Condition: Prostatic Neoplasms

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT01913106

Sponsor: The Methodist Hospital System

Phase: Phase 1/Phase 2

Eligibility:

• 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

View trial on ClinicalTrials.gov