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 @ 4:02 PM
Ignite Modification Date:
2025-12-24 @ 4:02 PM
NCT ID:
NCT00764166
Eligibility Criteria:
Inclusion Criteria:
* Histologically documented adenocarcinoma of the prostate
* Previous treatment with either radical prostatectomy or radiation therapy
* Salvage radiotherapy for local relapse allowed
* Neoadjuvant or per radiotherapy Hormonal therapy allowed in case of more than 6 months free-interval before first rising PSA
* Life expectancy of more than 12 months
* Non metastatic disease documented by imaging including radionuclide bone scan
* ECOG performance status 0-1
* ANC \> 1,500/mm3
* Platelet counts \> 100,000/mm3
* SGOT and/or SGPT may be up to 2.5 x ULN
Patients at high risk of biological relapse defined by:
* Gleason \> 8
* PSA-DT \< 6 months
* Positive surgical margins
* PSA velocity \> 0.75 ng/mL/year
* Pathological pelvic lymph nodes involvement (pN+)
* Time from initial treatment until inclusion \< 12 months
Exclusion Criteria:
* Prior chemotherapy by taxanes and estramustine phosphate
* Documented local recurrence of prostate cancer or documented metastatic disease
* History of other malignancy within the last 5 years other than curatively treated basal cell carcinoma of the skin
* Active infection
* Significant cardiac disease, angina pectoris or myocardial infarction within twelve months
* Clinically significant neuropathy
* Medical condition requiring the use of concomitant corticosteroids
* Prohibited concomitant therapy with experimental drug.
* Participation in another clinical trial for the period \< 30 days
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00764166
Study Brief:
Protocol Section:
NCT00764166