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 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 1:11 AM
NCT ID:
NCT00016393
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the prostate
* Stage D1 or D2 disease (T4, N0, M0; any T, N1-3, M0; or any T, any N, M1)
* Unresponsive or refractory to prior hormonal therapy by at least 1 of the following:
* Progression of unidimensionally measurable lesion outside of a prior radiation port
* Progression of non-measurable disease (e.g., bone scan)
* Rising prostate-specific antigen (PSA) on at least 2 consecutive measurements taken at least 7 days apart
* PSA at least 5 ng/mL
* No brain metastases
PATIENT CHARACTERISTICS:
Age:
* Not specified
Performance status:
* Zubrod 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Absolute granulocyte count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than upper limit of normal (ULN)
* SGOT or SGPT no greater than 2.5 times ULN
Renal:
* Creatinine no greater than 2.0 mg/dL OR
* Creatinine clearance at least 40 mL/min
Other:
* No other malignancy within the past 5 years except adequately treated squamous cell or basal cell skin cancer, any carcinoma in situ, or stage I or II cancer in complete remission
* No other concurrent significant active illness that would preclude study participation
* Recovered from major infections
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 28 days since prior biologic therapy and recovered
* No more than 1 prior biologic (non-cytotoxic) therapy
* No concurrent biological response modifiers
Chemotherapy:
* No prior chemotherapy for this disease
* No other concurrent chemotherapy
Endocrine therapy:
* See Disease Characteristics
* At least 28 days since prior flutamide or ketoconazole
* At least 42 days since prior bicalutamide or nilutamide
* No concurrent hormonal therapy, except luteinizing hormone-releasing hormone therapy
* No concurrent corticosteroids
Radiotherapy:
* See Disease Characteristics
* Prior radiotherapy to less than 30% of bone marrow allowed
* No prior strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium
* At least 28 days since prior radiotherapy and recovered
* No concurrent radiotherapy
Surgery:
* Recovered from prior surgery
* Prior orchiectomy allowed
Other:
* No concurrent unconventional therapy (e.g., St. John's Wort, PC-SPES, or other herbal remedy for prostate cancer)
* Not planning to begin bisphosphonate therapy (patients already receiving bisphosphonates are eligible provided they have progressive disease)
Healthy Volunteers:
False
Sex:
MALE
Study:
NCT00016393
Study Brief:
Protocol Section:
NCT00016393