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

Description

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

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Metastatic Castration-Resistant Prostate Cancer
Intervention / Treatment

-

Contacts and Locations

Houston

Excel Diagnostics & Nuclear Oncology Center, Houston, Texas, United States, 77042

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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).
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Ebrahim S Delpassand,

Ebrahim S. Delpassand, M.D. Chairman & Medical Director, MD., Nuclear Medicine, PRINCIPAL_INVESTIGATOR, Excel Diagnostics & Nuclear Oncology Center

Study Record Dates

2029-04-01