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 @ 3:48 AM
Ignite Modification Date:
2025-12-25 @ 3:48 AM
NCT ID:
NCT00077402
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed adenocarcinoma of the prostate
* Measurable or non-measurable disease
* Metastatic disease allowed
* Castrate levels of serum testosterone (either after orchiectomy or maintained on a luteinizing hormone-releasing hormone agonist or antagonist)
* Prostate-specific antigen (PSA) greater than 10 ng/mL at baseline and rising, with 2 consecutive increases measured at least 1 week apart\*
* No known brain metastases NOTE: \*If the third PSA value has not risen above the second PSA value, a fourth measurement must be obtained that is higher than the second value
PATIENT CHARACTERISTICS:
Age
* Over 18
Performance status
* ECOG 0-1
Life expectancy
* More than 12 weeks
Hematopoietic
* Absolute neutrophil count greater than 1,500/mm\^3
* WBC greater than 3,000/mm\^3
* Platelet count greater than 100,000/mm\^3
Hepatic
* AST and ALT no greater than 2.5 times upper limit of normal
* Bilirubin normal
Renal
* Creatinine normal OR
* Creatinine clearance greater than 60 mL/min
Cardiovascular
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
Other
* Able to tolerate oral medication
* Fertile patients must use effective contraception
* No prior allergic reaction to compounds of similar chemical or biological composition to fenretinide
* No other concurrent uncontrolled illness
* No ongoing or active infection
* No psychiatric illness or social situation that would preclude study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No prior cytotoxic chemotherapy
Endocrine therapy
* See Disease Characteristics
* At least 6 weeks since prior antiandrogen therapy with any of the following:
* Cyproterone
* Flutamide
* Bicalutamide
* Nilutamide
* Concurrent corticosteroids allowed provided therapy was initiated before study entry
Radiotherapy
* At least 4 weeks since prior radiotherapy and recovered
* No concurrent radiotherapy, including for pain
* No concurrent radioisotopes (e.g., strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium)
Other
* More than 4 weeks since prior investigational agents
* No concurrent antioxidants (e.g., ascorbic acid or vitamin E), vitamin A, or beta carotene supplements
* No concurrent combination antiretroviral therapy for HIV-positive patients
* No other concurrent investigational or commercial anticancer agents or therapies
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00077402
Study Brief:
Protocol Section:
NCT00077402