Status:
COMPLETED
Hormone Suppression and Radiation Therapy for 6 Months With/Without Docetaxel for High Risk Prostate Cancer
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Sanofi
Conditions:
Prostate Cancer
Eligibility:
MALE
30+ years
Phase:
PHASE3
Brief Summary
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.
Detailed Description
Radiation therapy plus six months of hormone therapy is one standard way of treating men with high-risk prostate cancer. In this study, we want to see whether or not adding the chemotherapy drug docet...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 29 2020
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT00116142
Start Date
June 1 2005
End Date
June 29 2020
Last Update
January 11 2022
Active Locations (1)
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1
Dana-Farber Cancer Institute and (Sanofi-Aventis Consortium)
Boston, Massachusetts, United States, 02115