Ensayos clínicos

DISEASE CHARACTERISTICS:

• Histologically confirmed recurrent adenocarcinoma of the prostate within the past year
  • No transitional cell, small cell, or squamous cell carcinoma of the prostate
  • Local recurrence
• Disease recurred ≥ 18 months after completion of prior external beam radiotherapy (EBRT) for stage T1-T2b, N0/X, M0 disease
  • Biochemical failure as defined by the Phoenix definition (rise in PSA by 2 ng/mL or more above the nadir PSA)
    • PSA ≥ 0.3 ng/mL to < 20 ng/mL measured within the past 30 days
  • Pre-EBRT PSA < 50 ng/mL
  • Prior locally recurrent hormone-refractory disease allowed
• American Urologic Association Obstructive Symptom Index Score ≤ 24
• No known standard therapy that is potentially curative or definitely capable of extending life expectancy
• No evidence of or history of metastatic adenocarcinoma of the prostate
  • Negative radiographic metastatic work-up including whole-body radionuclide bone scan, CT and/or MR scan of the pelvis and abdomen, and chest x-ray
    • Patients with suspicious areas on conventional imaging studies are eligible provided they are biopsy negative
  • No known CNS metastases
• No prostate size > 140 cc

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2
• Life expectancy ≥ 12 weeks
• ANC ≥ 1,500/μL
• Platelet count ≥ 100,000/μL
• Hemoglobin ≥ 8.5 g/dL
• Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
• INR ≤ 1.4 times ULN
• Creatinine ≤ 1.5 times ULN
• Thyroid-stimulating hormone 0.3-5.0 uIU/mL and free thyroxine 0.8-1.87 ng/dL
• Willing to provide biologic specimens and participate in imaging studies as required
• Willing to maintain a low-iodine diet for 12 days
  • Starting 7 days prior to study virus injection continuing until after the iodine I 131 radioiodine therapy on day 5
• No more than 1 of the following renal/genitourinary toxicities:
  • Bladder spasms
  • Dysuria (painful urination)
  • Genitourinary fistula
  • Hemoglobinuria
  • Incontinence
  • Operative injury to bladder and/or ureter
  • Proteinuria
  • Renal failure
  • Uretal obstruction
  • Urinary frequency/urgency
  • Urinary retention
  • Urine color change (not related to other dietary or physiologic cause [e.g., bilirubin, concentrated urine, or hematuria])
  • Other renal/genitourinary toxicities
• No urinary tract infection within 72 hours prior to registration
• No pubic arch interference study demonstrating unacceptable prostate access by the transperineal approach
• No absence of rectum or other anatomic features that would preclude transperineal needle insertion into the prostate
• No coagulopathy that contraindicates transperineal and intraprostatic needle insertion
• No other cancer within the past 2 years, except for squamous cell and basal cell skin cancers
• No uncontrolled infection or fever > 100°F
• No known cardiac disease
• No seizure disorder
• No documented history of HIV positivity or other acquired immunodeficiency disorder or congenital immunodeficiency disorder

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• Recovered from acute, reversible effects of prior chemotherapy
• Androgen-deprivation therapy (if applicable) initiated more than 3 months prior to registration
  • Patients who have undergone bilateral orchiectomy are eligible if they meet all other criteria
• At least 6 weeks since prior bicalutamide, nilutamide, or oral or intravenous iodinated contrast
• At least 4 weeks since prior chemotherapy (6 weeks for mitomycin C or nitrosoureas), immunotherapy, biologic therapy, or other experimental drugs
• At least 4 weeks since prior and no concurrent anti-androgens (e.g., flutamide, estrogens, ketoconazole, PC-SPES, finasteride, or megestrol acetate)
• At least 2 weeks since prior and no concurrent exogenous corticosteroids
  • Patients clinically proven to require maintenance steroids allowed provided there has been no change in their dose within the past 6 weeks
• No antibiotic therapy within the past 72 hours
• No prior organ transplantation
• No prior salvage prostatectomy or brachytherapy
• No other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational
• No concurrent prophylactic use of colony-stimulating factors
• No concurrent enrollment in any other study involving a pharmacologic agent (drugs, biologics, immunotherapy approaches, gene therapy) whether for symptom control or therapeutic intent