University of Southern California
USC Norris Comprehensive Cancer Center
If you are a patient, please contact Keck Medical Center of USC at 800-USC-CARE.

Trial 4P-06-3


A Phase I/II Trial of Adjuvant Post-Prostatectomy 3-D Conformal Radiation Therapy, Hormonal Therapy, and Concurrent Docetaxel for High Risk Pathologic T2-T3N0 Prostate Cancer.

Type: Treatment
Phase: Phase I/II
Status: Open to Accrual
Treatments: Chemotherapy: Systemic, Hormone, Radiation: External
Randomized: No
Defintions of terms and FAQ about clinical trials.
Trial Leaders/Researchers:  Jacek Pinski, MD,PHD
Other Trial Staff:  Charlean Ketchens, R.N., Lagrimas Ilagan, D.M., Roberto Tejada, D.M., Carrie Korn, R.N., Shamim Jhimlee, Coordinator

Staff may log in to see study documents.


You may participate in this study if:
 Requirement
1Histologically documented adenocarcinoma of the prostate.
2Status 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
3Undetectable PSA level (i.e., less than or equal to 0.2 ng/ml) within 8 weeks after radical prostatectomy
4No prior chemotherapy, pelvic irradiation, or androgen ablation
5Karnofsky Performance Status greater than or equal to 70
6Hematologic 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
7Normal liver function
8Patients 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.
9Patients 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.
10Must not have concomitant medical, psychological or social circumstances which would interfere with compliance with the protocol treatment and followup.
11Age greater than or equal to 18 years
12Men 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.


You may not participate in this study if:
1Patients who have received prior chemotherapy, pelvic irradiation or androgen ablation including neoadjuvant hormonal therapy prior to radical prostatectomy.
2Any coexisting medical condition precluding full compliance with the study.
3Patients with active infections or known infection with HIV.
4Psychological, familiar, sociological or geographical conditions which would not permit compliance with the study protocol.
5Known contraindication to dexamethasone (allergic reaction or systemic fungal infection).
6Pre-existing Grade greater than or equal to 1 peripheral neuropathy.
7Patients with a history of a hypersensitivity reaction to products containing Polysorbate 80 (Tween 80).



For further information on a study, please contact the Clinical Investigation Support Office at (323) 865-0451, or clinical.trials@med.usc.edu.

To schedule a consultation with the hospital, please call our New Patient Referrals Office at (323) 865-3111.