A Dosimetry Study of Lutetium (177Lu) rhPSMA-10.1 and Lutetium (177Lu) Vipivotide Tetraxetan (Pluvicto®) in Patients With Non-curative Metastatic Prostate Cancer

NCT ID: NCT06516510

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-31
• Study Completion Date: 2025-08-15

Brief Summary

A randomised, multi-centre, intra-patient imaging and dosimetry crossover study of lutetium (177Lu) rhPSMA 10.1 and lutetium (177Lu) vipivotide tetraxetan (Pluvicto®) in patients with non-curative metastatic prostate cancer

Conditions

Metastatic Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Sequence A

Patients in Sequence A will receive lutetium (177Lu) rhPSMA 10.1 followed by lutetium (177Lu) vipivotide tetraxetan

Group Type: OTHER

lutetium (177Lu) rhPSMA 10.1 and Pluvicto®

Intervention Type: DRUG

Radiopharmaceutical

Sequence B

Patients in Sequence B will receive lutetium (177Lu) vipivotide tetraxetan followed by lutetium (177Lu) rhPSMA 10.1

Group Type: OTHER

lutetium (177Lu) rhPSMA 10.1 and Pluvicto®

Intervention Type: DRUG

Radiopharmaceutical

Interventions

lutetium (177Lu) rhPSMA 10.1 and Pluvicto®

Radiopharmaceutical

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male patient aged ≥60 years old at Visit 1 (Screening).
• Patient has non-curative PSMA-positive prostate cancer that has spread outside of the prostate gland and is undergoing or being planned for radioligand therapy.
• At least 1 PSMA-positive lesion that can be outlined on PET or CT and ≥1 cm in the short axis measured on either modality, for the purpose of dosimetry.
• Adequate normal organ function as demonstrated by:

• Absolute neutrophil count ≥1.5 × 109/L
• Platelets ≥100 × 109/L
• Haemoglobin ≥9 g/dL
• Total bilirubin <2 × the institutional upper limit of normal (ULN). For patients with known Gilbert's Syndrome, ≤3 × ULN is permitted.
• Alanine aminotransferase (ALT) or aspartate transaminase (AST) ≤3.0 × ULN or ≤5.0 × ULN for patients with liver metastases.
• Estimated glomerular filtration rate (using Chronic Kidney Disease Epidemiology Collaboration Creatinine Equation [2009]) >50 mL/min.
• Willing to provide signed and dated written informed consent form (ICF) prior to any study specific procedures
• Male patients must agree not to father children or donate sperm during the study and for at least 14 weeks after the last study treatment.

Exclusion Criteria

• Known hypersensitivity to lutetium (177Lu) rhPSMA 10.1 or lutetium (177Lu) vipivotide tetraxetan, or any of the constituents.
• Previous treatment with any radiopharmaceutical therapy in the 42 days or 5 half-lives prior to Visit 1 (Screening).
• Any significant metallic implants or objects, which may in the opinion of the investigator, affect image quality and/or dosimetry calculations.
• Severe claustrophobia, inability to lie flat or fit into the scanner, or any other inability to tolerate the SPECT/CT scan protocol
• Any change to prostate cancer medication or new prostate cancer therapy, prostate cancer surgical procedure within 42 days prior to screening or during the study.
• Any medical or psychiatric condition, including rapidly progressive prostate cancer, that in the investigator's judgment, makes the patient unsuitable for the study
• Participation in other studies involving other IMPs within 42 days or 5 half lives (whichever is longer) prior to Visit 1 (Screening) and/or during study participation

• Minimum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Medpace, Inc.

INDUSTRY

Sponsor Role: collaborator

Blue Earth Therapeutics Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Blue Earth Therapeutics

Role: STUDY_DIRECTOR

Blue Earth Therapeutics

Locations

Biogenix Molecular LLC

Miami, Florida, United States

Emory University Hospital

Atlanta, Georgia, United States

Radboud UMC

Nijmegen, Gelderland, Netherlands

Centro Integral Oncologico Clara Campal

Madrid, Madrid, Spain

Clinica Universidad de Navarra - Pamplona

Pamplona, Navarre, Spain

Clinica Universidad de Navarra

Madrid, , Spain

Countries

United States; Netherlands; Spain

Other Identifiers

BET-PSMA-001

Identifier Type: -

Identifier Source: org_study_id