Using Lutetium treatments for advanced prostate cancer

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

This study tests two Lutetium-based treatments for advanced prostate cancer to see if they can effectively target cancer cells in patients who are getting ready for radioligand therapy.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 60 Years and up
• Sex: Male
• Sponsor: Blue Earth Therapeutics Ltd (Industry-sponsored)
• Locations: 5 sites (Miami, Florida and 4 other locations)
• Trial ID: NCT06516510 on ClinicalTrials.gov

What this trial studies

This study investigates the dosimetry of two Lutetium-based treatments, rhPSMA 10.1 and Pluvicto®, in patients with non-curative metastatic prostate cancer. It is a randomized, multi-center, intra-patient imaging study that aims to assess the effectiveness of these therapies in targeting PSMA-positive lesions. Patients will undergo imaging and dosimetry assessments to evaluate the potential benefits of these treatments. The study focuses on patients who are undergoing or planning for radioligand therapy.

Who should consider this trial

Good fit: Ideal candidates are male patients aged 60 years or older with non-curative PSMA-positive metastatic prostate cancer.

Not a fit: Patients with prostate cancer that is not PSMA-positive or those who do not meet the eligibility criteria will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new targeted treatment option for patients with advanced prostate cancer.

How similar studies have performed: Other studies using Lutetium-based therapies have shown promise, indicating potential for success in this approach.

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

Where this trial is running

Miami, Florida and 4 other locations

• Biogenix Molecular — Miami, Florida, United States (Recruiting)
• Emory University Hospital — Atlanta, Georgia, United States (Recruiting)
• Radboud UMC — Nijmegen, Gelderland, Netherlands (Recruiting)
• Clinica Universidad de Navarra - Pamplona — Pamplona, Navarra, Spain (Recruiting)
• Centro Integral Oncologico Clara Campal — Madrid, Spain (Recruiting)

Study contacts

• Study coordinator: Blue Earth Therapeutics

Conditions Metastatic Prostate Cancer