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.
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
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- 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.
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 group | Role | What they receive |
|---|---|---|
| Treatment (in situ gene therapy) | Experimental | 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. 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.
Number of toxicity incidents by NCI CTCAE v3.0 criteria
Measured: 3 years
Secondary outcomes (4)
Time to PSA progression
Measured: 3 years
Survival
Measured: 3 years
Incidence and duration of PSA response
Measured: 3 years
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.
- First posted10 Nov 2008 (estimated)
- Study start3 Nov 2008
- Primary completion7 Feb 2018
- Study completion7 Feb 2018
Why it stopped: closed early due to poor accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Brian J. Davis, M.D., Study chair, Mayo Clinic
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00788307
- Acronym / sponsor ID
- MC0252
- Conditions
- Prostate Cancer
- Keywords
- adenocarcinoma of the prostate, recurrent prostate cancer, stage I prostate cancer, stage II prostate cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: closed early due to poor accrual
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 3 Nov 2008 (actual)
- Primary completion
- 7 Feb 2018 (actual)
- Study completion
- 7 Feb 2018 (actual)
- First posted
- 10 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (in situ gene therapy) | Experimental | Biological: Ad5-CMV-NIS, Drug: Liothyronine Sodium, Genetic: Reverse Transcriptase Polymerase Chain Reaction, Other: laboratory biomarker analysis, Radiation: Iodine I 131, Radiation: Iodine I 123Patients 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. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ad5-CMV-NISAlso: recombinant type 5 adenovirus carrying the human NIS gene linked to the CMV promotorGiven intraprostatically | Biological | Treatment (in situ gene therapy) |
| Liothyronine SodiumAlso: Cytomel, TriostatGiven PO | Drug | Treatment (in situ gene therapy) |
| Reverse Transcriptase Polymerase Chain ReactionAlso: RT-PCR, reverse transcriptase-polymerase chain reactionPeripheral blood cells (20 ml of plasma collected in two CPT tubules) will be evaluated for evidence of virus DNA | Genetic | Treatment (in situ gene therapy) |
| laboratory biomarker analysisCorrelative study | Other | Treatment (in situ gene therapy) |
| Iodine I 131Also: 131I, iodine 131, I-131, Sodium Iodide I-131Given PO | Radiation | Treatment (in situ gene therapy) |
| Iodine I 123Also: I-123, iodine 123, 123I, Sodium Iodide I-123Given PO | Radiation | Treatment (in situ gene therapy) |
Primary outcome
Number of toxicity incidents by NCI CTCAE v3.0 criteria
Time frame: 3 years
4 secondary outcomes
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
Results and safety
The study was stopped early (reason given: closed early due to poor accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian J. Davis, M.D. study chair
Mayo Clinic
1 site in 1 country: see every site and its status.
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.