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 @ 9:10 PM
Ignite Modification Date:
2025-12-24 @ 9:10 PM
NCT ID:
NCT00039104
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed (adeno)carcinoma of the prostate refractory to hormone therapy
* Metastatic bone disease, as documented by bone scan and confirmed by x-rays, CT scan or MRI scan
* Note: Patients may also have measurable disease in the lymph nodes (retroperitoneal, pelvic or inguinal only), prostate and /or prostatic bed; measurable disease is defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 20 mm =\< 21 days prior to registration
* PSA progression defined as two consecutive increases in PSA value over the previous reference value; the first increase of PSA should occur no earlier than one (1) week after the reference measurement; all patients need to demonstrate continued PSA elevation with an increasing PSA four weeks after the required cessation of their antiandrogen treatment; the required cessation period is 4 weeks for flutamide, nilutamide, and Megace-based treatment, and 8 weeks for bicalutamide-based treatment
* One of the following:
* Continuing primary androgen suppression (LHRH agonist)
* Orchiectomy
* WBC \>= 2000/mm\^3
* Absolute neutrophil count (ANC) \>= 1500/mm\^3
* PLT \>= 100,000/mm\^3
* Hgb \>= 9.0 g/dL
* Total bilirubin =\< institutional upper normal limits (UNL)
* AST =\< 1.5 x UNL
* Serum creatinine =\< 1.5 x UNL
* PSA \>= 5 ng/mL
* Serum testosterone \< 50 ng/dL =\< 3 months prior to registration
* Estimated life expectancy of \>= 6 months
* ECOG Performance Status (PS) 0, 1, or 2
* Capable of understanding the investigational nature, potential risks and benefits of the study and able to provide valid informed consent
* If sexually active, willing to use an accepted and effective method of contraception consistently for the duration of study participation
Exclusion Criteria:
* Any of the following:
* \> 2 prior chemotherapy regimen
* \> 2 non-hormonal treatments for metastatic disease (including biologics, gene therapy, angiogenesis inhibitors, etc., but excluding external radiotherapy)
* Prior therapy with a matrix metalloproteinase inhibitor (MMPI)
* Immunotherapy =\< 4 weeks prior to study entry
* Biologic therapy =\< 4 weeks prior to study entry
* Radiation therapy =\< 4 weeks prior to study entry
* Concomitant hormonal treatment (except LHRH)
* Prior use of systemic radiopharmaceuticals such as samarium and strontium
* PC-Spes =\< 4 weeks prior to study entry
* Failure to fully recover from adverse effects of prior therapies regardless of interval since last treatment
* Other concurrent chemotherapy, immunotherapy, or radiotherapy directed at the cancer
* Other therapy or supportive care that is considered investigational
* Known CNS metastases
* Known visceral metastases (pulmonary, liver, kidney, splenic lesions); patients with retroperitoneal, pelvic or inguinal lymph node metastases and/or disease in the prostate (or prostatic bed) will not be excluded
* Uncontrolled intercurrent illness including, but not limited to:
* Ongoing or active infection
* Symptomatic congestive heart failure
* Unstable angina pectoris, cardiac arrhythmia
* Psychiatric illness/social situations that would limit compliance with study requirements
* HIV-positive patients receiving combination anti-retroviral therapy
* Prior malignancy except for adequately treated basal cell or squamous cell skin cancer, adequately treated noninvasive carcinomas, or other cancer from which the patient has been disease free for \>= 5 years
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00039104
Study Brief:
Protocol Section:
NCT00039104