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Cancer Vaccine

Sipuleucel-T + Hormonal Therapy for Prostate Cancer

Phase 2
Recruiting
Led By Jingsong Zhang, MD, PhD
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Age 18 or above
Must not have
Documented brain metastases or liver metastases
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 44
Awards & highlights
No Placebo-Only Group

Summary

This trial studies if a new treatment for prostate cancer works better than existing treatment alone.

Who is the study for?
This trial is for men over 18 with metastatic prostate cancer that's not causing severe symptoms. They must be on hormone therapy and have a rising PSA level but no new cancer spread on scans. Participants need good organ function, controlled HIV if present, and can't have had recent chemotherapy or radiotherapy, prior Sipuleucel-T treatment, significant heart issues, or other serious illnesses.
What is being tested?
The study tests whether combining Sipuleucel-T (Provenge) with new hormonal agents like abiraterone, enzalutamide, or apalutamide improves immune system activation in men with advanced prostate cancer without visceral metastases. It aims to see if this combination can better target the cancer cells.
What are the potential side effects?
Sipuleucel-T may cause flu-like symptoms such as fever and chills; back pain; joint ache; nausea; headache. Hormonal agents might lead to fatigue; hot flashes; high blood pressure; liver issues and could affect mood or sexual function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I had hepatitis C but am cured, or I'm being treated with no detectable virus.
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I am 18 years old or older.
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I am fully active or can carry out light work.
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My hepatitis B virus load is undetectable with treatment.
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I am on hormone therapy for prostate cancer that has spread, with rising PSA but no growth on scans.
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My prostate cancer is spreading but doesn't cause severe symptoms, and it was confirmed by a biopsy.
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My blood counts and kidney and liver functions are within normal ranges.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have cancer that has spread to my brain or liver.
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I am HIV positive and not on antiretroviral therapy.
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I still have significant side effects from previous cancer treatments.
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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.
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I have been treated with sipuleucel-T before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 44
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 44 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Cumulative APC Activation
Secondary study objectives
IgG Responses
Radiographic Progression Free Survival
Time to PSA progression

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Sipuleucel-T without NHAExperimental Treatment1 Intervention
Participants will discontinue use of New Hormonal Agents (NHA) while receiving sipuleucel-t as standard of care.
Group II: Sipuleucel-T with NHAExperimental Treatment4 Interventions
Participants will continue taking New Hormonal Agents (NHA) while receiving sipuleucel-t as standard of care.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abiraterone
2012
Completed Phase 4
~4480
Enzalutamide
2014
Completed Phase 4
~3820
Apalutamide
2015
Completed Phase 2
~5750
Sipuleucel-T
2017
Completed Phase 3
~890

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
567 Previous Clinical Trials
144,869 Total Patients Enrolled
26 Trials studying Prostate Cancer
4,133 Patients Enrolled for Prostate Cancer
DendreonIndustry Sponsor
29 Previous Clinical Trials
5,199 Total Patients Enrolled
14 Trials studying Prostate Cancer
1,459 Patients Enrolled for Prostate Cancer
Jingsong Zhang, MD, PhDPrincipal InvestigatorMoffitt Cancer Center
3 Previous Clinical Trials
87 Total Patients Enrolled
1 Trials studying Prostate Cancer
32 Patients Enrolled for Prostate Cancer

Media Library

Sipuleucel-T (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05751941 — Phase 2
Prostate Cancer Research Study Groups: Sipuleucel-T with NHA, Sipuleucel-T without NHA
Prostate Cancer Clinical Trial 2023: Sipuleucel-T Highlights & Side Effects. Trial Name: NCT05751941 — Phase 2
Sipuleucel-T (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05751941 — Phase 2
~9 spots leftby Dec 2025
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