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

Study Identifier:
PrTK03
CT.gov Identifier:
NCT01436968
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Study Complete

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Study Summary

To evaluate ProstAtak’s ability to prevent prostate cancer recurrence in patients with newly diagnosed prostate cancer.

To determine if adjuvant therapy with an adenoviral vector (ProstAtak) improves the clinical outcome of radiation therapy for newly diagnosed prostate cancer.

To evaluate the effectiveness of ProstAtak immunotherapy in combination with radiation therapy for patients with intermediate-high risk localized prostate cancer.

To determine if adjuvant therapy with ProstAtak improves the clinical outcome of radiation therapy for newly diagnosed prostate cancer.

To evaluate the effectiveness of oncolytic viral immunotherapy using intra-tumoral administration of CAN-2409 followed by a valacyclovir prodrug

To evaluate the effectiveness and safety of CAN-2409 plus prodrug (valacyclovir) viral immunotherapy in combination with standard of care external beam radiation therapy to improve disease-free survival (DFS) in patients with intermediate-to-high risk, localized prostate cancer.

The objective of this study was to assess whether adding CAN-2409 in combination with the prodrug valacyclovir to standard of care radiation therapy could improve the proportion of patients achieving disease-free survival (DFS) among those pursuing curative treatment for newly diagnosed localized prostate cancer.

Blinded independent central pathologists assessed baseline and post-treatment prostate biopsies to evaluate biological response to treatment and determine proportion with pathologic complete response (pCR).

To improve disease-free survival (DFS) in localized PrCa patients (pts) treated with standard of care, leveraging the synergy between CAN-2409+prodrug and EBRT.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Prostate
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    III
    Sex
    Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: ProstAtak
    • Read More
  • Drug: 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.
  • Drug: Other Names:
  • Drug: Placebo Comparator: Control
  • Drug: The first injection will be given at least 15 days and not more than 8 weeks before starting radiation.
  • Drug: 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.
  • Drug: Patients were randomized and stratified for the use of short-term (< 6 months) androgen deprivation therapy (ADT).
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Study Complete

    Requirements information
    Inclusion criteria
    • 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
    • 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

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Carolinas
    Myrtle Beach, SC, United States, 29572
    Investigator
    Neal Shore
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Prostate