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Cancer Vaccine

Cellular Immunotherapy for Prostate Cancer (OUSCCEXCITE Trial)

Phase 1
Recruiting
Led By Kelly Stratton, MD
Research Sponsored by University of Oklahoma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial suggests a longer course of Sipuleucel-T treatment may help fight mCRPC more effectively.

Who is the study for?
This trial is for men over 18 with advanced prostate cancer that has spread, who haven't had Sipuleucel-T before and are expected to live at least another 6 months. They should be fairly active (able to care for themselves) and not have other cancers needing treatment soon or serious infections recently.
What is being tested?
The study tests if giving more doses of the immunotherapy drug Sipuleucel-T can boost the immune system better to fight metastatic Castration-Resistant Prostate Cancer than the standard treatment course.
What are the potential side effects?
Sipuleucel-T may cause flu-like symptoms such as fever, chills, fatigue, nausea, joint aches, and headache. Some might experience infusion-related reactions including breathing problems or high blood pressure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of patients completing 3 doses of Sipuleucel-T immunotherapy.
Proportion of subjects who have detectable elevated IgG level and/or T-cell proliferation from baseline to the follow-up of extended course of Sipuleucel-T immunotherapy.
Secondary study objectives
Evaluate the mean difference in immune response to Sipuleucel-T treatment among different racial groups.
Evaluate the potential tumor response based on the changes in serum PSA at baseline and within 30 days of last dose.

Side effects data

From 2009 Phase 3 trial • 512 Patients • NCT00065442
54%
Chills
39%
Fatigue
34%
Back pain
29%
Pyrexia
28%
Nausea
21%
Arthralgia
20%
Citrate toxicity
18%
Vomiting
16%
Headache
15%
Anaemia
14%
Pain in extremity
14%
Dizziness
13%
Constipation
13%
Pain
13%
Paraesthesia
13%
Musculoskeletal pain
12%
Paraesthesia oral
11%
Diarrhoea
11%
Asthenia
10%
Musculoskeletal chest pain
10%
Influenza like illness
10%
Myalgia
9%
Haematuria
9%
Bone pain
9%
Oedema peripheral
8%
Dyspnoea
7%
Insomnia
7%
Muscles spasms
7%
Hypertension
7%
Urinary tract infection
7%
Anorexia
6%
Weight decreased
6%
Neck pain
6%
Decreased appetite
5%
Hyperhidrosis
5%
Hypoaesthesia
5%
Hypotension
5%
Rash
4%
Hydronephrosis
4%
Upper respiratory tract infection
4%
Anxiety
3%
Contusion
3%
Flank pain
2%
Depression
2%
Cerebrovascular accident
1%
Transient ischaemic attack
1%
Pneumonia
1%
Muscular weakness
1%
Prostate cancer metastatic
1%
Spinal cord compression
1%
Pulmonary embolism
1%
Acute myocardial infarction
1%
Atrial fibrillation
1%
Cardiac failure congestive
1%
Catheter bacteraemia
1%
Catheter sepsis
1%
Subdural haematoma
1%
Dehydration
1%
Intestinal obstruction
100%
80%
60%
40%
20%
0%
Study treatment Arm
APC-Placebo
Sipuleucel-T

Awards & Highlights

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

Trial Design

1Treatment groups
Experimental Treatment
Group I: Extended course of Sipuleucel-T treatmentExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sipuleucel-T
2017
Completed Phase 3
~890

Find a Location

Who is running the clinical trial?

University of OklahomaLead Sponsor
473 Previous Clinical Trials
93,669 Total Patients Enrolled
3 Trials studying Prostate Cancer
358 Patients Enrolled for Prostate Cancer
DendreonIndustry Sponsor
29 Previous Clinical Trials
5,213 Total Patients Enrolled
15 Trials studying Prostate Cancer
1,485 Patients Enrolled for Prostate Cancer
Kelly Stratton, MDPrincipal InvestigatorInvestigator
1 Previous Clinical Trials
18 Total Patients Enrolled

Media Library

Sipuleucel-T (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05806814 — Phase 1
Prostate Cancer Research Study Groups: Extended course of Sipuleucel-T treatment
Prostate Cancer Clinical Trial 2023: Sipuleucel-T Highlights & Side Effects. Trial Name: NCT05806814 — Phase 1
Sipuleucel-T (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05806814 — Phase 1
~6 spots leftby Nov 2025
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