Gene Therapy and Radioactive Iodine in Treating Patients With Locally Recurrent Prostate Cancer That Did Not Respond to Radiation Therapy

You may be eligible if

• 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 or brachytherapy for stage T1-T3, 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-treatment 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 μIU/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 study 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
• 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
• 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