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 @ 2:48 AM
Ignite Modification Date:
2025-12-25 @ 2:48 AM
NCT ID:
NCT00036933
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed prostate cancer
* Disease progression after primary surgery (radical prostatectomy) or radiotherapy with or without prior neoadjuvant androgen ablation
* Minimum of 3 rising PSA values, taken at least 2 weeks apart, with more than a 50% rise in PSA level above the baseline value (1.0 ng/mL post -prostatectomy or 2.0 ng/mL post-radiotherapy)
* Received prior intermittent hormonal therapy after prior primary therapy
* Non-castrate levels of testosterone (more than 50 ng/mL)
* Evaluable disease (by serial changes in PSA)
* No radiographic evidence of metastatic disease
* No active CNS or epidural tumor
* No soft tissue and/or bone disease
* No androgen-independence with no evidence of radiographic disease
* May not be symptomatic or anticipated to develop symptoms within 6 months of study entry
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Karnofsky 70-100%
Life expectancy:
* At least 6 months
Hematopoietic:
* WBC at least 3,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin less than 2.0 mg/dL
* SGOT less than 3 times upper limit of normal
Renal:
* Creatinine no greater than 2.0 mg/dL OR
* Creatinine clearance at least 40 mL/min
Cardiovascular:
* No clinically significant cardiac disease (New York Heart Association class III or IV)
Pulmonary:
* No severe debilitating pulmonary disease
Other:
* No allergy to seafood (shellfish)
* No other active malignancy within the past 5 years except nonmelanoma skin cancer
* No infection requiring antibiotics
* No narcotic-dependent pain
* No positive stool guaiac unless associated with hemorrhoids or prior documented radiation-induced proctitis
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* At least 4 weeks since prior chemotherapy
Endocrine therapy:
* See Disease Characteristics
* See Chemotherapy
* At least 2 weeks since change in hormonal therapy (e.g., prednisone or dexamethasone) except to maintain castrate levels of testosterone
Radiotherapy:
* See Disease Characteristics
* At least 4 weeks since prior radiotherapy
* No concurrent irradiation of only measurable lesion
Surgery:
* See Disease Characteristics
* No concurrent surgery of only measurable lesion
Other:
* Recovered from prior therapy
* At least 8 weeks since prior suramin and/or documented plasma concentration of suramin if less than 50 micrograms/mL (replacement hydrocortisone allowed)
* No other concurrent oncolytic agents
* No concurrent immunosuppressive therapy
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00036933
Study Brief:
Protocol Section:
NCT00036933