Clinical Trials /

Phase 3 Study of ProstAtak® Immunotherapy With Standard Radiation Therapy for Localized Prostate Cancer

NCT01436968

Description:

The purpose of this study is to evaluate the effectiveness of ProstAtak® immunotherapy in combination with radiation therapy for patients with intermediate-high risk localized prostate cancer. ProstAtak kills tumor cells and stimulates a cancer vaccine effect. Killing tumor cells in an immune stimulatory environment induces the body's immune system to detect and destroy cancer cells. ProstAtak has shown synergy with radiation without added toxicity and lower than expected recurrence rates in previous clinical trials. The hypothesis is that ProstAtak can lead to improvement in the clinical outcome for patients with prostate cancer. Participants will be randomized to the ProstAtak or control arm at a 2:1 ratio. Both arms receive standard external beam radiation therapy. Short-term androgen deprivation therapy may be given but is not required.

Related Conditions:
  • Prostate Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Phase 3 Study of ProstAtak® Immunotherapy With Standard Radiation Therapy for Localized Prostate Cancer
  • Official Title: A Randomized Controlled Trial of ProstAtak® as Adjuvant to Up-front Radiation Therapy For Localized Prostate Cancer

Clinical Trial IDs

  • ORG STUDY ID: PrTK03
  • NCT ID: NCT01436968

Conditions

  • Prostate Cancer

Interventions

DrugSynonymsArms
ProstAtak®(AdV-tk) + valacyclovirProstAtak®
Placebo + valacyclovirControl

Purpose

The purpose of this study is to evaluate the effectiveness of ProstAtak® immunotherapy in combination with radiation therapy for patients with intermediate-high risk localized prostate cancer. ProstAtak kills tumor cells and stimulates a cancer vaccine effect. Killing tumor cells in an immune stimulatory environment induces the body's immune system to detect and destroy cancer cells. ProstAtak has shown synergy with radiation without added toxicity and lower than expected recurrence rates in previous clinical trials. The hypothesis is that ProstAtak can lead to improvement in the clinical outcome for patients with prostate cancer. Participants will be randomized to the ProstAtak or control arm at a 2:1 ratio. Both arms receive standard external beam radiation therapy. Short-term androgen deprivation therapy may be given but is not required.

Trial Arms

NameTypeDescriptionInterventions
ProstAtak®ExperimentalProstAtak® (AdV-tk) + valacyclovir + radiation therapy +/- ADT
    ControlPlacebo ComparatorPlacebo + valacyclovir + radiation therapy +/- ADT

      Eligibility Criteria

              Inclusion Criteria include:
      
                -  Localized prostate cancer meeting the NCCN criteria of Intermediate Risk or patients
                   having only one NCCN high-risk feature
      
                     -  NCCN Intermediate Risk is defined as having at least one of the following: PSA
                        10-20 ng/ml, Gleason score =7, T2b-T2c
      
                     -  High Risk with a single high risk feature is defined as having only one of the
                        following: PSA>20 ng/ml, Gleason score 8-10, or T3a
      
                     -  Excluded are those in the following risk groups: Low risk; High risk with more
                        than 1 high risk factor; Locally advanced/very high risk=T3b-T4; Metastatic: N1
                        or M1
      
                -  Planning to undergo standard prostate-only external beam radiation therapy
      
                -  ECOG Performance Status 0-2
      
              Exclusion Criteria include:
      
                -  Liver disease, including known cirrhosis or active hepatitis
      
                -  Patients on systemic corticosteroids (>10mg prednisone per day) or other
                   immunosuppressive drugs
      
                -  Known HIV+ patients
      
                -  Regional lymph node involvement or distant metastases
      
                -  Patients planning to receive whole pelvic irradiation
      
                -  Prior treatment for prostate cancer, except TURP or ADT. For ADT, it may only be
                   given for a maximum of 6 months
      
                -  Patients who had or plan to have orchiectomy as the form of hormonal ablation
      
                -  Known sensitivity or allergic reactions to acyclovir or valacyclovir
            
      Maximum Eligible Age:N/A
      Minimum Eligible Age:18 Years
      Eligible Gender:Male
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure:Disease free survival defined as the time from randomization until the date of the first failure event will be compared for the ProstAtak® arm versus the placebo control arm. The analyses will be based on the intent to treat population.
      Time Frame:Assessed at each visit every 6 months through year 5 until event occurs.
      Safety Issue:
      Description:

      Secondary Outcome Measures

      Measure:Prostate cancer specific survival and overall survival will be compared for the ProstAtak® arm versus the placebo control arm.
      Time Frame:Assessed at each visit every 6 months through year 5 after which long-term follow up of general health status will continue yearly.
      Safety Issue:
      Description:
      Measure:PSA nadir will be compared for the ProstAtak® arm versus the placebo control arm.
      Time Frame:Assessed at each visit every 6 months through year 5.
      Safety Issue:
      Description:
      Measure:Patient reported Health Related Quality of Life outcomes will be collected using the Expanded Prostate Cancer Index Composite (EPIC-26) questionnaire. The change in QOL over time will be compared for the ProstAtak® arm versus the placebo control arm.
      Time Frame:Assessed at baseline and at 3, 6, 12, 18 and 24 months after completion of radiation.
      Safety Issue:
      Description:
      Measure:The safety profile will be characterized by collection of adverse event information and laboratory values during the treatment phase (until the completion of radiation). Data on late effects will be collected after radiation completion.
      Time Frame:Assessed at each visit and continuously throughout the study.
      Safety Issue:
      Description:

      Details

      Phase:Phase 3
      Primary Purpose:Interventional
      Overall Status:Recruiting
      Lead Sponsor:Advantagene, Inc.

      Trial Keywords

      • immunotherapy, cytotoxicity, tumor vaccine, prostate cancer, radiotherapy

      Last Updated

      April 17, 2017