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

NCT05751941 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2026-03-16

No results posted yet for this study

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

Interventions

DRUG

Abiraterone

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

DRUG

Enzalutamide

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

DRUG

Apalutamide

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

DRUG

Sipuleucel-T

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.

Sponsors & Collaborators

  • Dendreon

    collaborator INDUSTRY

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Jingsong Zhang, MD, PhD · Moffitt Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-14
Primary Completion
2026-10-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05751941 on ClinicalTrials.gov