Hormone Suppression and Radiation Therapy for 6 Months With/Without Docetaxel for High Risk Prostate Cancer

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: Docetaxel
* Drug: Androgen Hormonal Suppression and Radiation
* Drug: Androgen Suppression Therapy and Radiation Therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Arm1: Androgen Suppression Therapy + Radiation Therapy<br>Androgen Suppression Therapy and Radiation therapy | Drug: Androgen Hormonal Suppression and Radiation<br>* Total Androgen Ablation and external beam radiation therapy<br>Drug: Androgen Suppression Therapy and Radiation Therapy<br>* Total Androgen Ablation and External Beam Radiation Therapy<br>|
| Experimental: Arm 2: Docetaxel + Androgen Suppression Therapy + Radiation Therapy<br>Docetaxel plus androgen suppression therapy and radiation therapy | Drug: Docetaxel<br>* 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.<br>* Other names: Taxotere;Drug: Androgen Hormonal Suppression and Radiation<br>* Total Androgen Ablation and external beam radiation therapy<br>Drug: Androgen Suppression Therapy and Radiation Therapy<br>* Total Androgen Ablation and External Beam Radiation Therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 10-Year Restricted Mean Survival Time for Overall Survival | Overall survival (OS) was measured from the date of random assignment to death from any cause, censored at the date of last follow-up in surviving patients. The 10-Year Restricted Mean Survival Time was calculated as the area under the Kaplan Meier plot for OS, from randomization to 10-years follow-up | Following the end of RT patients were seen for follow up every 6 months for 5 years and annually thereafter, 10 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 10-year Biochemical Recurrence (PSA Failure) | Time to biochemical recurrence was defined as the time from date of random assignment to the earliest of PSA failure or initiation of salvage therapy, or censored at the date of last disease assessment for those without PSA failure. PSA failure was defined according to the 2006 RTOG-ASTRO Phoenix definition (i.e., A PSA rise by 2 ng/mL or more above the nadir). 10-year biochemical recurrence rate was estimated from a competing risk model where non-prostate cancer death was counted as competing risk. | PSA was measured following the end of RT, then every 6 months for 5 years and annually thereafter, 10 years | 
| 10-year Prostate Cancer Mortality | Measured from the date of random assignment to date of death from prostate cancer, or censored at the date of last follow-up in surviving patients. Patients who died due to other reasons were counted as competing risk in a competing risk model. | Following the end of RT patients were seen for follow up every 6 months for 5 years and annually thereafter, 10 years. | 
| Number of Participants With Acute Adverse Events | Adverse acute events were reported via the clinical database only for toxicities considered reportable via the SAE mechanism (those of grade 2 and grade 3 events that are unexpected and possibly, probably, or definitely related/associated with treatment; or all grade 4 and grade 5 events). Common Toxicity Criteria Volume 3.0 (CTCAE) is used for this study. | During study treatment or within 30 days of the last dose of study, up to 7.2 months from randomization | 
| Number of Participants With Late Adverse Events, Any Grade and Attribution | Late adverse events will be focused on GU/GI including Urinary/Fecal Incontinence, Hematuria, Diarrhea, Rectal Bleeding and other. | Every 6 months post radiation therapy for 5 years (+/-90 days), then annually, up to 13.9 years from randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hormone Refractory, Localized, Locally Advanced, Prostate Cancer - High Risk Localized or Locally Advanced, Prostate Cancer, Metastatic