Can a gene make prostate cancer cells soak up radiation?
NCT ID NCT00788307
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
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8 people
The number who actually took part.
- Started
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Nov 2008
- Finished
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Feb 2018
- Lead sponsor
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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
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18 to 120 years
- Sex
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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 Hide 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
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Mayo Clinic
Rochester, Minnesota, 55905, United States
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