The ELDORADO (Eligard®, Docetaxel and Radiotherapy) Study

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

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, Senior
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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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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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