Actively Recruiting
Treatment of Patients With Progressive mCRPC With 177Lu-PSMA-617
Led by Ebrahim S Delpassand · Updated on 2025-05-15
30
Participants Needed
1
Research Sites
201 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Treatment of Patients With Progressive mCRPC With 177Lu-PSMA-617
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and sign an informed consent form
- Willingness and ability to comply with study requirements
- Age 18 years or older
- Presence of skeletal metastases with a superscan pattern on a 99mTc-MDP/HDP bone scan
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Hemoglobin 9.0 g/dL or higher
- Platelet count 90 x 10^9/L or higher
- White blood cell count 2.0 x 10^9/L or higher and absolute neutrophil count over 1.5 x 10^9/L without recent transfusions or growth factor support
- Serum/plasma creatinine at or below 1.5 times the upper limit of normal
- 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 below 50 ng/dL or 1.7 nmol/L
- Prior treatment with at least one androgen receptor-axis-targeted therapy (ARAT)
You will not qualify if you...
- Prior treatment with radiopharmaceuticals within six months before study treatment
- Prior PSMA-targeted radioligand therapy
- Systemic anti-cancer therapy within four weeks before screening
- Known hypersensitivity to PLUVICTO or its components
- Concurrent treatment with other chemotherapy, immunotherapy, radioligand, or investigational therapies
- Renal impairment with estimated glomerular filtration rate below 60 mL/min
- Hemoglobin below 9 g/dL, ANC below 1.5 x 10^9/L, or platelets below 90 x 10^9/L
- History of CNS metastases unless treated and stable for 6 months without corticosteroids
- Symptomatic or impending spinal cord compression
- Other active malignancies impacting life expectancy except treated non-melanoma skin or superficial bladder cancer
- Major surgery within 30 days prior to enrollment
- Plans to conceive or father a child during treatment and for six months after treatment
AI-Screening
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Trial Site Locations
Total: 1 location
1
Excel Diagnostics & Nuclear Oncology Center
Houston, Texas, United States, 77042
Actively Recruiting
Research Team
S
Susan Cork Therapy Coordinator
CONTACT
N
Nereyda Sauceda, Therapy Coordinator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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