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RECRUITING

NCT06972628

PHASE2

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

Sponsor: Ebrahim S Delpassand

View on ClinicalTrials.gov

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.

Official title: 177Lu-PSMA-617 (Pluvicto) for the Treatment of Patients With Progressive PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC) and Super Scan Bone Scan

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-05-23

Completion Date

2029-04-01

Last Updated

2025-05-15

Healthy Volunteers

Conditions

Metastatic Castration-Resistant Prostate Cancer Prostate Cancer Patients With Bone Metastasis Prostate Cancer (CRPC)Prostate Cancer Prostate Cancer Metastatic

Interventions

DRUG

Administering 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.

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.

Locations (1)

Excel Diagnostics & Nuclear Oncology Center

Houston, Texas, United States