Approval Probability
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Adjusted LOA
ML Risk
Adenovirus/PSA Vaccine · 1 trial · 1 indication
Anti-immunologic response is defined as an increase of \>200% above pre-immunization levels of anti-PSA T cells as measured by ELISPOT analysis
| Arm | Type | Description |
|---|---|---|
| Androgen deprivation therapy (ADT) + Adenovirus/PSA Vaccine | EXPERIMENTAL | On Arm B, subjects will be started on androgen deprivation therapy (ADT) 14 days prior to beginning the vaccinations. |
| Adenovirus/PSA Vaccine | EXPERIMENTAL | On Arm A, subjects can begin the three vaccinations immediately. |
| Name | Type | Description |
|---|---|---|
| Adenovirus/PSA Vaccine | BIOLOGICAL | 1x10E8pfu in Gelfoam subcutaneously on day 0, 30, 60 |
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...
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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.
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.
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.
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.
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.