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Prostate CancerPhase 1NCT00788307

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

A Phase 1 study testing Ad5-CMV-NIS, Liothyronine Sodium and Reverse Transcriptase Polymerase Chain Reaction in people with Prostate Cancer, run by Mayo Clinic at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 120 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Ad5-CMV-NIS, Liothyronine Sodium and Reverse Transcriptase Polymerase Chain Reaction
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteUnited States
Study dates
3 Nov 2008to 7 Feb 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

About this study

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

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.

Conditions
Prostate Cancer
Being tested
Ad5-CMV-NIS, Liothyronine Sodium, Reverse Transcriptase Polymerase Chain Reaction, laboratory biomarker analysis, Iodine I 131
Keywords
adenocarcinoma of the prostate, recurrent prostate cancer, stage I prostate cancer, stage II prostate cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ad5-CMV-NISBiological

    Also called recombinant type 5 adenovirus carrying the human NIS gene linked to the CMV promotor

    Given intraprostatically

  • Liothyronine SodiumDrug

    Also called Cytomel, Triostat

    Given PO

  • Reverse Transcriptase Polymerase Chain ReactionGenetic

    Also called RT-PCR, reverse transcriptase-polymerase chain reaction

    Peripheral blood cells (20 ml of plasma collected in two CPT tubules) will be evaluated for evidence of virus DNA

  • laboratory biomarker analysisOther

    Correlative study

  • Iodine I 131Radiation

    Also called 131I, iodine 131, I-131, Sodium Iodide I-131

    Given PO

  • Iodine I 123Radiation

    Also called I-123, iodine 123, 123I, Sodium Iodide I-123

    Given PO

Study groups in NCT00788307
Study groupRoleWhat they receive
Treatment (in situ gene therapy)ExperimentalPatients 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.
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 3 years

Secondary outcomes (4)
  1. Time to PSA progression

    Measured: 3 years

  2. Survival

    Measured: 3 years

  3. Incidence and duration of PSA response

    Measured: 3 years

  4. Duration of PSA control

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Nov 2008 (estimated)
  2. Study start3 Nov 2008
  3. Primary completion7 Feb 2018
  4. Study completion7 Feb 2018

Why it stopped: closed early due to poor accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00788307
Sponsor's protocol ID
MC0252
Other IDs
P50CA091956, 06-009392
Status last verified
Jul 2026
First submitted
7 Nov 2008
Last updated
22 Jul 2026
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ad5-CMV-NIS, Liothyronine Sodium and Reverse Transcriptase Polymerase Chain Reaction in people with Prostate Cancer, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: closed early due to poor accrual). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of toxicity incidents by NCI CTCAE v3.0 criteria (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.

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