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

Early Phase 1

Recruiting

• Conditions: Metastatic Prostate Cancer
• Interventions: Drug: lutetium (177Lu) rhPSMA 10.1 and Pluvicto®

• Registration Number: NCT06516510
• Lead Sponsor: Blue Earth Therapeutics Ltd

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-17
• Study First Submitted QC: 2024-07-17
• Study First Posted: 2024-07-24
• Study Start: 2024-10-31
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-07
• Primary Completion: 2025-10
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence A	lutetium (177Lu) rhPSMA 10.1 and Pluvicto®	Patients in Sequence A will receive lutetium (177Lu) rhPSMA 10.1 followed by lutetium (177Lu) vipivotide tetraxetan
Sequence B	lutetium (177Lu) rhPSMA 10.1 and Pluvicto®	Patients in Sequence B will receive lutetium (177Lu) vipivotide tetraxetan followed by lutetium (177Lu) rhPSMA 10.1

Primary Outcome Measures

Name	Time	Method
To compare the ratio of the kidney and the tumour absorbed doses of lutetium (177Lu) rhPSMA 10.1 and lutetium (177Lu) vipivotide tetraxetan.	4-12 weeks

Secondary Outcome Measures

Name	Time	Method
To compare the absorbed dose of lutetium (177Lu) rhPSMA 10.1 and lutetium (177Lu) vipivotide tetraxetan to tumour lesions and additional organs of interest.	4-12 weeks
To further evaluate the safety profile through frequency of treatment related adverse events of lutetium (177Lu) rhPSMA 10.1 injection	4-12 weeks
To compare the tumour and normal organ effective half lives of lutetium (177Lu) rhPSMA 10.1 and lutetium (177Lu) vipivotide tetraxetan.	4-12 weeks

Trial Locations

Locations (5)

Radboud UMC; 🇳🇱 Nijmegen, Gelderland, Netherlands

Biogenix Molecular; 🇺🇸 Miami, Florida, United States

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States

Clinica Universidad de Navarra - Pamplona; 🇪🇸 Pamplona, Navarra, Spain

Centro Integral Oncologico Clara Campal; 🇪🇸 Madrid, Spain