Hormone Suppression and Radiation Therapy for 6 Months With/Without Docetaxel for High Risk Prostate Cancer

Status: Recruiting
Phase: Phase 3
Diagnosis: Prostate Cancer
NCT ID: NCT00116142 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 05-043


This randomized study is looking at the benefits of using docetaxel (chemotherapy) added to one of the standard treatments (radiation and hormones) for men with high-risk prostate cancer.


Conducting Institutions:
Dana-Farber Cancer Institute, Beth-Israel Deaconess Medical Center, Brigham and Women's Hospital, Cape Cod Healthcare, DF/BWCC at South Shore Hospital, Dana Farber Cancer Institute at Milford

Overall PI:
Anthony D'Amico, MD, PhD, Dana-Farber Cancer Institute

Site-responsible Investigators:
Glenn Bubley, MD, Beth Israel Deaconess Medical Center
Philip Kantoff, MD, Dana-Farber Cancer Institute
Rolf Freter, MD, Ph.D., Dana Farber Cancer Institute at South Shore
Frank Basile, M.D, Cape Cod HealthCare
Michael Constantine, M.D., Dana Farber Cancer Institute at Milford Hosptial

Brigham and Women's Hospital: Marion Loffredo, 617-355-7264, mloffredo@lroc.harvard.edu
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060
Cape Cod Healthcare: Rebecca Buscanera, RN
DF/BWCC at South Shore Hospital: James Paidas, 617-624-4787
Dana-Farber Cancer Institute: Judith Prisby, 617-632-5068, jprisby@partners.org
Dana-Farber Cancer Institute: Amanda Fredericks, 617-632-5514, acfredericks@partners.org
Dana-Farber Cancer Institute: Meghara Walsh, 617-632-5264, mwalsh10@partners.org

Eligibility Criteria

Inclusion Criteria: - Biopsy proven prostate cancer - Clinical Tumor Category T1b, T1c, T2a and PSA greater than (>) 10 or Gleason score equal or greater than 4+3=7 or PSA velocity > 2.0 ng/ml per year and also eligible patients with tumor category T2c, T3a, T3b, or T4 as per 2002 AJCC guidelines. Any minor tertiary grade of Gleason 5; Biopsy Proven or Radiographic (erMRI Seminal Vesicle Invasion); Gleason = or > 3+4=7 with 50% or more cores positive - Negative bone scan - Lymph node assessment by CT or MR - Adequate hematologic function (Blood Counts) - Adequate liver functions (blood tests) - ECOG performance Status 0 or 1 - Peripheral neuropathy must be =< grade 1 - PSA obtained within 3 months of entry Exclusion Criteria: - Prior history of malignancy that are < 5 years except for cancers found to be "in-situ" and would not likely impact a patient's life expectancy with appropriate medical management. - Prior pelvic radiation therapy - Prior hormonal therapy (up to 4 weeks prior to enrollment allowed) - Individuals unable to tolerate lying still 5 - 10 minutes - Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 90.
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