes (5)

• Biochemical progression-free survival

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

• Radiological progression-free survival

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

• 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

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

• Quliaty of life

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

Study Arms (2)

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

Control

NO INTERVENTION

Participants will receive standard hormone therapy

Interventions

Lutetium (177Lu) vipivotide tetraxetan DRUG

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

Also known as: Pluvicto

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Giving a written informed consent
• Histopathologically confirmed high or very high risk prostate cancer
• Completion of radical locoregional treatment
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch

Gliwice, 44-101, Poland

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Lutetium; Lutetium-177; Pluvicto

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Lanthanoid Series Elements; Metals, Rare Earth; Elements; Inorganic Chemicals; Transition Elements; Metals

Central Study Contacts

Daria Handkiewicz-Junak

CONTACT

48322789339; daria.handkiewicz-junak@gliwice.nio.gov.pl

Agnieszka Ciomber

CONTACT

48322789797; agnieszka.ciomber@gliwice.nio.gov.pl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open-label, two-arm, randomized study.

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: June 10, 2024
• Study Start: January 9, 2025
• Primary Completion (Estimated): November 1, 2030
• Study Completion (Estimated): November 1, 2030
• Last Updated: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)