A Phase 1 interventional study of Ad5-CMV-NIS and Liothyronine Sodium in Prostate Cancer, sponsored by Mayo Clinic. Terminated at 1 site in United States. Open to male participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by Mayo Clinic · Phase 1, Interventional, and Treatment
RATIONALE: Radioactive drugs, such as radioactive iodine, may carry radiation directly to tumor cells and not harm normal cells. Placing a gene called Ad5CMV-NIS in prostate cancer cells may help the prostate cells take in more radioactive iodine and thus kill the cancer cells. Drugs, such as liothyronine sodium, may protect the thyroid from the side effects of radioactive iodine.
PURPOSE: This phase I trial is studying the side effects and best dose of gene therapy given together with radioactive iodine in treating patients with locally recurrent prostate cancer that did not respond to definitive radiation therapy.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation study of Ad5CMV-NIS.
Patients receive intraprostate Ad5CMV-NIS, via transperineal injection under anesthesia, on day 1. They receive dosimetry oral iodine I-123 on day 4 and undergo image studies periodically for the next 24 hours for measurement of radioiodine uptake. Patients with sufficient prostatic iodine I-123 uptake receive therapeutic oral iodine I-131 on days 5-7.
All patients with intact thyroid glands (i.e., not previously surgically removed or ablated) receive TSH suppressive doses of oral liothyronine sodium 3 times daily for 10 days prior and for 15 days post administration of iodine I-123.
Blood samples are collected periodically for measurement of PSA, fT4, and TSH; and peripheral blood cells are monitored for evidence of virus DNA via quantitative reverse-transcriptase-PCR.
After completion of study therapy, patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 10 years. A transrectal tumor biopsy is to be performed at 3 months and 1 year post-treatment.
6,367 studies on the registry are indexed under Prostatic Neoplasms; 1,397 are open to participants now.
This study's enrollment of 8 is below the median of 58 across 4,821 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
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DISEASE CHARACTERISTICS:
Histologically confirmed recurrent adenocarcinoma of the prostate within the past year
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)
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
PATIENT CHARACTERISTICS:
Willing to maintain a low-iodine diet for 12 days
No more than 1 of the following renal/genitourinary toxicities:
PRIOR CONCURRENT THERAPY:
Androgen-deprivation therapy (if applicable) initiated more than 3 months prior to registration
At least 2 weeks since prior and no concurrent exogenous corticosteroids
Patients receive intraprostatic Ad5CMV-NIS via transperineal injection on day 1. Patients also receive iodine I 123 PO QD on day 4. Patients with sufficient prostatic iodine I-123 uptake receive a single therapeutic oral dose of iodine I-131 on day 6 ±1 day. Patients with intact thyroid glands receive liothyronine sodium PO TID for 10 days prior and for 15 days following administration of iodine I-123.
Biological: Ad5-CMV-NIS · Drug: Liothyronine Sodium · Genetic: Reverse Transcriptase Polymerase Chain Reaction · Other: laboratory biomarker analysis · Radiation: Iodine I 131 · Radiation: Iodine I 123
Given intraprostatically
Also known as: recombinant type 5 adenovirus carrying the human NIS gene linked to the CMV promotor
Given PO
Also known as: Cytomel, Triostat
Peripheral blood cells (20 ml of plasma collected in two CPT tubules) will be evaluated for evidence of virus DNA
Also known as: RT-PCR, reverse transcriptase-polymerase chain reaction
Correlative study
Given PO
Also known as: 131I, iodine 131, I-131, Sodium Iodide I-131
Given PO
Also known as: I-123, iodine 123, 123I, Sodium Iodide I-123
Number of toxicity incidents by NCI CTCAE v3.0 criteria
Time frame: 3 years
Time to PSA progression
Time frame: 3 years
Survival
Time frame: 3 years
Incidence and duration of PSA response
Time frame: 3 years
Duration of PSA control
Time frame: 3 years
This study is terminated, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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