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 @ 11:14 PM
Ignite Modification Date:
2025-12-24 @ 11:14 PM
NCT ID:
NCT00669656
Eligibility Criteria:
Inclusion Criteria::
* Age greater than or equal to 18
* Histologically documented adenocarcinoma of the prostate
* Initial treatment with radical prostatectomy or external beam radiation
* Neoadjuvant/Adjuvant Androgen Deprivation therapy allowable, provided it was for a maximum of 24 months, with the last dose of medication at least 12 months previously
* Neoadjuvant or adjuvant chemotherapy allowable, provided it was for a maximum of 6 months, with the last dose of medication at least 12 months previously
* Adjuvant radiation after radical prostatectomy is allowed, provided at least 6 months have elapsed between completion of radiation and enrollment in study
* PSA recurrence, with a rising PSA, as defined by:
* Post Radiation Therapy:
* Absolute PSA \>2.0 ng/mL
* PSA nadir \<4 ng/mL after radiation
* Absolute rise of at least 0.5 ng/mL total
* At least 2 increases in PSA, separated by at least 2 weeks; these can be separated by a PSA value which declines provided the second rising value is higher than the first rising value.
* Post Prostatectomy:
* Absolute PSA \>1.0 ng/mL
* Absolute rise of at least 1 ng/mL total from nadir
* At least 2 increases in PSA separated by at least 2 weeks; these can be separated by a PSA value which declines provided the second rising value is higher than the first value
* PSA Doubling Time (PSA DT) more than 3 months and less than 36 months
* PSA DT to be calculated using the web-based calculator at http://kevin.phys.unm.edu/psa/ with the following constraints:
* At least 3 values, but no more than 6
* All values must be \>0.2
* Values must be separated by at least 2 months
* No radiographically evident bony or soft tissue metastases
* Documented discussion between subject and physician about the option to pursue hormone therapy and/or salvage local therapy rather than enroll in this study
* Patients who received treatment with androgen deprivation for biochemical recurrence are eligible provided:
* They did not document castration resistance (defined as 2 rising PSA values while testosteron \< 50
* They have been off androgen deprivation for at least 3 months and have recovered their testosterone (\>150)
* They have decided,in conjunction with their treating physician that they do not want to resume androgen deprivation
* ECOG Performance Status 0-2
* Life expectancy \> 12 months
* Adequate hepatic function (AST, ALT, bilirubin \<1.5 x ULN)
* Adequate renal function (eGFR by Cockcroft-Gault or comparable calculation \>50 ml/min)
* Willing to discontinue all nutritional supplements and 5-alpha reductase inhibitors (finasteride, dutasteride) for the duration of study treatment, unless the medication is being used to control symptoms of BPH and the patient has been taking the medication for more than 6 weeks
* Willing to discontinue all weight control medications for the duration of study treatment
* Signed informed consent
Exclusion Criteria:
* Atypical prostate carcinoma histology (ex: small cell, adenoid cystic)
* Evidence of bony or soft tissue metastatic disease on CT/MRI or bone scan or PET/CT
* Other invasive malignancy within prior 3 years, except for fully treated basal cell or squamous cell carcinoma of the skin.
* Full-dose anticoagulation therapy (warfarin or low molecular weight heparin) or antiplatelet therapy (clopidogrel or ticlopidine), with the exception of low-dose aspirin therapy (81 mg).
* Significant cardiac disease, included but not limited to angina, myocardial infarction, cardiomyopathy, congestive heart failure, and coronary artery disease which has required bypass surgery, angioplasty or stent placement.
* Significant uncontrolled comorbid condition which, in the opinion of the treating physician would compromise the subject's ability to comply with protocol requirements, or would pose undue risk for experiencing adverse events.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00669656
Study Brief:
Protocol Section:
NCT00669656