Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-24 @ 5:53 PM
NCT ID:
NCT00538668
Eligibility Criteria:
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 corticosteroids and/or adrenal hormone inhibitors within 4 weeks of treatment, except for low dose maintenance prednisone or hydrocortisone (i.e. for adrenal insufficienty) on a stable dose at the investigator's discretion
* Prior cytotoxic chemotherapy and/or radiation therapy within 4 weeks of treatment.
* Prior radiation therapy encompassing \>25% of expected red marrow distribution.
* Prior treatment with 89Strontium (Metastron®) or 153Samarium (Quadramet®)
* CNS metastasis
* History of seizure and/or stroke within past 6 months
* Known history of HIV
* Serum creatinine \> 2x ULN
* AST \> 2x ULN
* Bilirubin (total) \> 1.5x ULN; subjects with Gilbert's syndrome will be allowed if direct bilirubin is within institutional normal limits
* Serious active infection (as assessed by investigator)
* Active angina pectoris or NY Heart Association Class III-IV
* ECOG Performance Status \> 2
* Life expectancy \< 6 months
* Age \< 21 y.o
* Other serious illness(es) involving the cardiac, respiratory, CNS, renal, hepatic or hematological organ systems which might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study
* Prior treatment with monoclonal Ab J591 labeled with therapeutic doses of 177Lu or 90Y
* Other investigational therapy within 4 weeks of treatment
* Inability to understand and the willingness to sign a written informed consent document or to follow investigational procedures in the opinion of the investigator
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
21 Years
Maximum Age:
85 Years
Study:
NCT00538668
Study Brief:
Protocol Section:
NCT00538668