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-10-8


PREVAIL: A Multi-National Phase III, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Oral MDV3100 in Chemotherapy-Naïve Patients with Progressive Metastatic Prostate Cancer Who Have Failed Androgen Deprivation Therapy.

Type: Treatment
Phase: Phase III
Status: Open to Accrual
Treatments: Chemotherapy: Systemic
Randomized: Yes
Defintions of terms and FAQ about clinical trials.
Trial Leaders/Researchers:  Tanya Dorff, M.D.
Other Trial Staff:  Charlean Ketchens, R.N., Lagrimas Ilagan, D.M., Roberto Tejada, D.M., Kristy Sartor Massopust, Coordinator, Yvette Viverette, R.N., Elysse Faye Ballon, Coordinator

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You may participate in this study if:
 Requirement
1Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features
2Ongoing androgen deprivation therapy with a GnRH analogue or bilateral orchiectomy (i.e., surgical or medical castration)
3Patients who have not had a bilateral orchiectomy must have a plan to maintain effective GnRH-analogue therapy for the duration of the trial
4Serum testosterone level < / = 1.73 nmol/l (50 ng/dl) at the screening visit
5Patients receiving bisphosphonate therapy must have been on stable doses for at least 4 weeks
6Progressive disease at study entry - defined as one or more of the following three criteria that occurred while the patient was on androgen deprivation therapy: [a] PSA progression defined by a minimum of two rising PSA levels with an interval of = / > 1 week between each determination. Patients who received an anti-androgen must have progression after withdrawal (= / > 4 weeks since last flutamide or = / > 6 weeks since last bicalutamide or nilutamide). The PSA value at the screening visit should be = / > 2 µg/l (2 ng/ml); [b] Soft tissue disease progression defined by RECIST 1.1; [c] Bone disease progression defined by PCWG2 with two or more new lesions on bone scan
7Metastatic disease documented by bone lesions on bone scan or by measurable soft tissue disease by CT/MRI. Patients whose disease spread is limited to regional pelvic lymph nodes are not eligible
8Asymptomatic or mildly symptomatic from prostate cancer
9ECOG performance status 0–1
10Estimated life expectancy of = / > 6 months
11AGC = / > 1.5; platelets = / > 100,000; Hgb = / > 9.0 (NOTE: Patients may not have received any growth factors within 7 days or blood transfusions within 28 days of the hematologic lab values obtained at the screening visit)
12Total bilirubin, SGOT or SGPT < / = 2.5 x uln at screening; albumin = / > 3.0 at screening
13Creatinine < / = 2.0 at screening
14Able to swallow the study drug and comply with study requirements
15Signed an approved study-specific informed consent and HIPAA


You may not participate in this study if:
1Prior cytotoxic chemotherapy for prostate cancer
2Severe concurrent disease, infection, or co-morbidity that, in the judgment of the investigator, would make the patient inappropriate for enrollment
3Known or suspected brain metastasis or active leptomeningeal disease
4History of another malignancy within the previous 5 years other than curatively treated non-melanomatous skin cancer
5History of seizure or any condition that may predispose to seizure. Also, history of loss of consciousness or TIA within 12 months of enrollment
6Clinically significant cardiovascular disease including: [a] MI within 6 months; [b] uncontrolled angina within 3 months; [c] CHF NYHA class 3 or 4, or patients with history of CHF NYHA class 3 or 4 in the past, unless a screening echocardiogram or multi-gated acquisition scan performed within 3 months results in a LVEF = / > 45%; [d] History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes); [e] History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place; [f] Hypotension as indicated by systolic BP < 86 mmHg at the screening visit; [g] Bradycardia as indicated by a heart rate of <50 beats/min on the screening ECG; [h] Uncontrolled HTN as indicated by systolic BP >170 mmHg or diastolic BP >105 mmHg at the screening visit.
7GI disorder affecting absorption (e.g., gastrectomy, active PUD within last 3 months
8Major surgery within 4 weeks of enrollment
9Use of opiate analgesics for pain from prostate cancer within 4 weeks of enrollment
10RT for treatment of the primary tumor within 3 weeks of enrollment
11RT or radionuclide therapy for treatment of metastasis
12Treatment with flutamide within 4 weeks of enrollment
13Treatment with bicalutamide or nilutamide within 6 weeks of enrollment
14Treatment with 5-alpha reductase inhibitors (finasteride, dutasteride), estrogens, cytproterone within 4 weeks of enrollment
15Treatment with systemic biologic therapy for prostate cancer (other than approved bone targeted agents and GnRH-analogue therapy) or other agents with anti-tumor activity within 4 weeks of enrollment
16History of prostate cancer progression on ketoconazole
17Prior use, or participation in a clinical trial, of an investigational agent that blocks androgen synthesis (e.g., abiraterone acetate, TAK-700, TAK-683, TAK-448) or blocks the androgen receptor (e.g., BMS 641988)
18Participation in a previous clinical trial of MDV3100
19Use of an investigational agent within 4 weeks of enrollment
20Use of herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels (e.g., saw palmetto) or systemic corticosteroids greater than the equivalent of 10 mg of prednisone per day within 4 weeks of enrollment
21Any condition or reason that, in the opinion of the investigator, interferes with the ability of the patient to participate in the trial, which places the patient at undue risk, or complicates the interpretation of safety data



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.