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Virus Therapy

Adenovirus/PSA Vaccine for Prostate Cancer (APP21 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

APP21 Trial Summary

The purpose of this study is to determine whether vaccination with the Ad/PSA vaccine will induce an anti-PSA immunity that will result in the destruction of the remaining prostate cancer cells.

Eligible Conditions
  • Prostate Cancer

APP21 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
Secondary outcome measures
Number of Participants Alive and Deceased Following Treatment
Number of Participants With Stable, Decreased, or Increased PSA Doubling Times (PSADT)

Side effects data

From 2023 Phase 2 trial • 50 Patients • NCT00583752
44%
Hot flashes
8%
Decreased libido
8%
Headache
4%
Facial flushing
4%
Injection site reaction
4%
Sleeplessness
4%
Upper airway infection
4%
Fatigue
4%
Increased urinary frequency
4%
Increased urinary urgency
4%
Increased erectile dysfunction
4%
Epigastric pain
4%
Flu
4%
Shortness of breath
4%
Stomach ache
4%
Elevated ALT
4%
Elevated AST
4%
Leg cramp
4%
Basal cell cancer
4%
Metabolic, other
4%
Diarrhea
4%
Myositis
4%
Gynecomastia
4%
Cardiac pain
4%
Cerebrovascular accident
4%
Elevated LDH
4%
Eye hemorrhage
4%
Nose bleed
100%
80%
60%
40%
20%
0%
Study treatment Arm
Androgen Deprivation Therapy (ADT) + Adenovirus/PSA Vaccine
Adenovirus/PSA Vaccin

APP21 Trial Design

2Treatment groups
Experimental Treatment
Group I: Androgen deprivation therapy (ADT) + Adenovirus/PSA VaccineExperimental Treatment1 Intervention
On Arm B, subjects will be started on androgen deprivation therapy (ADT) 14 days prior to beginning the vaccinations.
Group II: Adenovirus/PSA VaccineExperimental Treatment1 Intervention
On Arm A, subjects can begin the three vaccinations immediately.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Adenovirus/PSA Vaccine
2007
Completed Phase 2
~50

Find a Location

Who is running the clinical trial?

David M LubaroffLead Sponsor
1 Previous Clinical Trials
32 Total Patients Enrolled
United States Department of DefenseFED
873 Previous Clinical Trials
329,913 Total Patients Enrolled
39 Trials studying Prostate Cancer
9,232 Patients Enrolled for Prostate Cancer
David M Lubaroff, PhDPrincipal InvestigatorUniversity of Iowa
1 Previous Clinical Trials
32 Total Patients Enrolled
~3 spots leftby Jun 2025
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