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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
OUSCCEXCITE Trial 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.Check my eligibility
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.See study design
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.
OUSCCEXCITE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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 • NCT0006544254%
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%
Hypertension
7%
Muscles spasms
7%
Urinary tract infection
7%
Anorexia
6%
Weight decreased
6%
Neck pain
6%
Decreased appetite
5%
Hyperhidrosis
5%
Hypotension
5%
Hypoaesthesia
5%
Rash
4%
Hydronephrosis
4%
Upper respiratory tract infection
4%
Anxiety
3%
Contusion
3%
Flank pain
2%
Depression
2%
Cerebrovascular accident
1%
Pulmonary embolism
1%
Prostate cancer metastatic
1%
Transient ischaemic attack
1%
Muscular weakness
1%
Pneumonia
1%
Spinal cord compression
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
OUSCCEXCITE 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
455 Previous Clinical Trials
95,911 Total Patients Enrolled
2 Trials studying Prostate Cancer
110 Patients Enrolled for Prostate Cancer
DendreonIndustry Sponsor
29 Previous Clinical Trials
5,131 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have cancer other than prostate cancer that won't need treatment in the next 6 months.I am a man aged 18 or older.I have previously received Provenge® treatment.I have not taken antibiotics for an infection in the week before signing up.My prostate cancer has spread to other parts of my body.I am fully active or restricted in physically strenuous activity but can do light work.I have prostate cancer that has spread and is resistant to hormonal therapy, but I don't have severe symptoms.I am on a daily immunosuppressive therapy stronger than 10mg of Prednisone.
Research Study Groups:
This trial has the following groups:- Group 1: Extended course of Sipuleucel-T treatment
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 study currently accepting participants?
"As evidenced by the clinicaltrials.gov database, this medical trial is no longer in its recruitment phase since it was last updated on March 28th 2023. However, there are 1252 other trials currently recruiting patients."
Answered by AI
Has the administration approved a prolonged course of Sipuleucel-T therapies?
"As this is a Phase 1 trial, there is only limited evidence of safety and efficacy for extended course Sipuleucel-T treatment; thus our team at Power assigned it the lowest risk rating score of 1."
Answered by AI
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