Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
ProstAtak®
Patients randomized to the ProstAtak arm will receive two courses of aglatimagene besadenovec + valacyclovir
  • Biological: aglatimagene besadenovec
    Aglatimagene besadenovec will be delivered to the prostate via trans-rectal ultrasound guided injection followed by 14 days of oral prodrug, valacyclovir. The second aglatimagene besadenovec injection will be 2-3 weeks after the first followed by 14 days of valacyclovir.
    Other names:
    • AdV-tk
  • Drug: valacyclovir
    Oral prodrug to be given for 14 days starting the day after each aglatimagene besadenovec or placebo injection.
Placebo Comparator
Placebo
Patients randomized to the placebo arm will receive two corresponding courses of placebo + valacyclovir
  • Biological: placebo
    Placebo will be delivered to the prostate via trans-rectal ultrasound guided injection followed by 14 days of oral prodrug, valacyclovir. The second placebo injection will be 2-3 weeks after the first followed by 14 days of valacyclovir.
  • Drug: valacyclovir
    Oral prodrug to be given for 14 days starting the day after each aglatimagene besadenovec or placebo injection.

More Details

Status
Active, not recruiting
Sponsor
Advantagene, Inc.

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.