Status:
RECRUITING
Treatment of Patients With Progressive mCRPC With 177Lu-PSMA-617
Lead Sponsor:
Ebrahim S Delpassand
Conditions:
Metastatic Castration-Resistant Prostate Cancer
Prostate Cancer Patients With Bone Metastasis
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
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 met...
Detailed Description
This clinical study investigates the safety and effectiveness of the FDA-approved drug Pluvicto (Lu-177-PSMA617). It focuses on a unique group of patients with metastatic castration-resistant prostat...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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.
- Known hypersensitivity to PLUVICTO or its components.
- Concurrent treatment with other cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy.
- Renal impairment (estimated glomerular filtration rate \<60 mL/min), hemoglobin \<9 g/dL, ANC \<1.5 × 10⁹/L, or platelets \< 90 × 10⁹/L.
- History of CNS metastases unless treated and stable for 6 months, with no ongoing corticosteroid use.
- Symptomatic or impending spinal cord compression.
- 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.
- Major surgery within 30 days prior to enrollment.
- Plans to conceive or father a child during treatment and up to six months post-treatment.
Key Trial Info
Start Date :
May 23 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2029
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06972628
Start Date
May 23 2025
End Date
April 1 2029
Last Update
May 15 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Excel Diagnostics & Nuclear Oncology Center
Houston, Texas, United States, 77042