Study on Sipuleucel-T With or Without Continuing New Hormonal Agents in Metastatic Prostate Cancer

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05751941

Provider View

This clinical trial is exploring whether combining Sipuleucel-T with new hormonal agents can improve treatment for men with metastatic prostate cancer that has not spread to major organs and is not causing symptoms.

Patient Parameters

Program Overview

The study aims to find out if using Sipuleucel-T (Provenge) together with new hormonal agents like abiraterone, enzalutamide, or apalutamide can better activate certain immune cells in men with metastatic prostate cancer that is resistant to standard hormone therapy but not causing symptoms or spreading to major organs.

Eligibility Criteria

Inclusion Criteria

  • Have metastatic prostate cancer that is not causing symptoms and has been confirmed by a biopsy.
  • Currently receiving hormone therapy with LHRH analog and a new hormonal agent (enzalutamide, apalutamide, or abiraterone) for prostate cancer that shows PSA progression but no imaging progression.
  • Be 18 years or older.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Have adequate organ and bone marrow function, including:
    • Neutrophil count of at least 1,000/mcL.
    • Platelet count of at least 100,000/mcL.
    • Hemoglobin level above 10 g/dl.
    • Liver enzymes (AST/ALT) within three times the normal limit.
    • Creatinine level within 1.5 times the normal limit.
  • HIV-positive participants on effective therapy with undetectable viral load are eligible.
  • Participants with controlled hepatitis B or cured hepatitis C are eligible.
  • Participants with other cancers that do not interfere with the study are eligible.
  • No uncontrolled heart rhythm problems, and heart function must be above 40%.
  • Non-sterilized men must agree to use contraception during the study.
  • Must understand and agree to sign a consent form.

Exclusion Criteria

  • Have received chemotherapy or radiotherapy within the last 4 weeks.
  • Have previously been treated with Sipuleucel-T.
  • Have not fully recovered from side effects of previous cancer treatments.
  • Require more than a 50% dose reduction of new hormonal agents, except for taking abiraterone at 250 mg with low-fat food.
  • Have brain or liver metastases.
  • Have taken any investigational drugs within 30 days before starting Sipuleucel-T.
  • Have uncontrolled illnesses, such as active infections, heart failure, unstable chest pain, or psychiatric conditions that would affect study participation.
  • Have a known history of HIV or AIDS and are not eligible if on antiretroviral therapy.
  • Unable to comply with study requirements.

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