PrTK04 Ulysses Active Surveillance

The purpose of this study is to evaluate the effectiveness of ProstAtak® immunotherapy in patients undergoing active surveillance for localized prostate cancer. ProstAtak® involves the use of aglatimagene besadenovec (AdV-tk) to kill tumor cells and stimulate 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 been well tolerated in previous trials in patients with prostate cancer and other tumor types. Biochemical, pathologic and immune responses have been demonstrated in newly diagnosed and recurrent prostate cancer. 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 of care active surveillance evaluations.


Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: Male
Accepts Healthy Volunteers: No


Inclusion Criteria include:

  • Histologically confirmed adenocarcinoma of the prostate
  • Patients choosing active surveillance
  • Patients meeting definition of NCCN low risk, intermediate risk OR patients having only one NCCN high-risk feature
    • NCCN Low Risk is defined as having all of the following: PSA < 10 ng/ml, Gleason ≤ 6, T1-T2a
    • NCCN Intermediate Risk is defined as having at least one of the following and no high risk features: 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: High risk with more than 1 high risk factor; Locally advanced/very high risk=T3b-T4; Metastatic: N1 or M1
  • Patients must be planning and medically able to tolerate multiple transrectal ultrasound guided injections.
  • ECOG Performance status 0-2

Exclusion Criteria include:

  • Active liver disease, including known cirrhosis or active hepatitis
  • Patients on systemic corticosteroids (>10 mg prednisone per day) or other immunosuppressive drugs
  • Known HIV+ patients
  • Regional lymph node involvement or distant metastases
  • Other current malignancy (except squamous or basal cell skin cancers)
  • Other serious co-morbid illness or compromised organ function that, in the opinion of the investigator, would interfere with treatment or follow up
  • Prior treatment for prostate cancer except TURP. If prior TURP, patients must be deemed able to receive prostate biopsy and multiple intra-prostatic injections by the investigator
  • Patients taking 5-alpha-reductase inhibitors (e.g. finasteride, dutasteride)
  • Patients who had or plan to use ADT or have history of an orchiectomy.
  • Patients who are planning to undergo radical treatment for prostate cancer within 12 months.
  • Known sensitivity or allergic reactions to acyclovir or valacyclovir

Further study details as provided by Advantagene, Inc.:

Primary Outcome Measures:

  • Proactive surveillance score
    • Time Frame: 12 months

Secondary Outcome Measures:

  • Biochemical response (change in PSA)
    • Time Frame: Assessed at each visit at 3, 6, 9 and 12 months
  • Patient reported Health Related Quality of Life
    • Time Frame: Assessed at each visit at 3, 6, 9 and 12 months
  • Time to radical treatment
    • Time Frame: 5 years
  • The safety profile will be characterized by collection of adverse event information and laboratory values during the treatment phase.
    • Time Frame: Assessed at each visit at 3, 6, 9 and 12 months

Estimated Enrollment: 156
Study Start Date: May 2016
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)

Interested patients can schedule a consultation with Dr. Steven Sukin at 281-351-5174.