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Adenovirus/PSA Vaccine

Phase 2

Recurrent Prostate Cancer | Monoclonal antibody | Oncology |United Therapeutics Corporation|Last Updated: May 18, 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment50

FDA Designations

No designations recorded

Clinical trial landscape

Adenovirus/PSA Vaccine · 1 trial · 1 indication

Phase 2 1
NCT00583752Phase II Study of Adenovirus/PSA Vaccine in Men With Recurrent Prostate Cancer After Local Therapy APP21Recurrent Prostate Cancer
COMPLETED50 Analytics
PHASE2COMPLETED
Phase II Study of Adenovirus/PSA Vaccine in Men With Recurrent Prostate Cancer After Local Therapy APP21
Recurrent Prostate CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants Who Develop a Strong or Modest Anti-PSA Immune Response
18 months

Anti-immunologic response is defined as an increase of \>200% above pre-immunization levels of anti-PSA T cells as measured by ELISPOT analysis

Secondary Endpoints

Number of Participants With Stable, Decreased, or Increased PSA Doubling Times (PSADT)
18 months
Number of Participants Alive and Deceased Following Treatment
Every 6 months, up to 14 years
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Androgen deprivation therapy (ADT) + Adenovirus/PSA VaccineEXPERIMENTALOn Arm B, subjects will be started on androgen deprivation therapy (ADT) 14 days prior to beginning the vaccinations.
Adenovirus/PSA VaccineEXPERIMENTALOn Arm A, subjects can begin the three vaccinations immediately.

Interventions

NameTypeDescription
Adenovirus/PSA VaccineBIOLOGICAL1x10E8pfu in Gelfoam subcutaneously on day 0, 30, 60
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Eligibility Criteria

Age Range18 Years to 90 Years
SexMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Men with prostate cancer who have received prior local therapy (radical prostatectomy or definitive radiation therapy) and have biochemical (PSA) relapse without evidence of radiographic or clinical metastatic disease. * For men who had prior prostatectomy, the surgery must ha...

Countries:United States
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Competitive Landscape -Prostate Cancer 254 trials (matched to "Recurrent Prostate Cancer")

Frequently asked questions about Adenovirus/PSA Vaccine

What is Adenovirus/PSA Vaccine used for?

Adenovirus/PSA Vaccine is an investigational therapy being studied for the treatment of recurrent prostate cancer in men who have previously undergone local therapy. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

Who makes Adenovirus/PSA Vaccine?

Adenovirus/PSA Vaccine is being developed by United Therapeutics Corporation, a publicly traded company listed on the NASDAQ under the ticker symbol UTHR. The company is conducting clinical trials to evaluate the vaccine's safety and efficacy in patients with recurrent prostate cancer.

What phase is Adenovirus/PSA Vaccine in?

Adenovirus/PSA Vaccine is currently in Phase 2 clinical development. It is an investigational agent, meaning it has not yet received regulatory approval and is still being evaluated in clinical trials for the treatment of recurrent prostate cancer.

What clinical trials is Adenovirus/PSA Vaccine in?

Adenovirus/PSA Vaccine has been studied in one completed Phase 2 clinical trial registered as NCT00583752. This trial enrolled 50 male participants aged 18 years and older with recurrent prostate cancer in the United States and was a randomized, controlled study.

Is Adenovirus/PSA Vaccine a monoclonal antibody?

Adenovirus/PSA Vaccine is classified as a monoclonal antibody modality, although it is described as a vaccine in its clinical trial title. It is being investigated for its potential to treat recurrent prostate cancer by targeting prostate-specific antigen.