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ISRCTN
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ISRCTN24991896
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DOI
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10.1186/ISRCTN24991896
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ClinicalTrials.gov identifier
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NCT00002633
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EudraCT number
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Public title
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A randomised clinical trial of hormones plus radiotherapy vs hormone therapy alone in non-metastatic prostate cancer
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Scientific title
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Acronym
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N/A
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Serial number at source
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G9805643 (PR07)
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Study hypothesis
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To evaluate any possible benefit from the addition of external beam radiation therapy to the treatment of patients with non-metastatic prostate cancer who have not had a radical prostatectomy and are receiving hormonal therapy.
More details can be found at: http://www.ctu.mrc.ac.uk/research_areas/study_details.aspx?s=58
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Lay summary
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http://cancerhelp.cancerresearchuk.org/trials/a-trial-looking-at-hormone-therapy-with-or-without-radiotherapy-in-advanced-prostate-cancer
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Ethics approval
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Not provided at time of registration.
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom, United States of America
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Disease/condition/study domain
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Prostate cancer
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Participants - inclusion criteria
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1. Histological diagnosis of adenocarcinoma of the prostate within 6 months of randomisation
2. Either (a) clinical stage T3 or T4, NO or NX, MO or (b) clinical stage T2, NO or NX, MO with Prostate-Specific Antigen (PSA) greater than 40 or (c) clinical stage T2, NO or NX, MO with PSA greater than 20 and Gleason sum score greater than or equal to 8
3. The patient must have a bone scan (with X-rays of any areas of abnormal uptake) reported as being free of evidence of bony metastases within 16 weeks prior to randomisation (if not already on hormones) or 16 weeks prior to the start of hormones (if on hormones already)
4. No previous treatment for prostate cancer apart from transurethral resection. However, the patient may have received prior hormone therapy during the 12 weeks prior to randomisation, provided that (a) a negative bone scan was demonstrated, preferably within the 16 weeks prior to starting hormone therapy but certainly within 2 weeks after starting hormone therapy and (b) baseline PSA within 4 weeks prior to hormone therapy is available
5. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
6. Patients must be less than 80 years old
7. Written informed consent
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Participants - exclusion criteria
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1. A history of previous or concurrent malignancy other than non-melanomatous skin cancer within 5 years of diagnosis of the prostatic cancer.
2. The presence of small-cell or transitional-cell carcinoma in the biopsy specimen.
3. Any contraindication to pelvic radiotherapy (e.g. inflammatory bowel disease).
4. Any serious non-malignant disease resulting in a life expectancy of less than 5 years.
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Anticipated start date
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01/06/1999
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Anticipated end date
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31/08/2005
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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1,200
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Interventions
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All patients will receive hormonal manipulation.
Patients are randomised to receive:
1. Additional radiotherapy (65-69Gy/35-37f)
2. No additional radiotherapy.
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Primary outcome measure(s)
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Overall survival
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Secondary outcome measure(s)
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1. Time to disease progression
2. Symptomatic local control measured by the rates of surgical interventions necessary for symptomatic local disease (I.e. the combined incidences of TURPs, stent insertions, nephrostomies and colostomies)
3. Quality of Life measured by the FACT-P questionnaire
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Sources of funding
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Medical Research Council (UK)
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Trial website
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Publications
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1. 2000 study protocol in http://www.ncbi.nlm.nih.gov/pubmed/11005685
2. 2005 appraisal in http://www.ncbi.nlm.nih.gov/pubmed/15997913
3. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22056152
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Contact name
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Prof
MK
Parmar
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Address
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MRC Clinical Trials Unit
222 Euston Road
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City/town
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London
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Zip/Postcode
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NW1 2DA
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Country
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United Kingdom
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Email
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Sponsor
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Medical Research Council (MRC) Clinical Trials Unit - Cancer Division (UK)
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Address
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222 Euston Road
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City/town
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London
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Zip/Postcode
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NW1 2DA
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Country
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United Kingdom
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Email
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Sponsor website:
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http://www.ctu.mrc.ac.uk/
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Date applied
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06/04/2000
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Last edited
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12/04/2012
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Date ISRCTN assigned
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06/04/2000
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