Study on Treating Advanced Prostate Cancer with 177Lu-PSMA-617

Sponsor: Ebrahim S Delpassand

Sponsor score: 0

ClinicalTrials ID:NCT06972628

Provider View

This clinical trial is exploring the safety and effectiveness of the drug Pluvicto (177Lu-PSMA-617) in men with advanced prostate cancer that has spread to the bones, showing a 'super scan' pattern on bone scans. The study aims to find the best dose for these patients, who were not included in previous trials.

Patient Parameters

Program Overview

The purpose of this study is to test the safety and tolerability of Pluvicto (177Lu-PSMA-617) in men with metastatic castration-resistant prostate cancer (mCRPC) that has spread extensively to the bones, creating a 'super scan' pattern on bone scans. Although Pluvicto is already FDA-approved, this study focuses on patients who were not part of earlier research. Up to 30 men will participate, receiving a different initial dose than usual to find the best dose for this group. The study will help fill a gap in understanding how Pluvicto works in these specific patients.

Description

This study is investigating how safe and effective Pluvicto (Lu-177-PSMA617) is for men with advanced prostate cancer that has spread to the bones, showing a 'super scan' pattern. These patients were not included in previous studies, so this research aims to find the best safe dose using a method that starts with a low dose and gradually increases it. Participants will receive six doses, each given about six weeks apart. The main goals are to find the highest dose that can be tolerated and to monitor safety using specific criteria. The study will also look at how well the treatment works by checking PSA levels, quality of life, and overall survival. Up to 30 men will be part of the study, and more may join once the best dose is found. Regular lab tests and patient-reported side effects will be monitored, and long-term follow-up will continue every six months for up to five years. Imaging tests will be done at different stages to see how the cancer responds. Pluvicto is given through an IV infusion during each session, and participants may stop treatment if the cancer progresses, side effects are too severe, or for other medical reasons. This study is important for understanding how to safely use Pluvicto in a high-risk group of patients and may help guide future treatment decisions for prostate cancer.

Eligibility Criteria

Inclusion Criteria

  • Able to understand and sign a consent form.
  • Willing to follow study requirements.
  • Aged 18 years or older.
  • Have bone metastases with a 'super scan' pattern on a bone scan.
  • Have a performance status score of 0 to 2, meaning fully active or restricted in strenuous activity but ambulatory.
  • Hemoglobin level of at least 9.0 g/dL.
  • Platelet count of at least 90,000 per microliter.
  • White blood cell count of at least 2,000 per microliter and absolute neutrophil count over 1,500 per microliter without recent transfusions or growth factor support.
  • Normal kidney function with creatinine levels within 1.5 times the upper limit of normal.
  • Confirmed diagnosis of prostate cancer.
  • Positive PSMA PET/CT scan showing at least one PSMA-positive metastatic lesion.
  • Low testosterone levels (below 50 ng/dL).
  • Previously treated with at least one androgen receptor-targeted therapy.

Exclusion Criteria

  • Previous treatment with certain radiopharmaceuticals within six months before starting this study.
  • Prior PSMA-targeted radioligand therapy.
  • Recent systemic anti-cancer therapy within four weeks before the screening visit.
  • Known allergy to Pluvicto or its components.
  • Concurrent treatment with other cancer therapies.
  • Poor kidney function or low blood counts.
  • History of brain metastases unless treated and stable for six months.
  • Spinal cord compression symptoms.
  • Other cancers affecting life expectancy or study assessments, except for certain skin or bladder cancers.
  • Major surgery within 30 days before joining the study.
  • Plans to conceive or father a child during and up to six months after treatment.

Locations

FACILITYZIPCITYSTATE
Excel Diagnostics & Nuclear Oncology Center77042HoustonTexas

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