Phase I Trial of In Situ Gene Therapy for Locally Recurrent Prostate Cancer Following Radiation Therapy Failure Using Sodium/Iodide Symporter and Radioiodine
Inclusion Criteria
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