Phase I-II Study HSV-tk + Valacyclovir Therapy in Combination With Brachytherapy for Recurrent Prostate Cancer With or Without Metastatic Disease

Condition: Prostatic Neoplasms

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT01913106

Sponsor: The Methodist Hospital System

Phase: Phase 1/Phase 2


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

Inclusion Criteria:

  • biopsy-proven local recurrence of prostate cancer without metastatic disease after the hormone therapy at least 2 year after the completion of definitive radiation therapy
  • Zubrod performance status 0-1
  • WBC ≥ 4,000/μl, platelets ≥ 100,000/μl
  • hemoglobin ≥ 8.5 mg/dl
  • normal partial thromboplastin time and prothrombin time
  • bilirubin < 1.5 mg/dl, and AST and alanine aminotransferase < 2.5 times the upper limit of normal
  • Serum creatinine ≤ 1.6 mg/dl
  • Must undergo pre-treatment evaluation of tumor extent and tumor measurement
  • Nutritional and general physical condition must be considered compatible with the proposed radio-therapeutic treatment
  • Not on any other experimental therapeutic cancer treatment
  • No active untreated infection
  • No major medical or psychiatric illness
  • International Prostate Symptom Score (IPSS) less than 15
  • Signed study-specific consent form prior to study entry
  • Prostate volume less than 50 cc
  • PSA > 10ng/ml within the past 3 months may enter study

Exclusion Criteria:

  • Symptomatic metastasis disease
  • Patients with a life expectancy < 10 years
  • Patients on corticosteroids or any immunosuppressive drugs.
  • HIV + patients
  • Patients with acute infections (viral, bacterial, or fungal infections requiring therapy)
  • Patients with cirrhosis.
  • Patients with collagen vascular diseases
  • International Prostate Symptom Score (IPSS) greater than 15
  • Prostate volume greater than 50 cc
  • Second active cancer except cutaneous cancer
  • Patients with history of allergies to valacyclovir, acyclovier or who cannot take oral pills

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