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TerminatedNCT00788307Updated Jul 22, 2026

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

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

Why this study was terminated
closed early due to poor accrual
Phase
Phase 1
Study type
Interventional
Enrollment
8
Allocation
Not applicable
Ages
18 Years to 120 Years
Sex
Male
01

Study summary

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.

Read the detailed description

OBJECTIVES:

Primary

  • To determine the safety and tolerance of Ad5CMV-NIS administered intraprostatically followed by radioiodine treatment in patients with locally recurrent adenocarcinoma of the prostate following radiotherapy.
  • To determine the maximum tolerated dose of Ad5CMV-NIS in these patients.

Secondary

  • To evaluate the PSA response rates, duration, and time to PSA progression in these patients.

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.

02

Conditions studied

  • Prostate Cancer

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Keywords

  • adenocarcinoma of the prostate
  • recurrent prostate cancer
  • stage I prostate cancer
  • stage II prostate cancer
03

In context

Prostatic Neoplasms

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 →

Lead sponsor

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.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Eligibility 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 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

    • 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
  • 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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (actual)

Study arms

  • Experimental
    Treatment (in situ gene therapy)

    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

Interventions

  • BiologicalAd5-CMV-NIS

    Given intraprostatically

    Also known as: recombinant type 5 adenovirus carrying the human NIS gene linked to the CMV promotor

  • DrugLiothyronine Sodium

    Given PO

    Also known as: Cytomel, Triostat

  • GeneticReverse Transcriptase Polymerase Chain Reaction

    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

  • Otherlaboratory biomarker analysis

    Correlative study

  • RadiationIodine I 131

    Given PO

    Also known as: 131I, iodine 131, I-131, Sodium Iodide I-131

  • RadiationIodine I 123

    Given PO

    Also known as: I-123, iodine 123, 123I, Sodium Iodide I-123

06

What researchers measure

Primary outcomes

  1. Number of toxicity incidents by NCI CTCAE v3.0 criteria

    Time frame: 3 years

Secondary outcomes

  1. Time to PSA progression

    Time frame: 3 years

  2. Survival

    Time frame: 3 years

  3. Incidence and duration of PSA response

    Time frame: 3 years

  4. Duration of PSA control

    Time frame: 3 years

07

Study locations

1 site
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00788307
Lead sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Nov 10, 2008
Start date
Nov 3, 2008
Primary completion
Feb 7, 2018
Completion
Feb 7, 2018
Last update
Jul 22, 2026

Study contacts

Brian J. Davis, M.D.
study chair · Mayo Clinic

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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