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 @ 5:19 PM
Ignite Modification Date:
2025-12-24 @ 5:19 PM
NCT ID:
NCT01420250
Eligibility Criteria:
Inclusion Criteria:
* Adenocarcinoma of the prostate with locally advanced prostate cancer without distant metastatic with unfavorable risk features that are defined below:
* Gleason score ≥8
* Gleason score 7 and T3/T4 disease
* Gleason score 7 but PSA ≥20
* Karnofsky Performance Status \>70,
* Age \> 18
* Performance Status: ECOG ≤2
* Peripheral neuropathy: must be \< grade 1
* Hematologic (minimal values):
* Absolute neutrophil count \> 1,500/mm3
* Hemoglobin \> 8.0 g/dl
* Platelet count \> 100,000/mm3
* Hepatic function
* Total bilirubin \< Upper limit of normal (ULN)(except for Gilbert's disease)
* AST (SGOT) \< 1.5 x ULN
* ALT (SGPT) \< 1.5 x ULN
* Creatinine \< 1.5 x ULN
* Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.
* No history of previous chemotherapy or pelvic irradiation
Exclusion Criteria:
* Patients with a history of severe hypersensitivity reaction to Cabazitaxel or other drugs formulated with polysorbate 80.
* History of urological surgery or procedures predisposing to GU complications after radiation (will be determined by radiation oncologist)
* History of diverticulitis, rectal bleeding or other lower GI diseases predisposing to GI complications after radiation (will be determined by radiation oncologist)
* History of prior chemotherapy or pelvic irradiation,
* History of prior invasive malignant cancer(s) within the last 5 years except adequately treated or controlled basal cell or squamous cell carcinoma of the skin
* Documented distant metastatic disease.
* Prior radical prostatectomy or cryosurgery for prostate cancer or bilateral orchiectomy
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT01420250
Study Brief:
Protocol Section:
NCT01420250