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

Primary Purpose

Prostate Cancer, Metastatic Prostate Cancer

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Abiraterone
Enzalutamide
Apalutamide
Sipuleucel-T
Sponsored by
H. Lee Moffitt Cancer Center and Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring PSA Progression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Moffitt Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Sipuleucel-T with NHA

Sipuleucel-T without NHA

Arm Description

Participants will continue taking New Hormonal Agents (NHA) while receiving sipuleucel-t as standard of care.

Participants will discontinue use of New Hormonal Agents (NHA) while receiving sipuleucel-t as standard of care.

Outcomes

Primary Outcome Measures

Cumulative APC Activation
Cumulative APC activation is calculated as the sum of APC activation across 0, 2, and 4 weeks

Secondary Outcome Measures

Time to PSA progression
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.
Radiographic Progression Free Survival
Radiographic Progression Free Survival (rPFS) as assessed by conventional CT and bone scan
IgG Responses
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.

Full Information

First Posted
February 21, 2023
Last Updated
July 20, 2023
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
Dendreon
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1. Study Identification

Unique Protocol Identification Number
NCT05751941
Brief Title
Study of Sipuleucel-T With or Without Continuing New Hormonal Agents in Metastatic Prostate Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 14, 2023 (Actual)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
October 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
Dendreon

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Metastatic Prostate Cancer
Keywords
PSA Progression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sipuleucel-T with NHA
Arm Type
Experimental
Arm Description
Participants will continue taking New Hormonal Agents (NHA) while receiving sipuleucel-t as standard of care.
Arm Title
Sipuleucel-T without NHA
Arm Type
Experimental
Arm Description
Participants will discontinue use of New Hormonal Agents (NHA) while receiving sipuleucel-t as standard of care.
Intervention Type
Drug
Intervention Name(s)
Abiraterone
Intervention Description
1000 mg of Abiraterone will be given orally daily plus prednisone 5-10 mg daily
Intervention Type
Drug
Intervention Name(s)
Enzalutamide
Other Intervention Name(s)
Xtandi
Intervention Description
160 mg of Enzalutamide will be given orally daily ending at week 4
Intervention Type
Drug
Intervention Name(s)
Apalutamide
Intervention Description
240 mg of Apalutamide will be given orally daily ending at week 4
Intervention Type
Drug
Intervention Name(s)
Sipuleucel-T
Other Intervention Name(s)
Provenge
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cumulative APC Activation
Description
Cumulative APC activation is calculated as the sum of APC activation across 0, 2, and 4 weeks
Time Frame
At Week 4
Secondary Outcome Measure Information:
Title
Time to PSA progression
Description
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.
Time Frame
Up to week 44
Title
Radiographic Progression Free Survival
Description
Radiographic Progression Free Survival (rPFS) as assessed by conventional CT and bone scan
Time Frame
Up to week 44
Title
IgG Responses
Description
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.
Time Frame
At week 14

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jingsong Zhang, MD, PhD
Phone
813-745-1363
Email
Jingsong.Zhang@moffitt.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jingsong Zhang, MD, PhD
Organizational Affiliation
Moffitt Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juliet Bala
Email
Juliet.Bala@moffitt.org
First Name & Middle Initial & Last Name & Degree
Jingsong Zhang, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Links:
URL
https://moffitt.org/clinicaltrialssearch?DiseaseSite=&q=220033
Description
Moffitt Cancer Center Clinical Trial Search

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

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