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 @ 3:50 PM
Ignite Modification Date:
2025-12-24 @ 3:50 PM
NCT ID:
NCT01558492
Eligibility Criteria:
Inclusion Criteria:
* Histologic or cytologic diagnosis of prostate carcinoma.
* Subject must have progressive metastatic prostate cancer despite adequate medical or surgical castration therapy. Furthermore, if applicable, medical castration must be maintained for the duration of the protocol.
* Serum testosterone \< 50 ng/ml.
* Subjects who have received anti-androgen therapy with a resulting PSA decline must demonstrate progression following discontinuation of anti-androgen therapy.
* Subjects capable of fathering children must agree to use an effective method of contraception for the duration of the trial.
* Must have previously received docetaxel for prostate cancer
* ECOG performance status 0-2
* Willing and able to give informed consent
Exclusion Criteria:
* Platelet count \<100,000/mm3
* Absolute neutrophil count (ANC) \<1,500/mm3
* Hemoglobin \< 8 g/dL
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2.5 x upper limit of normal
* Bilirubin (total) \>2 x upper limit of normal. Subjects with known Gilbert's syndrome are eligible if direct bilirubin is within normal limits
* For subjects with serum creatinine \> 1.5 x ULN, calculated creatinine clearance \< 30 ml/min are excluded; subjects meeting this exclusion criterion are eligible if a measured clearance is \> 30 ml/min
* 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 investigational therapy within 4 weeks of treatment. Furthermore, other investigational anti-cancer therapy is not permitted during the treatment phase.
* Grade \> 1 peripheral neuropathy
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT01558492
Study Brief:
Protocol Section:
NCT01558492