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

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ClinicalTrials.gov Identifier: NCT01436968
Recruitment Status : Recruiting
First Posted : September 20, 2011
Last Update Posted : July 24, 2018
Sponsor:
Information provided by (Responsible Party):
Advantagene, Inc.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Biological: ProstAtak®(AdV-tk) + valacyclovir Biological: Placebo + valacyclovir Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 711 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of ProstAtak® as Adjuvant to Up-front Radiation Therapy For Localized Prostate Cancer
Study Start Date : September 2011
Estimated Primary Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: ProstAtak®
ProstAtak® (AdV-tk) + valacyclovir + radiation therapy +/- ADT
 Biological: ProstAtak®(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.
Placebo Comparator: Control
Placebo + valacyclovir + radiation therapy +/- ADT
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. 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. ]
  2. 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. ]
  3. 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. ]
  4. 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. ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01436968


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Sponsors and Collaborators
Advantagene, Inc.
More Information
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Responsible Party: Advantagene, Inc.
ClinicalTrials.gov Identifier: NCT01436968     History of Changes
Other Study ID Numbers: PrTK03
First Posted: September 20, 2011    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018

Keywords provided by Advantagene, Inc.:
immunotherapy, cytotoxicity, tumor vaccine, prostate cancer, radiotherapy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
 Prostatic Diseases
Valacyclovir
Acyclovir
Antiviral Agents
Anti-Infective Agents