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Docetaxel, Androgen Ablation, and External-Beam Radiation Therapy in Patients With High-Risk Localized Prostate Cancer (NRR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00225420
Recruitment Status : Completed
First Posted : September 23, 2005
Results First Posted : June 1, 2017
Last Update Posted : June 1, 2017
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

Tracking Information
First Submitted Date  ICMJE September 21, 2005
First Posted Date  ICMJE September 23, 2005
Results First Submitted Date  ICMJE March 9, 2017
Results First Posted Date  ICMJE June 1, 2017
Last Update Posted Date June 1, 2017
Study Start Date  ICMJE August 2005
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 26, 2017)
Number of Patients Experiencing Dose-Limiting Toxicities [ Time Frame: Average follow up of 2 years ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 21, 2005)
determine the maximum tolerated dose of docetaxel when given in combination with high-dose external beam when given with radiation therapy, and androgen ablation
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2017)
Biochemical Progression-free Survival (PFS) [ Time Frame: Average follow up of 2 years ]
Measure 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2005)
2-year biochemical progression-free survival
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Docetaxel, Androgen Ablation, and External-Beam Radiation Therapy in Patients With High-Risk Localized Prostate Cancer
Official Title  ICMJE A Phase I/II Study of Concurrent Weekly Docetaxel (Taxotere®), Androgen Ablation, and Adaptive External Beam Radiotherapy for Localized High-Risk Adenocarcinoma of the Prostate
Brief Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as leuprolide, may lessen the amount of androgens made by the body. Radiation therapy uses high energy x-rays to kill tumor cells. Giving docetaxel together with androgen ablation therapy and external-beam radiation therapy may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of docetaxel when given together with androgen ablation therapy and external-beam radiation therapy and to see how well they work in treating patients with high-risk localized prostate cancer.

Detailed Description



  • Determine the dose-limiting toxicity and maximum tolerated dose of docetaxel when administered in combination with androgen ablation therapy and adaptive external-beam radiotherapy in patients with high-risk localized adenocarcinoma of the prostate.


  • Determine the 2-year biochemical progression-free survival of patients treated with this regimen.

OUTLINE: This is a multicenter, open-label, dose-escalation study of docetaxel.

  • Androgen ablation therapy: Patients receive leuprolide acetate or other luteinizing hormone-releasing hormone agonist beginning 2-3 months prior to the start of chemoradiotherapy and continuing for up to 2 years.
  • Chemoradiotherapy: Patients receive docetaxel IV over 1 hour on day 1 and high-dose external-beam radiotherapy on days 1-5. Treatment repeats every 7 days for 8 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of docetaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

After completion of study treatment, patients are followed every 3 months.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Drug: 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.
    Other Name: Taxotere
  • Drug: 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.
    Other Names:
    • Lupron
    • Eligard
    • Viadur
    • Zoladex
  • Radiation: radiation therapy
    The total dose will be 7800 cGy in 200 centigray (cGy) per fraction for a total of 39 treatments.
Study Arms  ICMJE Single Arm Intervention
Single Arm Intervention where after enrollment (or prior to enrollment but before starting radiotherapy) patients will initially receive leuprolide acetate (Lupron®) intramuscular (IM). Patients will begin adaptive external-beam radiation therapy 2-3 months following the initiation of hormonal therapy. Each patient receives a dose of docetaxel at 10 mg/m2 intravenously over 1 hour weekly for eight weeks, for a total of eight weeks.
  • Drug: docetaxel
  • Drug: leuprolide acetate
  • Radiation: radiation therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 10, 2012)
Original Enrollment  ICMJE
 (submitted: September 21, 2005)
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Histologically confirmed adenocarcinoma of the prostate with any of following clinical features:

    A) T3 or T4 B) T1-2 + Gleason Score 8-10 C) T1-2 + Gleason Score 7 + Prostate Specific Antigen (PSA) >10 ng/mL D) T1-2 + Any Gleason Score + PSA >20 ng/mL

  2. No evidence of metastatic disease on chest x-ray, bone scan or CT scan of abdomen/pelvis.
  3. Age > 18
  4. The Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
  5. Peripheral neuropathy: must be < grade 1
  6. Hematologic parameters A) Absolute neutrophil count > 1,500/mm3 B) Hemoglobin > 8.0 g/dL C) Platelet count > 100,000/mm3.
  7. Hepatic parameters / Renal function A) Total Bilirubin must be ≤ 1.2 mg/dL B) Transaminases (AST and ALT) must be < 1.5 x upper limit of normal (ULN) C) Alkaline phosphatase must be < 2.5 x ULN D) Creatinine < 1.5 x ULN ( < 2.1 mg/dL)
  8. No prior pelvic or prostate radiation or chemotherapy for prostate cancer. Androgen ablation therapy with one of the luteinizing hormone-releasing hormone (LH-RH) agonists prior to enrollment is acceptable as long as protocol treatment with radiotherapy and chemotherapy is started within 3 months of the initiation of androgen ablation.
  9. Patient must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.

Exclusion Criteria:

  1. Documented metastases on staging studies
  2. Life expectancy <10 years secondary to co-morbid illness
  3. Myocardial infarction or significant change in anginal pattern within one year prior to study entry or current congestive heart failure (New York Heart Association Class 2 or higher)
  4. Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
  5. History of invasive malignancy within the last five years prior to study entry except for carcinoma in situ or nonmelanoma skin cancer.
  6. Psychiatric conditions which would prevent compliance with treatment or adequate informed consent.
  7. Patients receiving another investigational agent during chemo- and radiotherapy
  8. Uncontrolled intercurrent illness or other conditions that limit compliance with protocol treatment
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00225420
Other Study ID Numbers  ICMJE LCCC 0420
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party UNC Lineberger Comprehensive Cancer Center
Study Sponsor  ICMJE UNC Lineberger Comprehensive Cancer Center
Collaborators  ICMJE Sanofi
Investigators  ICMJE
Principal Investigator: Young Whang, MD, PhD UNC Lineberger Comprehensive Cancer Center
PRS Account UNC Lineberger Comprehensive Cancer Center
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP