- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05751941
Study of Sipuleucel-T With or Without Continuing New Hormonal Agents in Metastatic Prostate Cancer
January 24, 2024 updated by: H. Lee Moffitt Cancer Center and Research Institute
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
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
26
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jingsong Zhang, MD, PhD
- Phone Number: 813-745-1363
- Email: Jingsong.Zhang@moffitt.org
Study Locations
-
-
Florida
-
Tampa, Florida, United States, 33612
- Recruiting
- Moffitt Cancer Center
-
Principal Investigator:
- Jingsong Zhang, MD, PhD
-
Contact:
- Juliet Bala
- Email: Juliet.Bala@moffitt.org
-
-
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.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
- 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
- Age 18 or above
- ECOG performance status 0 or 1
- Participants must have adequate organ and marrow function as defined below:
- Absolute neutrophil count ≥1,000/mcL
- Platelets ≥100,000/mcL
- Hemoglobin > 10 g/dl
- AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN
- Creatinine 1.5 ≤ institutional ULN
- Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
- For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
- 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
- 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
- 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
- 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
- Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
- Participants who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study
- Prior treatment with sipuleucel-T
- Participants who have not recovered from adverse events (AEs) due to prior anti-cancer therapy (i.e., have residual toxicities > Grade 2).
- Participants who require > 50% dose reduction of NHA are excluded from the study except for taking abiraterone at 250 mg with low fat food
- Documented brain metastases or liver metastases
- Treatment with any investigational compound within 30 days prior to the first dose of Sipuleucel-T
- Documented brain metastases or liver metastases
- 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
- 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
- Inability to comply with protocol requirements
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sipuleucel-T with NHA
Participants will continue taking New Hormonal Agents (NHA) while receiving sipuleucel-t as standard of care.
|
1000 mg of Abiraterone will be given orally daily plus prednisone 5-10 mg daily
160 mg of Enzalutamide will be given orally daily ending at week 4
Other Names:
240 mg of Apalutamide will be given orally daily ending at week 4
Sipuleucel-T is considered standard of care and will be infused into the participant three times at approximately 2-week intervals starting week 0, 2 and 4.
Other Names:
|
Experimental: Sipuleucel-T without NHA
Participants will discontinue use of New Hormonal Agents (NHA) while receiving sipuleucel-t as standard of care.
|
Sipuleucel-T is considered standard of care and will be infused into the participant three times at approximately 2-week intervals starting week 0, 2 and 4.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cumulative APC Activation
Time Frame: At Week 4
|
Cumulative APC activation is calculated as the sum of APC activation across 0, 2, and 4 weeks
|
At Week 4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to PSA progression
Time Frame: Up to week 44
|
PSA progression will be defined as the time from randomization to the first date of documented PSA progression based on the prostate cancer working group (PCWG) 3 criteria.
|
Up to week 44
|
Radiographic Progression Free Survival
Time Frame: Up to week 44
|
Radiographic Progression Free Survival (rPFS) as assessed by conventional CT and bone scan
|
Up to week 44
|
IgG Responses
Time Frame: At week 14
|
To evaluate increases in IgG levels after treatment, pre- and post treatment signal intensities from Luminex xMAP will be compared using a one-sided paired Wilcoxon signed-rank test.
To evaluate whether the fold changes in IgG levels after treatment were higher in the NHA group than the without NHA group, the values from the two groups will be compared using a one-sided Wilcoxon rank-sum test.
|
At week 14
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Jingsong Zhang, MD, PhD, Moffitt Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
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 Major Dates
Study Start (Actual)
February 14, 2023
Primary Completion (Estimated)
October 1, 2025
Study Completion (Estimated)
October 1, 2025
Study Registration Dates
First Submitted
February 21, 2023
First Submitted That Met QC Criteria
February 21, 2023
First Posted (Actual)
March 2, 2023
Study Record Updates
Last Update Posted (Actual)
January 26, 2024
Last Update Submitted That Met QC Criteria
January 24, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MCC-22003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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