Radioimmunotherapy in Prostate Cancer Using 177Lu-J591 Antibody (NCT00538668) | Clinical Trial Compass
CompletedPhase 1
Radioimmunotherapy in Prostate Cancer Using 177Lu-J591 Antibody
United States55 participantsStarted 2007-08
Plain-language summary
The purpose of this study is to test the safety of the experimental drug, 177Lu-J591 and see what effects (good and bad) it has on your prostate cancer. Another purpose is to find the highest dose of the drug that can be given without causing severe side effects.
Who can participate
Age range
21 Years – 85 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.
Inclusion Criteria
* Histologic diagnosis (recent or remote) of prostate adenocarcinoma
* Progressive, castrate metastatic carcinoma of the prostate defined by presence of metastatic disease on imaging and:
* progressive tumor lesions on CT or MRI and/or
* new osseus lesions on bone scan and/or
* rising PSA
* Rising PSA on 3 serial determinations over a period of greater than 2 weeks. An increase in PSA must be determined by two separate measurements taken at least one week apart and confirmed by a third and if necessary, a fourth measurement. If the third measurement is not greater than the second, then a fourth measurement must be taken. The fourth measurement must be greater than the second measurement for the patients to be eligible for enrollment in the study. The minimum final PSA must be \> 2.
* For subjects who have not undergone surgical orchiectomy, LHRH agonist or antagonist therapy must me maintained for the duration of this study
* Platelet count \> 150,000/mm3
* Absolute neutrophil count (ANC) ≥ 2,000/mm3
* Normal coagulation profile (defined as PT or INR and PTT \< 1.3x ULN), unless on a stable anticoagulation regimen
* Hematocrit \> 27% or Hemoglobin \> 9 g/dL without blood transfusion dependency
* Patients of child bearing potential must agree to use an effective method of contraception
* Patient must have progressed following discontinuation of anti-androgen therapy, if received
* Serum testosterone \< 50 ng/ml
Exclusion Criteria
* Prior corti…
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
Define the PK and dosimetry of 177Lu-J591
Timeframe: Perform imaging and pharmacokinetic (PK) sampling during the first two weeks of treatment.
2
Determine the cumulative maximum tolerated dose of 177Lu-J591 in a 2 week dose-fractionation regimen.
Timeframe: Will be determined baesd on toxicity experienced by patients at each dose level.
3
Determine the myelotoxicity of fractionated dose of 177Lu-J591
Timeframe: Lab tests will be performed weekly.
4
Define the preliminary efficacy (response rate) of 177Lu-J591
Timeframe: PSA will be evaluated at baseline and weeks 6, 10 and 14. Scan will be perfoemed at baseline and week 14.
Trial details
NCT IDNCT00538668
SponsorWeill Medical College of Cornell University