| Requirement |
1 | Histologically documented adenocarcinoma of the prostate. |
2 | Status post radical prostatectomy with sampling of the pelvic lymph nodes with
histologically confirmed adenocarcinoma of the prostate, with at least 1 of 3
disease criteria which must be met as indicated below:
a) Pathologic T2N0M0 disease with positive margins and gleason score greater than or equal to 8
b) Pathologic T3aN0M0 disease with extracapsular extension and Gleason Score
greater than or equal to 8
c) Pathologic T3bN0M0 disease |
3 | Undetectable PSA level (i.e., less than or equal to 0.2 ng/ml) within 8 weeks after radical
prostatectomy |
4 | No prior chemotherapy, pelvic irradiation, or androgen ablation |
5 | Karnofsky Performance Status greater than or equal to 70 |
6 | Hematologic parameters must be within the following limits:
-WBC greater than or equal to 3,000
-Platelet Count greater than or equal to 130,000
-Hemoglobin level greater than or equal to 11.0
-Creatinine less than or equal to 2.5 |
7 | Normal liver function |
8 | Patients with a history of an invasive malignancy within the last 5 years are not
eligible for the protocol; patients who are NED from a prior invasive
malignancy for at least 5 years or longer are eligible for the trial. Patients with
history of benign tumors such as pituitary macroadenomas, meningiomas, or
craniopharyngiomas are eligible as long as the benign tumor is under local
control regardless of the time frame. Patients with concurrent adequately treated
basal cell or squamous cell carcinoma of the skin are also eligible for the
protocol. |
9 | Patients must be informed of the investigative nature of the treatment, must give
appropriate informed consent to protocol procedures and must sign an Informed
Consent Documentation Form. |
10 | Must not have concomitant medical, psychological or social circumstances
which would interfere with compliance with the protocol treatment and followup. |
11 | Age greater than or equal to 18 years |
12 | Men of childbearing potential must be willing to consent to using effective
contraception while on treatment and for a reasonable period thereafter, which
should be for at least 6 months after the completion of protocol therapy. |
1 | Patients who have received prior chemotherapy, pelvic irradiation or androgen
ablation including neoadjuvant hormonal therapy prior to radical prostatectomy. |
2 | Any coexisting medical condition precluding full compliance with the study. |
3 | Patients with active infections or known infection with HIV. |
4 | Psychological, familiar, sociological or geographical conditions which would
not permit compliance with the study protocol. |
5 | Known contraindication to dexamethasone (allergic reaction or systemic fungal
infection). |
6 | Pre-existing Grade greater than or equal to 1 peripheral neuropathy. |
7 | Patients with a history of a hypersensitivity reaction to products containing
Polysorbate 80 (Tween 80). |