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.