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 @ 1:08 AM
Ignite Modification Date:
2025-12-25 @ 1:08 AM
NCT ID:
NCT01079793
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of adenocarcinoma of the prostate
* Must have undergone any common form of prostatectomy (e.g., open, perineal, laparoscopic, or robotic) within the past 2 years
* T3 disease or positive surgical margins
* Node negative (N0) and free of distant metastasis (M0) by a bone scan and CT scan or MRI of the pelvis within the past 90 days
* Considered high-risk disease
* Gleason score = 7 and post-operative PSA \> 0 and ≤ 2 ng/mL OR Gleason score ≥ 8 and post-operative PSA ≥ 0 and ≤ 2 ng/mL
* Pre-prostatectomy PSA available
* Range of pre-prostatectomy PSA values not required
PATIENT CHARACTERISTICS:
* Zubrod (ECOG) performance status 0-1
* ANC ≥ 2,000/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 8 g/dL
* Total bilirubin \< 1.5 times upper limit of normal (ULN)
* AST and ALT \< 2.5 times ULN
* Alkaline phosphatase \< 2.5 times ULN
* Fertile patients must use effective contraception during and for 4 weeks after completion of study therapy
* Patients with urinary incontinence waiting for stabilization of urinary function after prostatectomy allowed for up to 6 months
* No CTCv4 peripheral neuropathy (motor or sensory) ≥ grade 1
* No history of inflammatory colitis including Crohn disease or ulcerative colitis
* No significant history of psychiatric illness
* No other invasive malignancy within the past 3 years except adequately treated nonmelanoma skin cancer or carcinoma in situ of the oral cavity
* No severe, active co-morbidity with any of the following:
* Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
* Transmural myocardial infarction within the past 6 months
* Acute bacterial or fungal infection requiring IV antibiotics
* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days
* Immunocompromised patients or AIDS based upon current CDC definition
* HIV testing not required
* No history of hypersensitivity reactions to agents containing Cremophor® EL or its derivatives (e.g., polyoxyethylated castor oil)
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior pelvic radiotherapy or radiotherapy for another malignancy that encompasses ≥ 30% of major bone marrow-containing areas (e.g., pelvis or lumbar spine)
* No prior hormonal therapy for prostate cancer
* Prior hormonal agents, e.g., finasteride or dutasteride, for benign prostatic hypertrophy allowed
* No other concurrent adjuvant antineoplastic therapy planned while on this protocol, including the following:
* Cryotherapy
* Hormonal therapy
* Other chemotherapy for prostate cancer
* Prior chemotherapy for a different type of cancer allowed provided it was administered \> 3 years ago
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT01079793
Study Brief:
Protocol Section:
NCT01079793