Trial Outcomes & Findings for Docetaxel, Androgen Ablation, and External-Beam Radiation Therapy in Patients With High-Risk Localized Prostate Cancer (NCT NCT00225420)
NCT ID: NCT00225420
Last Updated: 2017-06-01
Results Overview
Determine the number of patients experiencing dose-limiting toxicities (DLT) at each dose level. DLT was defined as grade 3-4 non-haematological or grade 4 haematological toxicity, using the Common Terminology Criteria for Adverse Events, version 3.0.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
23 participants
Primary outcome timeframe
Average follow up of 2 years
Results posted on
2017-06-01
Participant Flow
Subjects with high-risk or locally advanced prostate cancer were recruited from 2 institutions between December 2005 and January 2010.
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.
Participant milestones
| Measure |
Docetaxel 10 mg/m2
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.
|
Docetaxel 15 mg/m2
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
|
Docetaxel 20 mg/m2
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
9
|
6
|
3
|
|
Overall Study
COMPLETED
|
9
|
6
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Docetaxel, Androgen Ablation, and External-Beam Radiation Therapy in Patients With High-Risk Localized Prostate Cancer
Baseline characteristics by cohort
| Measure |
Overall Study
n=18 Participants
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.
|
|---|---|
|
Age, Continuous
|
62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
|
Clinical Stage
T1c-T2a
|
9 Participants
n=5 Participants
|
|
Clinical Stage
T2b-T2c
|
5 Participants
n=5 Participants
|
|
Clinical Stage
T3
|
4 Participants
n=5 Participants
|
|
Gleason Score
Grade 7
|
3 Participants
n=5 Participants
|
|
Gleason Score
Grade 8-10
|
15 Participants
n=5 Participants
|
|
PSA level, ng/mL
<10 ng/mL
|
6 Participants
n=5 Participants
|
|
PSA level, ng/mL
10-19 ng/mL
|
4 Participants
n=5 Participants
|
|
PSA level, ng/mL
20-100 ng/mL
|
5 Participants
n=5 Participants
|
|
PSA level, ng/mL
>100 ng/mL
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Average follow up of 2 yearsDetermine the number of patients experiencing dose-limiting toxicities (DLT) at each dose level. DLT was defined as grade 3-4 non-haematological or grade 4 haematological toxicity, using the Common Terminology Criteria for Adverse Events, version 3.0.
Outcome measures
| Measure |
Docetaxel at 10 mg/m2
n=9 Participants
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 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.
|
Docetaxel 15 mg/m2
n=6 Participants
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 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
|
Docetaxel 20 mg/m2
n=3 Participants
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 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
|
|---|---|---|---|
|
Number of Patients Experiencing Dose-Limiting Toxicities
|
1 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Average follow up of 2 yearsMeasure of the activity of a treatment on a disease. In this study it is measured from the date of enrollment to the date on which the prostate cancer progresses or the date the patient dies. Survival curves were estimated using the Kaplan-Meier technique. Biochemical (PSA) failure is defined, in accordance to the American Society for Therapeutic Radiology and Oncology consensus definition, as three consecutive rise in PSA. The date of biochemical failure is considered to be the midpoint between the last non-rising PSA and the first rising PSA.
Outcome measures
| Measure |
Docetaxel at 10 mg/m2
n=18 Participants
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 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.
|
Docetaxel 15 mg/m2
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 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
|
Docetaxel 20 mg/m2
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 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
|
|---|---|---|---|
|
Biochemical Progression-free Survival (PFS)
|
94 percentage of patients
Interval 65.0 to 99.0
|
—
|
—
|
Adverse Events
Single Arm
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Single Arm
n=18 participants at risk
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 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.
|
|---|---|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
22.2%
4/18 • 5 years
|
|
Investigations
Alkaline phosphatase
|
22.2%
4/18 • 5 years
|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
5.6%
1/18 • 5 years
|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
11.1%
2/18 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Apnea
|
5.6%
1/18 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis (non-septic)
|
5.6%
1/18 • 5 years
|
|
Metabolism and nutrition disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
5.6%
1/18 • 5 years
|
|
Metabolism and nutrition disorders
Bicarbonate, serum-low
|
5.6%
1/18 • 5 years
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
5.6%
1/18 • 5 years
|
|
Renal and urinary disorders
Bladder spasms
|
5.6%
1/18 • 5 years
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow - Other (Specify, __)
|
5.6%
1/18 • 5 years
|
|
Metabolism and nutrition disorders
Calcium, serum-high (hypercalcemia)
|
5.6%
1/18 • 5 years
|
|
Metabolism and nutrition disorders
Cholesterol, serum-high (hypercholesteremia)
|
5.6%
1/18 • 5 years
|
|
Gastrointestinal disorders
Constipation
|
33.3%
6/18 • 5 years
|
|
General disorders
Constitutional Symptoms (Other, specify)
|
5.6%
1/18 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.1%
2/18 • 5 years
|
|
Metabolism and nutrition disorders
Creatinine
|
5.6%
1/18 • 5 years
|
|
Immune system disorders
Cytokine release syndrome/acute infusion reaction
|
5.6%
1/18 • 5 years
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, __)
|
16.7%
3/18 • 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
44.4%
8/18 • 5 years
|
|
Gastrointestinal disorders
Distension/bloating, abdominal
|
16.7%
3/18 • 5 years
|
|
Nervous system disorders
Dizziness
|
22.2%
4/18 • 5 years
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
5.6%
1/18 • 5 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.6%
1/18 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
27.8%
5/18 • 5 years
|
|
General disorders
Edema: head and neck
|
5.6%
1/18 • 5 years
|
|
General disorders
Edema: limb
|
5.6%
1/18 • 5 years
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
5.6%
1/18 • 5 years
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
61.1%
11/18 • 5 years
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
5.6%
1/18 • 5 years
|
|
Gastrointestinal disorders
Flatulence
|
5.6%
1/18 • 5 years
|
|
General disorders
Flu-like syndrome
|
5.6%
1/18 • 5 years
|
|
Gastrointestinal disorders
Gastrointestinal - Other (Specify, __)
|
5.6%
1/18 • 5 years
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
38.9%
7/18 • 5 years
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
11.1%
2/18 • 5 years
|
|
Blood and lymphatic system disorders
Hemoglobin
|
66.7%
12/18 • 5 years
|
|
Gastrointestinal disorders
Hemorrhage, GI - Abdomen NOS
|
5.6%
1/18 • 5 years
|
|
Gastrointestinal disorders
Hemorrhoids
|
16.7%
3/18 • 5 years
|
|
Endocrine disorders
Hot flashes/flushes
|
55.6%
10/18 • 5 years
|
|
Cardiac disorders
Hypertension
|
27.8%
5/18 • 5 years
|
|
Gastrointestinal disorders
Incontinence, anal
|
5.6%
1/18 • 5 years
|
|
Infections and infestations
Infection - Other (Specify, __)
|
5.6%
1/18 • 5 years
|
|
Psychiatric disorders
Insomnia
|
38.9%
7/18 • 5 years
|
|
Investigations
Leukocytes (total WBC)
|
22.2%
4/18 • 5 years
|
|
Reproductive system and breast disorders
Libido
|
5.6%
1/18 • 5 years
|
|
Investigations
Lymphopenia
|
66.7%
12/18 • 5 years
|
|
Metabolism and nutrition disorders
Magnesium, serum-high (hypermagnesemia)
|
27.8%
5/18 • 5 years
|
|
Psychiatric disorders
Mood alteration - Anxiety
|
11.1%
2/18 • 5 years
|
|
Psychiatric disorders
Mood alteration - Depression
|
5.6%
1/18 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other (Specify, __)
|
11.1%
2/18 • 5 years
|
|
Gastrointestinal disorders
Nausea
|
33.3%
6/18 • 5 years
|
|
Nervous system disorders
Neuropathy: sensory
|
16.7%
3/18 • 5 years
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
11.1%
2/18 • 5 years
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
5.6%
1/18 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
11.1%
2/18 • 5 years
|
|
Renal and urinary disorders
Pain - Bladder
|
5.6%
1/18 • 5 years
|
|
Cardiac disorders
Pain - Chest/thorax NOS
|
5.6%
1/18 • 5 years
|
|
Nervous system disorders
Pain - Head/headache
|
16.7%
3/18 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Joint
|
5.6%
1/18 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Neck
|
5.6%
1/18 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Other (Specify, __)
|
5.6%
1/18 • 5 years
|
|
Reproductive system and breast disorders
Pain - Penis
|
5.6%
1/18 • 5 years
|
|
Gastrointestinal disorders
Pain - Rectum
|
5.6%
1/18 • 5 years
|
|
Gastrointestinal disorders
Pain - Stomach
|
5.6%
1/18 • 5 years
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
5.6%
1/18 • 5 years
|
|
Investigations
Platelets
|
33.3%
6/18 • 5 years
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
11.1%
2/18 • 5 years
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
5.6%
1/18 • 5 years
|
|
Gastrointestinal disorders
Proctitis
|
5.6%
1/18 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (Specify, __)
|
11.1%
2/18 • 5 years
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
22.2%
4/18 • 5 years
|
|
Renal and urinary disorders
Renal/Genitourinary - Other (Specify, __)
|
33.3%
6/18 • 5 years
|
|
Skin and subcutaneous tissue disorders
Skin breakdown/decubitus ulcer
|
5.6%
1/18 • 5 years
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
5.6%
1/18 • 5 years
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia - Sinus tachycardia
|
5.6%
1/18 • 5 years
|
|
Nervous system disorders
Taste alteration (dysgeusia)
|
11.1%
2/18 • 5 years
|
|
Metabolism and nutrition disorders
Triglyceride, serum-high (hypertriglyceridemia)
|
5.6%
1/18 • 5 years
|
|
Gastrointestinal disorders
Ulcer, GI - Anus
|
5.6%
1/18 • 5 years
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
77.8%
14/18 • 5 years
|
|
Renal and urinary disorders
Urinary retention (including neurogenic bladder)
|
11.1%
2/18 • 5 years
|
|
Nervous system disorders
Vasovagal episode
|
5.6%
1/18 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)
|
5.6%
1/18 • 5 years
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
1/18 • 5 years
|
|
Investigations
Weight gain
|
11.1%
2/18 • 5 years
|
Additional Information
Robin V. Johnson
Lineberger Comprehensive Cancer Center
Phone: 919-966-1125
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60