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A Randomized Controlled Trial of ProstAtak™ as Adjuvant to Up-front Radiation Therapy For Localized Prostate Cancer


Phase 3
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

A Randomized Controlled Trial of ProstAtak™ as Adjuvant to Up-front Radiation Therapy For Localized Prostate Cancer

Inclusion 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 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

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.

Outcome Time Frame:

Assessed at each visit every 6 months through year 5 until event occurs.

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

PrTK03

NCT ID:

NCT01436968

Start Date:

September 2011

Completion Date:

Related Keywords:

  • Prostate Cancer
  • immunotherapy, cytotoxicity, tumor vaccine, prostate cancer, radiotherapy
  • Prostatic Neoplasms

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
University of New Mexico Cancer CenterAlbuquerque, New Mexico  87131-5636
Arizona Oncology Services FoundationPhoenix, Arizona  85013
University of Massachusetts Medical SchoolWorcester, Massachusetts  01605
Walter Reed National Military Medical CenterBethesda, Maryland  20889
Genitourinary Surgical ConsultantsDenver, Colorado  80220
Advanced UrologyParker, Colorado  80134
The Johns Hopkins University School of Medicine, The Sidney Kimmel Comprehensive Cancer CenterBaltimore, Maryland  21231
Texas Urology SpecialistsTomball, Texas  77375
Foothills UrologyGolden, Colorado  80401
Dr. Ned Stein's OfficeHouston, Texas  77074
Dr. Irving Fishman's OfficeHouston, Texas  77030