Can a gene make prostate cancer cells soak up radiation?

NCT ID NCT00788307

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time

Summary

This phase 1 trial tests a gene therapy that helps prostate cancer cells absorb more radioactive iodine, potentially killing them while sparing healthy tissue. The study enrolls men whose prostate cancer returned after prior radiation therapy. Researchers aim to find the safest dose and evaluate side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a gene therapy (Ad5CMV-NIS) plus radioactive iodine (I-131) and liothyronine sodium
What this could lead to
If successful, this approach could offer a new treatment option for men with prostate cancer that returns after radiation therapy.
What could go wrong
This is an early phase 1 trial with only 8 participants, focused on safety and dosing. The treatment may not work or could cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

8 people

The number who actually took part.

Started

Nov 2008

Finished

Feb 2018

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 120 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

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