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, Dana Farber Cancer Institute at South Shore Hospital

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
Kelly Swanson, DO, Cape Cod Healthcare

Contacts:
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
Dana Farber Cancer Institute at South Shore Hospital: James Paidas, 617-624-4787
Dana-Farber Cancer Institute: Marie Allen, 617-632-4420

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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