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Cancer Vaccine

Adenovirus/PSA Vaccine for Prostate Cancer (APP22 Trial)

Phase 2
Waitlist Available
Led By David M Lubaroff, PhD
Research Sponsored by David M Lubaroff
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 every 6 months, up to 14 years
Awards & highlights

APP22 Trial Summary

This investigational study involves treatment with an Ad/PSA vaccine for men with prostate cancer who present with evidence of hormone refractory metastatic disease.

Eligible Conditions
  • Prostate Cancer

APP22 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 6 months, up to 14 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 6 months, up to 14 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants Who Develop a Strong or Modest Anti-PSA Immune Response
Number of Participants With Stable, Decreased, or Increased PSA Doubling Times (PSADT)
Secondary outcome measures
Number of Participants Alive and Deceased Following Treatment

Side effects data

From 2023 Phase 2 trial • 32 Patients • NCT00583024
16%
Cold and flu symptoms
13%
Headache
13%
Injection site irritation
9%
Fatigue
3%
Flushing
3%
Myalgia
3%
Pulmonary emboli
3%
Obstruction/stenosis of airway - Bronchus
3%
Cardiac ischemia/infarction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Adenovirus/PSA Vaccine

APP22 Trial Design

1Treatment groups
Experimental Treatment
Group I: Adenovirus/PSA VaccineExperimental Treatment1 Intervention
Participants will receive three injections of 0.16 ml. (0.125 ml. vaccine + 0.035 ml. Gelfoam) of the Ad/PSA subcutaneously
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ADENOVIRUS/PSA VACCINE
2007
Completed Phase 2
~40

Find a Location

Who is running the clinical trial?

David M LubaroffLead Sponsor
1 Previous Clinical Trials
50 Total Patients Enrolled
United States Department of DefenseFED
859 Previous Clinical Trials
225,371 Total Patients Enrolled
38 Trials studying Prostate Cancer
5,555 Patients Enrolled for Prostate Cancer
David M Lubaroff, PhDPrincipal InvestigatorUniversity of Iowa
1 Previous Clinical Trials
50 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Phase II Study of Adenovirus/PSA Vaccine in Men With Hormone - Refractory Prostate Cancer
David M Lubaroff 2007. "Phase II Study of Adenovirus/PSA Vaccine in Men With Hormone - Refractory Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00583024.
~2 spots leftby Apr 2025
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