Docetaxel, Androgen Ablation, and External-Beam Radiation Therapy in Patients With High-Risk Localized Prostate Cancer (NRR)
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ClinicalTrials.gov Identifier: NCT00225420 |
Recruitment Status :
Completed
First Posted : September 23, 2005
Results First Posted : June 1, 2017
Last Update Posted : June 1, 2017
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Prostate Cancer |
Interventions |
Drug: docetaxel Drug: leuprolide acetate Radiation: radiation therapy |
Enrollment | 23 |
Recruitment Details | Subjects with high-risk or locally advanced prostate cancer were recruited from 2 institutions between December 2005 and January 2010. |
Pre-assignment Details | Two patients were taken off the study due illness, two were removed because they were too large for the equipment, and one was removed due to CT screen failure.18 men with high-risk or locally advanced prostate cancer were enrolled. All 18 patients completed their radiation therapy and 16 completed all planned chemotherapy doses. |
Arm/Group Title | Docetaxel 10 mg/m2 | Docetaxel 15 mg/m2 | Docetaxel 20 mg/m2 |
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Single Arm docetaxel: Docetaxel will be administered per the designated cohort starting at 10 mg/m2 intravenously over 1 hour weekly for eight weeks, for a total of eight treatments. leuprolide acetate: Leuprolide acetate will be administered at 22.5 mg intramuscular (IM) and will be initiated 2 to 3 months prior to radiotherapy and chemotherapy with docetaxel. radiation therapy: The total dose will be 7800 centigray (cGy) in 200 cGy per fraction for a total of 39 treatments. |
Single Arm docetaxel: Docetaxel will be administered per the designated cohort starting at 15 mg/m2 intravenously over 1 hour weekly for eight weeks, for a total of eight treatments. leuprolide acetate: Leuprolide acetate will be administered at 22.5 mg intramuscular (IM) and will be initiated 2 to 3 months prior to radiotherapy and chemotherapy with docetaxel. radiation therapy: The total dose will be 7800 cGy in 200 cGy per fraction for a total of 39 treatments |
Single Arm docetaxel: Docetaxel will be administered per the designated cohort starting at 20 mg/m2 intravenously over 1 hour weekly for eight weeks, for a total of eight treatments. leuprolide acetate: Leuprolide acetate will be administered at 22.5 mg intramuscular (IM) and will be initiated 2 to 3 months prior to radiotherapy and chemotherapy with docetaxel. radiation therapy: The total dose will be 7800 cGy in 200 cGy per fraction for a total of 39 treatments |
Period Title: Overall Study | |||
Started | 9 | 6 | 3 |
Completed | 9 | 6 | 3 |
Not Completed | 0 | 0 | 0 |
Arm/Group Title | Overall Study | |
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Single Arm Docetaxel: Docetaxel will be administered per the designated cohort starting at 10, 15 or 20 mg/m2 intravenously over 1 hour weekly for eight weeks, for a total of eight treatments. leuprolide acetate: Leuprolide acetate will be administered at 22.5 mg IM and will be initiated 2 to 3 months prior to radiotherapy and chemotherapy with docetaxel. radiation therapy: The total dose will be 7800 cGy in 200 cGy per fraction for a total of 39 treatments. |
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Overall Number of Baseline Participants | 18 | |
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All patients included in this trial were high-risk localized (Gleason 8-10 or PSA level >= 20 ng/mL) prostate cancer, or T3 disease.
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Age, Continuous
Mean (Full Range) Unit of measure: Years |
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Number Analyzed | 18 participants | |
62
(45 to 77)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 18 participants | |
Female |
0 0.0%
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Male |
18 100.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 18 participants | |
American Indian or Alaska Native |
0 0.0%
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Asian |
0 0.0%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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Black or African American |
4 22.2%
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White |
14 77.8%
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More than one race |
0 0.0%
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Unknown or Not Reported |
0 0.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 18 participants |
18 | ||
Clinical Stage
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 18 participants | |
T1c-T2a |
9 50.0%
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T2b-T2c |
5 27.8%
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T3 |
4 22.2%
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[1]
Measure Description: The Classification of Malignant Tumours (TNM) system is a widely used cancer staging system. The T refers to the size and extent of the main tumor. The main tumor is usually called the primary tumor. T0 means the main tumor cannot be found. The higher the number following T, the larger the tumor or the more it has grown.
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Gleason Score
[1] Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 18 participants |
Grade 7 |
3 16.7%
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Grade 8-10 |
15 83.3%
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[1]
Measure Description: A Gleason score is given based on how the prostate cancer tissue looks under the microscope. Gleason scores range from 2 to 10 and indicates how likely the tumor will spread. The higher the Gleason score the more likely the cancer tissue will spread.
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PSA level, ng/mL
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 18 participants | |
<10 ng/mL |
6 33.3%
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10-19 ng/mL |
4 22.2%
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20-100 ng/mL |
5 27.8%
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>100 ng/mL |
3 16.7%
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[1]
Measure Description: Prostate-specific antigen (PSA) is a protein produced by cells of the prostate gland. The PSA test measures the level of PSA in the blood. PSA levels are often elevated in men with prostate cancer.
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Name/Title: | Robin V. Johnson |
Organization: | Lineberger Comprehensive Cancer Center |
Phone: | 919-966-1125 |
EMail: | robin_v_johnson@med.unc.edu |
Responsible Party: | UNC Lineberger Comprehensive Cancer Center |
ClinicalTrials.gov Identifier: | NCT00225420 |
Other Study ID Numbers: |
LCCC 0420 |
First Submitted: | September 21, 2005 |
First Posted: | September 23, 2005 |
Results First Submitted: | March 9, 2017 |
Results First Posted: | June 1, 2017 |
Last Update Posted: | June 1, 2017 |