177Lu-PSMA-617 (Pluvicto) for the Treatment of Patients With Progressive PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC) and Super Scan Bone Scan
Ebrahim S Delpassand
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 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.
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 prostate cancer (mCRPC) who present with a "super scan" on bone scintigraphy-a pattern indicating widespread cancer in the bones. These patients were excluded from prior trials like the VISION study, leaving a critical gap in clinical understanding. The trial aims to identify the optimal safe dose of Pluvicto using a modified 3+3 dose-escalation method, beginning at a low dose that increases, and event…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
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.…
Interventions
- DrugAdministering Lutetium-177-PSMA-617 (PLUVICTO)
The study begins with a first cohort of three participants, each receiving a dose of 100 millicuries (mCi). After administration, participants are monitored for any dose-limiting toxicities (DLTs) during a predefined observation window. If fewer than two participants experience a DLT in a given cohort, the dose will be escalated for the next group. The dose escalation schedule is structured as follows: the second cohort receives 130 mCi (a 30% increase), the third cohort receives 162.5 mCi (a 25% increase), and the fourth cohort receives 200 mCi, a dose that is already FDA-approved and clinically accepted for mCRPC. This stepwise escalation continues until the 200 mCi dose is reached, or until two or more DLTs are observed in any cohort. If that occurs, escalation stops immediately, and the maximum tolerated dose is considered to be the previous lower dose. This becomes the optimal tolerated dose (OTD). After identifying the OTD, additional participants will be enrolled for treatment.
Location
- Excel Diagnostics & Nuclear Oncology CenterHouston, Texas