The purpose of this study is to compare the effects on prostate cancer using radiation therapy with or without chemotherapy.
The recommended treatment for a high risk prostate cancer consists of a combination of radiation therapy and androgen suppression for 2-3 years. Recent studies have shown a survival advantage for chemotherapy for prostate cancer. Chemotherapy has already been successfully integrated in the treatment of other cancer types and is our belief that chemotherapy will prove to be beneficial for patients with high risk prostate cancer. However, a clinical study is necessary to compare the results good or bad of chemotherapy with radiation therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin.
Docetaxel 20mg/m2 IV every 7 days x 8 weeks.
1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy).
CDH Proton Center
Warrenville, Illinois, United States
Procure Proton Therapy Center
Oklahoma City, Oklahoma, United States
Hampton University Proton Therapy Institute
Hampton, Virginia, United States
Phase 2 - Assessment of Number of Freedom From Failure Events in the Chemotherapy Arm
Measurement of Freedom from Failure i.e. the first occurence of clinical failure (local recurrence, regional recurrence, or distant metastasis), biochemical failure by the Phoenix definition (Prostate Specific Antigen \[PSA\] \> = 2 ng/ml over the nadir PSA discounting bounces per the investigators discretion), or the start of salvage therapy including androgen deprivation. This study was terminated prior to the time frame of 2 years being reached. Therefore, this outcome was assessed at time of study closure (22 months).
Time frame: No failures were reported at the time of study termination (22 months). This outcome was originally written to assess failure at 2 years. However, that end point was not reached.
Phase 2 - Assessment of Number of Freedom From Failure Event Comparing Chemotherapy Arm to Standard Treatment Arm
This endpoint will be examined if decision is made to not move forward with phase 3 study. This study was terminated prior to a decision being made about moving on to a phase 3 study. Therefore, this outcome was not assessed.
Time frame: at 5 years
Phase 2 - Cumulative Number of Incidences of Grade 3 or Higher Adverse Events.
Assessment will be performed using CTCAE v4 criteria. This study was terminated prior to the time frame of 2 years being reached. Therefore, this outcome was assessed at time of study closure (22 months).
Time frame: 2 years
Phase 3 - Assessment of the Number of Freedom From Failure (FFF) Events Comparing the Chemotherapy Arm to the Standard Treatment Arm.
The events for FFF will be the first occurence of clinical failure (local recurrence, regional recurrence, or distant metastasis), biochemical failure by the Phoenix definition (PSA \> = ng/ml over the nadir PSA discounting bounces per the investigators discretion), or the start of salvage androgen deprivation. This study was terminated prior to a decision being made about moving on to a phase 3 study. Therefore, this outcome was not assessed.
Time frame: at 5 years
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Assessment of Number of Grade 2 or Higher Genitourinary (GU) and Gastrointestinal (GI) Adverse Events
Assessment will be performed using CTCAE v 4 criteria.
Time frame: at 6 months
Assessment of Number of GI and GU Adverse Events
Descriptive measurements of frequency will be compiled. This study was terminated prior to the time frame of 3 years being reached. Therefore, this outcome was not assessed. Data were collected on toxicities up until study closure at 22 months. However, this timepoint was not indicated as a secondary objective in the protocol. Therefore, data was not analyzed at time of study closure.
Time frame: at 3 years
Assessment of Total Number of Local/Distant Failures
The total number of local/distant failures will be assessed.
Time frame: at time of study closure (22 months)
Assessment of Impotence by Summation of Relative Scores for Sexual Function From the EPIC Quality of Life Instrument.
unable to assess due to lack of data
Time frame: Up to 10 years
Assessment of Total Number of Salvage Androgen Deprivation Use With Comparison of Arms.
The total number of subjects with salvage androgen deprivation use will be assessed.
Time frame: At study closure (22 months)
Assessment of Total Number of Survival Events With Comparison of Group Arms
The number of deaths in both arms will be assessed.
Time frame: at study closure (22 months)
Assessment of Total Number of Biochemical Failure Events
The number of biochemical failure events will be assessed on both arms.
Time frame: at study closure (22 months)
Assessment of Quality of Life - Summation of Relative Scores From the EPIC Instrument.
unable to assess due to lack of data
Time frame: Up to 10 years