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

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Basic Trial Information

PhaseTypeAgeTrial IDs
Phase IIITreatment18 and overPrTK03
NCI-2012-01912, NCT01436968

Trial Description

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.

Eligibility Criteria

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 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

Exclusion 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

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

Advantagene Inc

    Trial Sites

    U.S.A.

    Maryland
    Baltimore

    Johns Hopkins University/Sidney Kimmel Cancer Center

    Theodore DeWeese
    Principal Investigator

    New Mexico
    Albuquerque

    University of New Mexico Cancer Center

    Thomas McNeil Schroeder
    Principal Investigator

    See All Trial Sites

    Link to the current ClinicalTrials.gov record.
    NLM Identifer NCT01436968

    Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.