Treatment of Patients With Progressive mCRPC With 177Lu-PSMA-617

Launched by EBRAHIM S DELPASSAND · May 12, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Lutetium-177-PSMA-617, or Pluvicto, for men with metastatic castration-resistant prostate cancer (mCRPC) who have extensive bone metastases, specifically those showing a "super scan" pattern on a bone scan. The main goal of the study is to evaluate how safe and well-tolerated this treatment is for these patients, as they were previously excluded from earlier studies. The researchers will enroll up to 30 men aged 18 or older who meet specific health criteria and have already received at least one other treatment for their prostate cancer.

Participants in the trial can expect to receive a different starting dose of Pluvicto than what is typically used, and the study will closely monitor their health and response to the treatment. To join, men must have certain health conditions and test results, including having visible bone metastases on scans and specific blood counts. This trial aims to fill an important knowledge gap about how effective Pluvicto is for patients with the unique "super scan" pattern, which may help improve treatment options for this group in the future.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Ability to understand and sign an informed consent form (ICF).
• • 2. Willingness and ability to comply with study requirements.
• • 3. Age ≥18 years.
• • 4. Presence of skeletal metastases with a superscan pattern on a 99mTc-MDP/HDP bone scan, defined by significantly increased skeletal radioisotope uptake relative to soft tissues and faint or absent renal activity.
• • 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
• • 6. Hemoglobin ≥9.0 g/dL.
• • 7. Platelet count ≥90 × 10⁹/L.
• • 8. White blood cell count ≥2.0 × 10⁹/L, absolute neutrophil count (ANC) \>1.5 × 10⁹/L.
• • o These hematologic criteria must be met without recent transfusions (within 28 days prior to the first study treatment) or growth factor support (within 21 days).
• • 9. Serum/plasma creatinine ≤1.5 × upper limit of normal (ULN).
• • 10. Histological, pathological, or cytological confirmation of prostate cancer.
• • 11. Positive PSMA PET/CT scan showing at least one PSMA-positive metastatic lesion.
• • 12. Castrate-level serum/plasma testosterone (\<50 ng/dL or \<1.7 nmol/L).
• • 13. Prior treatment with at least one androgen receptor-axis-targeted therapy (ARAT).
• Exclusion Criteria:
• • 1. Prior treatment with radiopharmaceuticals (e.g., Strontium-89, Samarium-153, Rhenium- 186, Rhenium-188, Radium-223, hemi-body irradiation) within six months before start of treatment under this protocol.
• • 2. Prior PSMA-targeted radioligand therapy.
• • 3. Systemic anti-cancer therapy (e.g., chemotherapy, immunotherapy, monoclonal antibodies) within four weeks before screening visit.
• • 4. Known hypersensitivity to PLUVICTO or its components.
• • 5. Concurrent treatment with other cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy.
• • 6. Renal impairment (estimated glomerular filtration rate \<60 mL/min), hemoglobin \<9 g/dL, ANC \<1.5 × 10⁹/L, or platelets \< 90 × 10⁹/L.
• • 7. History of CNS metastases unless treated and stable for 6 months, with no ongoing corticosteroid use.
• • 8. Symptomatic or impending spinal cord compression.
• • 9. Other malignancies impacting life expectancy or interfering with study assessments. Exceptions include non-melanoma skin cancer or superficial bladder cancer that has been adequately treated.
• • 10. Major surgery within 30 days prior to enrollment.
• • 11. Plans to conceive or father a child during treatment and up to six months post-treatment.