Gene Therapy and Radioactive Iodine in Treating Patients With Locally Recurrent Prostate Cancer T… (NCT00788307) | Clinical Trial Compass
TerminatedPhase 1
Gene Therapy and Radioactive Iodine in Treating Patients With Locally Recurrent Prostate Cancer That Did Not Respond to Radiation Therapy
Stopped: closed early due to poor accrual
United States8 participantsStarted 2008-11-03
Plain-language 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.
Who can participate
Age range
18 Years – 120 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of toxicity incidents by NCI CTCAE v3.0 criteria