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

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 |

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
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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
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Experimental: Experimental Radiotherapy Sequence Arm
Experimental sequence of radiotherapy = whole pelvic lymphatics, proximal seminal vesicles, prostate (or prostate bed) last, prostate/prostate bed first
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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
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- 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 ]
- 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 ]
- total amount of Docetaxel that can be delivered [ Time Frame: 3 years ]
- quality of life in patients receiving concurrent, weekly Docetaxel chemotherapy, in concert with long - term androgen deprivation (LTAD). [ Time Frame: 3 years ]

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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.
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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.
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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.
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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).

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
Canada, Nova Scotia | |
Nova Scotia Cancer Centre | |
Halifax, Nova Scotia, Canada, B3H 1V7 |
Principal Investigator: | Derek R Wilke, MD,MSc,FRCPC | Nova Scotia Cancer Centre, Department of Radiation Oncology, Dalhousie University |
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 |