NeoAdjuvant Theranostic Lutetium Study: The Nautilus Trial

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06066437

Provider View

This study is testing a new treatment using a drug called 177Lu rhPSMA-10.1 to see if it is safe for patients with high-risk, localized prostate cancer. The trial will also explore how this drug, alone or with hormone therapy, affects the cancer before surgery.

Patient Parameters

Program Overview

The purpose of this study is to determine if the drug 177Lu rhPSMA-10.1 is safe for patients with high-risk, localized prostate cancer. The study will also look at how this drug, with or without hormone therapy, affects the cancer before surgery to remove it.

Description

The main goal of this study is to check the safety of the drug 177Lu rhPSMA-10.1 and see how it affects the radiation dose to the tumor in patients with high-risk prostate cancer before surgery. The study will also look at how the drug, with or without hormone therapy, affects the cancer's appearance under a microscope and its activity on scans. Researchers will evaluate how well the treatment works in shrinking the cancer before surgery and explore potential markers that might predict the treatment's effectiveness.

Eligibility Criteria

Inclusion Criteria

  • Men aged 18 or older.
  • Diagnosed with high-risk or very high-risk prostate cancer based on specific medical criteria.
  • Recent prostate biopsy reviewed at MD Anderson Cancer Center.
  • Good overall health with a performance status score of 1.
  • No signs of cancer spread to other parts of the body based on specific scans.
  • Prostate tumor size of at least 1.5 cm³ on MRI.
  • Cancer must be considered removable by surgery.
  • No previous treatment for prostate cancer, including surgery, radiation, or chemotherapy.
  • Adequate blood cell counts and organ function based on specific tests.
  • Willing to provide blood samples for research purposes.
  • Able to attend clinic visits and follow study procedures.
  • Agree to use condoms during sexual activity and avoid sperm donation during and after the study.

Exclusion Criteria

  • Previous hormone therapy for prostate cancer.
  • Participation in another interventional study.
  • Use of certain medications like systemic corticosteroids before treatment.
  • Active infections requiring treatment, such as HIV or hepatitis.
  • Significant heart disease or recent heart-related events.
  • History of major implants or devices with complications.
  • Other cancers within the past two years, except for certain skin or bladder cancers.
  • Recent major surgery.
  • Previous organ or stem cell transplants.
  • Medical or psychological conditions that may interfere with the study.
  • Previous radiation treatment to the pelvis or certain other therapies.
  • Single functioning kidney or urinary obstruction.

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