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

Prostate Cancer Clinical Trial

— PSMA-ADJUVO  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06449781
• Other study ID #: PSMA-ADJUVO
• Secondary ID: Nr EU CT: 2023-5
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 2024
• Est. completion date: November 2030

Study information

• Verified date: November 2023
• Source: Maria Sklodowska-Curie National Research Institute of Oncology
• Contact: Daria Handkiewicz-Junak
• Phone: 48322789339
• Email: daria.handkiewicz-junak[@]gliwice.nio.gov.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

The intervention will consist of a single administration of 177Lu-PSMA with an activity of 7.4 GBq 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: November 2030
• Est. primary completion date: November 2030
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Maria Sklodowska-Curie National Research Institute of Oncology

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)