Hormone Suppression and Radiation Therapy for 6 Months With/Without Docetaxel for High Risk Prostate Cancer
This trial is active, not recruiting.
|Treatments||docetaxel, androgen hormonal suppression and radiation, androgen suppression therapy and radiation therapy|
|Sponsor||Dana-Farber Cancer Institute|
|Start date||June 2005|
|End date||January 2019|
|Trial size||350 participants|
|Trial identifier||NCT00116142, 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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
To determine if overall survival is increased
time frame: 2014
To determine if PSA doubling time is prolonged; To determine if PSA failure is decreased; To determine if cancer specific mortality is decreased
time frame: 2014
Male participants at least 30 years old.
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.
|Official title||Docetaxel Plus 6-month Androgen Suppression and Radiation Therapy Versus 6-month Androgen Suppression and Radiation Therapy for Patients With High Risk Localized or Locally Advanced Prostate Cancer: A Randomized Controlled Trial|
|Principal investigator||Anthony V. D'Amico, MD, PhD|
|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 docetaxel (Taxotere)will make this treatment more effective. Docetaxel has shown a benefit in median survival when given to men who have become resistant to hormonal therapy and in men who have metastatic prostate cancer (spread to other areas of the body).|
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