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

Korábbi kezelés

• 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.
• Prior PSMA-targeted radioligand therapy.
• Systemic anti-cancer therapy (e.g., chemotherapy, immunotherapy, monoclonal antibodies) within four weeks before screening visit.
• Concurrent treatment with other cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy.
• Major surgery within 30 days prior to enrollment.

Más betegség

• Known hypersensitivity to PLUVICTO or its components.
• History of CNS metastases unless treated and stable for 6 months, with no ongoing corticosteroid use.
• 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.

Laborértékek

• Renal impairment (estimated glomerular filtration rate <60 mL/min), hemoglobin <9 g/dL, ANC <1.5 × 10⁹/L, or platelets < 90 × 10⁹/L.

Egyéb

• Symptomatic or impending spinal cord compression.
• Plans to conceive or father a child during treatment and up to six months post-treatment.

• Ability to understand and sign an informed consent form (ICF).
• Willingness and ability to comply with study requirements.
• Age ≥18 years.
• 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.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
• Hemoglobin ≥9.0 g/dL.
• Platelet count ≥90 × 10⁹/L.
• 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).
• Serum/plasma creatinine ≤1.5 × upper limit of normal (ULN).
• Histological, pathological, or cytological confirmation of prostate cancer.
• Positive PSMA PET/CT scan showing at least one PSMA-positive metastatic lesion.
• Castrate-level serum/plasma testosterone (<50 ng/dL or <1.7 nmol/L).
• Prior treatment with at least one androgen receptor-axis-targeted therapy (ARAT).