💬In plain words
What the trial is, and whether it could suit you
The purpose of this study is to evaluate the safety and tolerability of Lutetium-177-PSMA-617 (PLUVICTO) in patients with metastatic castration-resistant prostate cancer (mCRPC) and extensive bone metastases, which appear as a "super scan" pattern on a bone scan.
Pluvicto is FDA-approved, but patients with super scan bone scans were previously excluded from the VISION clinical trial, leaving a knowledge gap.
The study will enroll up to 30 men with metastatic castration-resistant prostate cancer, with an initial dosing approach that differs from the standard dose.
The safety and tolerability of PLUVICTO will be evaluated in this study, with a focus on identifying the optimal dose for this population.
This study addresses an important gap in understanding how Pluvicto performs in mCRPC patients with super scan findings.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
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