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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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8 August 2016 |
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Main ID: |
NCT00003734 |
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Date of registration:
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01/11/1999 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Combination Hormone Therapy Followed by Radiation Therapy in Treating Patients With Prostate Cancer
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Scientific title:
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A Randomised Comparison of Short and Protracted Neoadjuvant Hormonal Therapy Prior to Radiation Therapy of High Risk Localized Prostate Cancer |
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Date of first enrolment:
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December 1998 |
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Target sample size:
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276 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT00003734 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Ireland
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United Kingdom
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Contacts
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Name:
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John Gerard Armstrong, MD, MB, MRCPI |
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Address:
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Telephone:
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Email:
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Affiliation:
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Saint Luke's Hospital |
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Key inclusion & exclusion criteria
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DISEASE CHARACTERISTICS: Histologically confirmed invasive adenocarcinoma of the prostate
Stage I or II (PSA greater than 20 or Gleason score at least 7) OR Stage III or IV (any
PSA, any Gleason) Histologically confirmed benign nodal status No distant metastases
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life
expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not
specified Other: No other prior malignancy except nonmelanoma skin cancer No other
uncontrolled illness that would prevent compliance
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified
Endocrine therapy: No prior or other concurrent hormonal therapy Radiotherapy: Not
specified Surgery: No prior treatment other than transurethral prostatectomy No prior
orchiectomy
Age minimum:
18 Years
Age maximum:
120 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Prostate Cancer
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Intervention(s)
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Drug: triptorelin
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Drug: flutamide
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Radiation: radiation therapy
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Secondary ID(s)
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EU-98060
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ICORG-97-01
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CDR0000066849
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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