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The ELDORADO (Eligard®, Docetaxel and Radiotherapy) Study

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ClinicalTrials.gov Identifier: NCT00452556
Recruitment Status : Unknown
Verified March 2014 by Derek R Wilke MD,MSc,FRCPC, Queen Elizabeth II Health Sciences Centre.
Recruitment status was:  Active, not recruiting
First Posted : March 27, 2007
Last Update Posted : March 19, 2014
Sponsor:
Information provided by (Responsible Party):
Derek R Wilke MD,MSc,FRCPC, Queen Elizabeth II Health Sciences Centre

Study Description
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Brief Summary:
The purpose of this study is to see if sequence inversion of Intensity - modulated Radiotherapy (IMRT) for prostate cancer, can improve the safety and deliverability of concurrent docetaxel chemotherapy with long - term hormonal therapy. The hypothesis is that inverting the traditional sequence of radiotherapy can delay the time to treatment - induced bowel toxicity.

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Drug: Docetaxel Drug: Leuprolide Acetate (Eligard®) Radiation: Intensity-Modulated Radiotherapy Phase 2

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The ELDORADO (Eligard®, Docetaxel and Radiotherapy) Study: A Phase II Study of Chemo - Hormonal Therapy and Radiation in High Risk Prostate Cancer
Study Start Date : May 2007
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Standard Radiotherapy Sequence Arm
Standard sequence of radiotherapy = whole pelvic lymphatics, proximal seminal vesicles, prostate (or prostate bed) first, then prostate/prostate bed last
 Drug: Docetaxel
Weekly
Other Name: Taxotere

Drug: Leuprolide Acetate (Eligard®)
2.5 years
Other Name: Androgen deprivation

Radiation: Intensity-Modulated Radiotherapy
Standard sequence = irradiation of pelvic lymphatics, seminal vesicles, and prostate, followed by irradiation of gross tumor (prostate+extraprostatic extension, as determined by MRI)
Other Name: Radiotherapy

Radiation: Intensity-Modulated Radiotherapy
Experimental sequence = irradiation of pelvic lymphatics, seminal vesicles, and prostate last, irradiation of gross tumor (prostate+extraprostatic extension, as determined by MRI)first
Other Name: Radiotherapy
Experimental: Experimental Radiotherapy Sequence Arm
Experimental sequence of radiotherapy = whole pelvic lymphatics, proximal seminal vesicles, prostate (or prostate bed) last, prostate/prostate bed first
 Drug: Docetaxel
Weekly
Other Name: Taxotere

Drug: Leuprolide Acetate (Eligard®)
2.5 years
Other Name: Androgen deprivation

Radiation: Intensity-Modulated Radiotherapy
Standard sequence = irradiation of pelvic lymphatics, seminal vesicles, and prostate, followed by irradiation of gross tumor (prostate+extraprostatic extension, as determined by MRI)
Other Name: Radiotherapy

Radiation: Intensity-Modulated Radiotherapy
Experimental sequence = irradiation of pelvic lymphatics, seminal vesicles, and prostate last, irradiation of gross tumor (prostate+extraprostatic extension, as determined by MRI)first
Other Name: Radiotherapy


Outcome Measures
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Primary Outcome Measures :
  1. To investigate if the inversion of sequencing of multi - phase, intensity - modulated radiotherapy (IMRT), for the treatment of patients with high - risk prostate cancer, can improve the delivery of concurrent, weekly Docetaxel chemotherapy, in conc [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. To investigate if the inversion of sequencing of multi - phase IMRT can improve the time to grade 2 or 3 gastrointestinal toxicity. [ Time Frame: 3 years ]
  2. total amount of Docetaxel that can be delivered [ Time Frame: 3 years ]
  3. quality of life in patients receiving concurrent, weekly Docetaxel chemotherapy, in concert with long - term androgen deprivation (LTAD). [ Time Frame: 3 years ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A histological diagnosis of adenocarcinoma of the prostate
  • Life expectancy greater than 5 years.
  • ECOG performance status < 1.
  • Signed, written informed consent prior to randomization.

  • Any one, or more, of the following criteria:

    • TNM stage T2c, T3a or T3b
    • Gleason score 8 to 10, as determined by central institutional review.
    • PSA > 20 mcg/L, but < 50 mcg/L. OR Have a > 50% chance of recurrence after radical prostatectomy, as predicted by the Kattan Nomogram and
    • Post - op PSA < 1.0 mcg/L.
    • Must be able to start protocol treatment within 6 months from date of surgery.
  • No evidence of metastasis, as determined by bone scan and Chest x-ray/CT abdomen/pelvis.

  • Adequate marrow reserve and end - organ function

    • Leukocytes > 3,000/mcL.
    • Absolute neutrophil count > 1,500/mcL
    • Platelets > 100,000/mcL
    • Total bilirubin < 1.2 x upper limit of normal for the institution.
    • AST(SGOT)/ALT(SGPT) greater than 1.5 X institutional upper limit of normal
    • Creatinine within normal institutional limits OR
    • Creatinine clearance > 60 mL/min using the Crockfort - Gault formula for patients with creatinine levels above institutional normal.

Exclusion Criteria:

  • PSA > 50 µg/L.
  • Previous pelvic radiotherapy
  • Sensitivity to Docetaxel chemotherapy.
  • Grade 2 or greater NCI CTCAE version 3.0 neuropathy.

  • Prior malignancy within the last 5 years, other than prostate cancer, except:

    • Patients with adequately treated non - melanoma cutaneous malignancies.
    • Patients with a history of a curatively treated malignancy (including patients with superficial bladder cancer) who have not had evidence of recurrence for a minimum of 5 years.
  • Patients with a history of hypersensitivity to polysorbate 80.
  • Patients with a known history of viral hepatitis (B,C).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00452556


Locations
Canada, Nova Scotia
Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada, B3H 1V7
Sponsors and Collaborators
Nova Scotia Cancer Centre
Investigators
Principal Investigator: Derek R Wilke, MD,MSc,FRCPC Nova Scotia Cancer Centre, Department of Radiation Oncology, Dalhousie University
More Information
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Responsible Party: Derek R Wilke MD,MSc,FRCPC, Research Director, Department of Radiation Oncology, Queen Elizabeth II Health Sciences Centre
ClinicalTrials.gov Identifier: NCT00452556     History of Changes
Other Study ID Numbers: DOCET-L-01892
First Posted: March 27, 2007    Key Record Dates
Last Update Posted: March 19, 2014
Last Verified: March 2014

Keywords provided by Derek R Wilke MD,MSc,FRCPC, Queen Elizabeth II Health Sciences Centre:
Prostatic Neoplasms
Radiotherapy
Docetaxel
Leuprolide Acetate

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Genital Diseases, Male
Docetaxel
Leuprolide
Antineoplastic Agents
 Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal