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:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 12:34 AM
NCT ID:
NCT00061867
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the prostate
* Rising prostate-specific antigen AND radiographic evidence of extraprostatic prostate cancer by bone scan, CT scan, prostascint scan, or MRI
PATIENT CHARACTERISTICS:
Age
* 40 and over
Performance status
* Karnofsky 80-100%
Life expectancy
* Not specified
Hematopoietic
* WBC greater than 4,000/mm\^3
* Platelet count greater than 100,000/mm\^3
* Hemoglobin greater than 10.0 g/dL
Hepatic
* Bilirubin normal
* AST normal
* Alkaline phosphatase normal
* No acute or chronic liver disease
Renal
* Creatinine less than 1.5 times upper limit of normal
Cardiovascular
* Ejection fraction at least 50% by MUGA
* EKG normal
* No myocardial infarction or cerebral vascular accident within the past 6 months
* No life threatening cardiac arrhythmias
* No congestive heart failure
* No cardiac pacemaker
* No peripheral arterial disease with intermittent claudication or Leriches syndrome (i.e., claudication of the buttocks or perineum)
Other
* Fertile patients must use effective barrier contraception during and for 3 months after study participation
* No sperm donation during and for 3 months after study participation
* Not febrile
* No interest in future fertility or fathering children
* No significantly decreased pain response
* No severe urethral stricture
* No protruding median lobe resulting in a "ball-valve" type of obstruction at the bladder neck
* No major psychiatric illness that would prevent informed consent
* No major psychiatric illness that required inpatient treatment within the past 3 months
* No psychological, family, sociological, or geographic condition that would preclude study compliance
* No allergy to eggs or egg products
* No urinary or prostatic infection
* No full urinary retention
* No penile or urinary sphincter implant
* No metallic implants in the pelvic or femoral area
* No other serious medical illness that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No concurrent live vaccines
Chemotherapy
* No prior anthracycline
* No concurrent streptozocin
Endocrine therapy
* No concurrent hormonal therapy (except luteinizing hormone-releasing hormone analog)
* No concurrent glucocorticoids administered at more than physiologic replacement doses (other than as an antiemetic)
Radiotherapy
* Not specified
Surgery
* More than 3 months since prior major surgery
Other
* No prior therapy that resulted in permanent reduction of pain response (e.g., prior surgery, regional or local anesthetic)
* No concurrent PC-SPES
* No concurrent cyclosporine, phenobarbital, or phenytoin
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
40 Years
Study:
NCT00061867
Study Brief:
Protocol Section:
NCT00061867