This trial is active, not recruiting.

Condition prostate cancer
Treatments docetaxel, androgen hormonal suppression and radiation, androgen suppression therapy and radiation therapy
Phase phase 3
Sponsor Dana-Farber Cancer Institute
Collaborator Sanofi
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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Androgen Suppression Therapy and Radiation therapy
androgen hormonal suppression and radiation
Total Androgen Ablation and external beam radiation therapy
androgen suppression therapy and radiation therapy
Total Androgen Ablation and External Beam Radiation Therapy
Docetaxel plus androgen suppression therapy and radiation therapy
docetaxel Taxotere
60 mg/m² q 3 weeks for 3 cycle at the start of treatment followed by weekly Docetaxel at 20 mg/m² per week beginning at week one of radiation therapy and continuing for seven weeks.

Primary Outcomes

To determine if overall survival is increased
time frame: 2014

Secondary Outcomes

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

Eligibility Criteria

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.

Additional Information

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).
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Dana-Farber Cancer Institute.