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

NCT05751941 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: MCC-22003
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 2

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.

Conditions

Prostate Cancer; Metastatic Prostate Cancer

Keywords

PSA Progression

Outcome Measures

Primary Outcomes (1)

• Cumulative APC Activation

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

  At Week 4

Secondary Outcomes (3)

• Time to PSA progression

  Up to week 44

• Radiographic Progression Free Survival

  Up to week 44

• IgG Responses

  At week 14

Study Arms (2)

Sipuleucel-T with NHA

EXPERIMENTAL

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

Drug: Abiraterone; Drug: Enzalutamide; Drug: Apalutamide; Drug: Sipuleucel-T

Sipuleucel-T without NHA

EXPERIMENTAL

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

Drug: Sipuleucel-T

Interventions

Abiraterone DRUG

1000 mg of Abiraterone will be given orally daily plus prednisone 5-10 mg daily

Sipuleucel-T with NHA

Enzalutamide DRUG

160 mg of Enzalutamide will be given orally daily ending at week 4

Also known as: Xtandi

Sipuleucel-T with NHA

Apalutamide DRUG

240 mg of Apalutamide will be given orally daily ending at week 4

Sipuleucel-T with NHA

Sipuleucel-T DRUG

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.

Also known as: Provenge

Sipuleucel-T with NHA; Sipuleucel-T without NHA

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• Dendreon: collaborator

Study Sites (2)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

RECRUITING

Related Links

• Moffitt Cancer Center Clinical Trial Search

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

abiraterone; enzalutamide; apalutamide; sipuleucel-T

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Jingsong Zhang, MD, PhD

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jingsong Zhang, MD, PhD

CONTACT

813-745-1363; Jingsong.Zhang@moffitt.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: March 2, 2023
• Study Start: February 14, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-02

Locations

US (2)