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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 44
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to week 44
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 44
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cumulative APC Activation
Secondary outcome measures
IgG Responses
Radiographic Progression Free Survival
Time to PSA progression
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
~2830
Enzalutamide
2014
Completed Phase 4
~2760
Apalutamide
2015
Completed Phase 2
~3310
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
543 Previous Clinical Trials
135,469 Total Patients Enrolled
27 Trials studying Prostate Cancer
4,158 Patients Enrolled for Prostate Cancer
DendreonIndustry Sponsor
29 Previous Clinical Trials
5,117 Total Patients Enrolled
14 Trials studying Prostate Cancer
1,459 Patients Enrolled for Prostate Cancer
Jingsong Zhang, MD, PhDPrincipal InvestigatorMoffitt Cancer Center
2 Previous Clinical Trials
61 Total Patients Enrolled
1 Trials studying Prostate Cancer
31 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had chemotherapy or radiotherapy in the last 4 weeks.I have cancer that has spread to my brain or liver.I am a man who can father children and will use birth control during the study.You have taken an experimental medication within 30 days before starting treatment with Sipuleucel-T.My heart functions well despite a history of heart issues.I have another cancer type, but it won't affect this trial's treatment.I had hepatitis C but am cured, or I'm being treated with no detectable virus.I am HIV positive and not on antiretroviral therapy.I am 18 years old or older.I still have significant side effects from previous cancer treatments.I am fully active or can carry out light work.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.My hepatitis B virus load is undetectable with treatment.I am not on a reduced dose of my medication, except for abiraterone at 250 mg with low-fat food.I am on hormone therapy for prostate cancer that has spread, with rising PSA but no growth on scans.I have been treated with sipuleucel-T before.I am HIV positive, on treatment, and my viral load is undetectable.My prostate cancer is spreading but doesn't cause severe symptoms, and it was confirmed by a biopsy.My blood counts and kidney and liver functions are within normal ranges.
Research Study Groups:
This trial has the following groups:- Group 1: Sipuleucel-T with NHA
- Group 2: Sipuleucel-T without NHA
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research endeavor presently looking for participants?
"Clinicaltrials.gov confirms that this trial is accepting participants, having gone online on February 14th 2023 and been amended for the last time a week later."
Answered by AI
What is the maximum number of participants that have been accepted in this research program?
"Correct. Clinicaltrials.gov yields information that this clinical trial, which was made available on February 14th 2023, is still open to enrolment. 26 participants need to be admitted at one medical centre."
Answered by AI
What risks should be taken into account when utilizing Sipuleucel-T in combination with NHA?
"Our company's assessment of sipuleucel-T with NHA is a 2 as it has yet to be proven effective in clinical trials, however there are some reports that suggest its safety."
Answered by AI
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