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

NCT06516510 | Terminated Early Phase 1 FDA Drug

• 1 other identifier: BET-PSMA-001
• Study Type: interventional
• Target: 17
• Locations: 3 countries
• Sites: 6

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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 compare the tumour and normal organ effective half lives of lutetium (177Lu) rhPSMA 10.1 and lutetium (177Lu) vipivotide tetraxetan.

  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

Study Arms (2)

Sequence A

OTHER

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

Drug: lutetium (177Lu) rhPSMA 10.1 and Pluvicto®

Sequence B

OTHER

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

Drug: lutetium (177Lu) rhPSMA 10.1 and Pluvicto®

Interventions

lutetium (177Lu) rhPSMA 10.1 and Pluvicto® DRUG

Radiopharmaceutical

Sequence A; Sequence B

Eligibility Criteria

• Age: 60 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Blue Earth Therapeutics Ltd: lead
• Medpace, Inc.: collaborator

Study Sites (6)

Biogenix Molecular LLC

Miami, Florida, 33165, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Radboud UMC

Nijmegen, Gelderland, 6525GA, Netherlands

Location

Centro Integral Oncologico Clara Campal

Madrid, Madrid, 28050, Spain

Location

Clinica Universidad de Navarra - Pamplona

Pamplona, Navarre, 31008, Spain

Location

Clinica Universidad de Navarra

Madrid, 28027, Spain

Location

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

Study Officials

• Blue Earth Therapeutics

  Blue Earth Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: July 24, 2024
• Study Start: October 31, 2024
• Primary Completion: August 15, 2025
• Study Completion: August 15, 2025
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1); US (2); ES (3)