Prostvac in Patients With Biochemically Recurrent Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Background:

      Some people who have been treated for prostate cancer still have high prostate-specific
      antigen (PSA) levels. This may indicate cancer. These people have non-metastatic castration
      sensitive prostate cancer (nmCSPC) or biochemical recurrent prostate cancer. Researchers
      think the immune system can be taught to fight and kill cancer cells. They think an
      immunotherapy vaccine called prostvac could help reduce PSA levels in people with this type
      of prostate cancer.

      Objective:

      To test if prostvac can decrease tumor growth rate as measured by PSA compared to getting
      surveillance alone.

      Eligibility:

      Men ages 18 or older who have nmCSPC or biochemical recurrent prostate cancer

      Design:

      Participants will be screened with:

      Medical history

      Physical exam

      Blood and urine tests

      Bone scan

      Computed tomography (CT) scan, or magnetic resonance imaging (MRI) and positron emission
      tomography (PET) scan: They lie in a machine that takes pictures of the body.

      Electrocardiogram: Soft electrodes are stuck to the skin to record heart signals.

      Participants will be part of 1 of 2 arms: Arm A will get prostvac for 6 months. Arm B will
      have surveillance for 6 months followed by prostvac for 6 months.

      During the prostvac period, participants will get prostvac as a shot under the skin on weeks
      1, 3, and 5, and then monthly for a total of 5 months.

      Participants will have follow-up visits at least every month until they recover from prostvac
      side effects or their cancer worsens. Visits may include repeats of screening tests.

      Participants will be followed for up to 15 years. They will have a physical exam every year
      for the first 5 years. They will have phone calls once a year.
    

Detailed description: 
      BACKGROUND

        -  Androgen deprivation therapy (ADT) and surveillance are treatment options for prostate
           cancer patients with biochemical progression after localized therapy (biochemically
           recurrent prostate cancer). The primary goal in these patients is to prevent morbidity
           from their cancer and to do so with limited toxicity.

        -  Prostvac (Prostvac; developed by the National Cancer Institute [NCI] and licensed to BN
           Immunotherapeutics, Mountain View, CA) is a novel candidate prostate cancer
           immunotherapy for the treatment of prostate cancer. It is a viral vector based
           therapeutic cancer vaccine that is administered via subcutaneous injections. In a
           randomized controlled Phase 2 trial, Prostvac therapy was associated with a prolongation
           of survival in men with metastatic castrate-resistant prostate cancer. A phase III trial
           recently completed accrual of patients in this same population.

        -  There is also rationale to use therapeutic cancer vaccines such as Prostvac in earlier
           stage prostate cancer patients to maximize the potential therapeutic effect of immune
           stimulating therapy.

        -  Analysis of previous trials using therapeutic cancer vaccines alone suggests that such
           therapies may alter tumor growth rate.

      OBJECTIVE

      Primary Objective:

      -Determine if the therapeutic cancer vaccine prostvac can decrease tumor growth rate as
      measured by prostate-specific antigen (PSA) rise after 6 months compared to a group getting
      surveillance alone.

      KEY ELIGIBILITY CRITERIA

        -  Histologically confirmed adenocarcinoma of the prostate

        -  Patients with negative computed tomography (CT) Scan and Tc-99m Bone Scan

        -  Patients with a PSA over 0.8 ng/ml for patients following radical prostatectomy or for
           patients following definitive radiation therapy: a rise in PSA of greater than or equal
           to 2 ng/mL above the nadir

        -  Patients with a PSA doubling time of 5-15 months

        -  No history of active autoimmune disease or history of organ compromising autoimmune
           disease

        -  Eastern Cooperative Oncology Group (ECOG) 0 -1

      DESIGN

        -  Randomized study

        -  Accrual goal is 36 evaluable patients per arm; randomized 1:1 to:

             -  Arm A: Prostvac for 6 months with an additional optional year of maintenance for
                eligible patients OR

             -  Arm B: Surveillance for 6 months, then Prostvac for 6 months with an additional
                year of maintenance for eligible patients
    

Intervention name(s): PROSTVAC -V; PROSTVAC-F
Intervention type(s): Biological; Biological
Intervention description(s): Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus; Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Vaccine; PSA; Surveillance; Immunotherapy