Phase 3 Study of ProstAtak™ With Standard Radiation Therapy for Localized Prostate Cancer (PrTK03)

This study is currently recruiting participants.
Verified February 2014 by Advantagene, Inc.
Sponsor:
Information provided by (Responsible Party):
Advantagene, Inc.
ClinicalTrials.gov Identifier:
NCT01436968
First received: September 19, 2011
Last updated: February 12, 2014
Last verified: February 2014

September 19, 2011
February 12, 2014
September 2011
September 2015   (final data collection date for primary outcome 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. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01436968 on ClinicalTrials.gov Archive Site
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Phase 3 Study of ProstAtak™ With Standard Radiation Therapy for Localized Prostate Cancer
A Randomized Controlled Trial of ProstAtak™ as Adjuvant to Up-front Radiation Therapy For Localized Prostate Cancer

This is a double-blinded, randomized, placebo-controlled Phase 3 trial of ProstAtak™(AdV-tk + valacyclovir) in combination with standard external beam radiation therapy with or without androgen deprivation therapy (ADT) for intermediate-high risk localized prostate cancer. ProstAtak™ is an investigational product that kills tumor cells and elicits an anti-tumor vaccine effect. The hypothesis is that this combination therapy can lead to improvement in the clinical outcome for patients with newly diagnosed prostate cancer. Patients will be randomized to the ProstAtak™ or control arm at a 2:1 ratio.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Prostate Cancer
  • Biological: AdV-tk + valacyclovir

    Patients will receive three courses of ProstAtak™ each consisting of AdV-tk injection + oral valacyclovir. AdV-tk injection will be delivered to the prostate via trans-rectal ultrasound guided injection as follows:

    1. The first injection will be given at least 15 days and not more than 8 weeks before starting radiation.
    2. The second injection will be 0-3 days before initiation of radiation therapy.
    3. The third injection will be 15-22 days after the 2nd injection.

    The prodrug, valacyclovir, will be administered at a fixed dose for 14 days after each AdV-tk injection.

    Standard external beam radiation therapy will be delivered to the prostate. Short-term androgen deprivation therapy (maximum of 6 months) is optional but must be decided before enrollment to allow for stratification.

  • Biological: Placebo + valacyclovir

    Patients will receive three courses each consisting of placebo injection + oral valacyclovir. Placebo injection will be delivered to the prostate via trans-rectal ultrasound guided injection as follows:

    1. The first injection will be given at least 15 days and not more than 8 weeks before starting radiation.
    2. The second injection will be 0-3 days before initiation of radiation therapy.
    3. The third injection will be 15-22 days after the 2nd injection.

    The prodrug, valacyclovir, will be administered at a fixed dose for 14 days after each placebo injection.

    Standard external beam radiation therapy will be delivered to the prostate. Short-term androgen deprivation therapy (maximum of 6 months) is optional but must be decided before enrollment to allow for stratification.

  • Experimental: ProstAtak™
    AdV-tk + valacyclovir + radiation therapy +/- ADT
    Intervention: Biological: AdV-tk + valacyclovir
  • Placebo Comparator: Control
    Placebo + valacyclovir + radiation therapy +/- ADT
    Intervention: Biological: Placebo + valacyclovir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
711
Not Provided
September 2015   (final data collection date for primary outcome measure)

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 corticosteroids 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 started < 2 months before first planned AdV-tk or placebo injection and 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
Male
18 Years and older
No
Not Provided
United States
 
NCT01436968
PrTK03
Yes
Advantagene, Inc.
Advantagene, Inc.
Not Provided
Not Provided
Advantagene, Inc.
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP