Study of MDV3100 as a Neoadjuvant Therapy for Patients Undergoing Prostatectomy for Localized Prostate Cancer
Status: Recruiting
Phase:
Diagnosis: Prostate Cancer
NCT ID: NCT01547299
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-089
The purpose of this study is to determine if MDV3100 is an effective therapy in treating localized prostate cancer prior to prostatectomy.
Conducting Institutions:
Brigham and Women's Hospital, Beth-Israel Deaconess Medical Center, Dana-Farber Cancer Institute
Overall PI:
Mary-Ellen Taplin, MD,
Dana-Farber Cancer Institute
Site-responsible Investigators:
Glenn Bubley, MD,
Beth Israel Deaconess Medical Center
Contacts:
Dana-Farber Cancer Institute:
Judith Prisby, 617-632-5068,
jprisby@partners.org
Beth-Israel Deaconess Medical Center:
Cancer Trials Call Center, 617-667-3060
Eligibility Criteria
Inclusion Criteria:
- Willing to provide informed consent
- 18 years of age or older
- Histologically confirmed adenocarcinoma of the prostate
- Must be a candidate for radical prostatectomy and considered surgically resectable
Exclusion Criteria:
- Stage T4 prostate cancer by clinical or radiologic evaluation
- Treatment with an investigational agent within 4 weeks prior to randomization
- Received therapy for for other neoplastic disorders within 5 years
- Hypogonadism or severe androgen deficiency