Study on Using Radiation and Pluvicto for Treating Locally Advanced Prostate Cancer

Sponsor: Angela Y. Jia, MD PhD

Sponsor score: 0

ClinicalTrials ID:NCT06574880

Provider View

This clinical trial is exploring whether using the drug Pluvicto instead of hormone therapy, along with radiation, can reduce the chance of prostate cancer returning while maintaining quality of life.

Patient Parameters

Program Overview

The aim of this study is to see if the drug Pluvicto, when used with radiation therapy, can lower the risk of prostate cancer coming back and help maintain quality of life. Participants will receive one dose of Pluvicto, followed by radiation therapy about 6 weeks later. The radiation will be given in 5 sessions over 2 weeks. A second dose of Pluvicto will be administered 6 weeks after the radiation is completed. Some participants may receive a third dose of Pluvicto, 6 weeks after the second dose.

Description

Prostate cancer is the most common cancer in men and a leading cause of cancer death. The usual treatment involves radiation therapy combined with long-term hormone therapy, which can have significant side effects and impact quality of life. This study is testing if Pluvicto can replace hormone therapy to reduce these side effects and improve treatment adherence. The trial will assess the safety of using Pluvicto with radiation therapy to the prostate and pelvic lymph nodes, aiming to improve cancer outcomes without the side effects of hormone therapy.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Good overall health with an ECOG performance status of 0 or 1.
  • Confirmed diagnosis of prostate adenocarcinoma.
  • Cancer must show a specific marker (PSMA) on scans, with a certain level of activity.
  • Must meet at least one of the following:
    • Cancer has spread to lymph nodes near the pelvis or further up.
    • If no lymph node spread, must have at least two of the following:
      • Advanced local tumor stage.
      • High-grade cancer.
      • PSA level of 40 ng/mL or higher.
  • Adequate organ and blood function, including:
    • Hemoglobin over 10 g/dL.
    • White blood cell count over 3000/mL.
    • Neutrophil count of at least 1,500/mcL.
    • Platelet count of at least 100,000/mcL.
    • Normal kidney and liver function.
  • Prostate symptoms score of 15 or less.
  • Medically fit and willing to follow up.
  • Able to understand and sign informed consent.
  • Agree to use barrier contraception and not donate sperm for 14 weeks after the last dose of Pluvicto.

Exclusion Criteria

  • Evidence of cancer spread beyond certain areas.
  • Prostate size over 90 cc.
  • Previous head and neck radiation.
  • Prior treatment for prostate cancer.
  • Use of certain medications within 30 days before the study.
  • Use of specific drugs 3 months before and during the study.
  • Previous pelvic radiation.
  • Participation in another drug study within 6 months.
  • History of another active cancer within 3 years, except certain skin or bladder cancers.
  • History of blood cancers.
  • History of Crohn's disease or ulcerative colitis.
  • Unable to undergo specific scans.
  • Any condition that would prevent participation according to the investigator.

Locations

FACILITYZIPCITYSTATE
University Hospitals Cleveland Medical Center Seidman Cancer Center, Case Comprehensive Cancer Center44106ClevelandOhio

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