RECRUITING

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

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Conditions

Prostate CancerMetastatic Prostate CancerPSA Progression

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study is designed to test the hypothesis that using Sipuleucel-T (Provenge) in combination with new hormonal agents (NHA) (abiraterone, enzalutamide, apalutamide) for the treatment of participants with asymptomatic metastatic castration resistant prostate cancer (mCRPC) and no visceral metastases would enhance the activation of antigen presenting cells (APC) by sipuleucel-T.

Official Title

A Phase II Randomized Study of Sipuleucel-T With or Without Continuing New Hormonal Agents (NHA) in Metastatic Prostate Cancer With PSA Progression While on NHA and LHRH Analog

Quick Facts

Study Start:2023-02-14
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05751941

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Asymptomatic or minimally symptomatic metastatic prostate cancer, and the diagnosis of prostate cancer needs to be histologically confirmed by biopsy of the prostate or a metastatic lesion
  2. * On combined ADT with LHRH analog and a NHA (enzalutamide, apalutamide or abiraterone) for metastatic prostate cancer with PSA progression, but no imaging progression based on the prostate cancer working group (PCWG) 3 criteria
  3. * Age 18 or above
  4. * ECOG performance status 0 or 1
  5. * Participants must have adequate organ and marrow function as defined below:
  6. * Absolute neutrophil count ≥1,000/mcL
  7. * Platelets ≥100,000/mcL
  8. * Hemoglobin \> 10 g/dl
  9. * AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN
  10. * Creatinine 1.5 ≤ institutional ULN
  11. * Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
  12. * For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
  13. * Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
  14. * Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of sipuleucel-T are eligible for this trial
  15. * No uncontrolled arrhythmia: patients with h/o myocardial infarction or history of congestive heart failure, need to have estimated left ventricle ejection fraction above 40% either on echocardiogram or MUGA scan within 6 months of study enrollment
  16. * Non-sterilized men who are sexually active with a female partner of childbearing potential must agree to use adequate contraception prior to the study enrollment, and for the duration of study participation
  17. * Ability to understand and the willingness to sign a written informed consent document
  1. * Participants who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study
  2. * Prior treatment with sipuleucel-T
  3. * Participants who have not recovered from adverse events (AEs) due to prior anti-cancer therapy (i.e., have residual toxicities \> Grade 2).
  4. * Participants who require \> 50% dose reduction of NHA are excluded from the study except for taking abiraterone at 250 mg with low fat food
  5. * Documented brain metastases or liver metastases
  6. * Treatment with any investigational compound within 30 days prior to the first dose of Sipuleucel-T
  7. * Documented brain metastases or liver metastases
  8. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  9. * Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome. HIV-positive participants on combination antiretroviral therapy are ineligible because of the potential for sipluleucel-T to be less clinically active in this population
  10. * Inability to comply with protocol requirements

Contacts and Locations

Study Contact

Jingsong Zhang, MD, PhD
CONTACT
813-745-1363
Jingsong.Zhang@moffitt.org

Principal Investigator

Jingsong Zhang, MD, PhD
PRINCIPAL_INVESTIGATOR
Moffitt Cancer Center

Study Locations (Sites)

Moffitt Cancer Center
Tampa, Florida, 33612
United States

Collaborators and Investigators

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

  • Jingsong Zhang, MD, PhD, PRINCIPAL_INVESTIGATOR, Moffitt Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-14
Study Completion Date2025-12

Study Record Updates

Study Start Date2023-02-14
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • PSA Progression

Additional Relevant MeSH Terms

  • Prostate Cancer
  • Metastatic Prostate Cancer