A Randomized Controlled Trial Of AdV-tk + Valacyclovir Administered During Active Surveillance For Newly Diagnosed Prostate Cancer


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02768363

Sponsor: Advantagene, Inc.

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

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

View trial on ClinicalTrials.gov