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ISRCTN
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ISRCTN08912168
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ClinicalTrials.gov identifier
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Public title
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A trial of PROstate radiotherapy in CONjunction with carbogen and nicotinamide (PROCON)
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Scientific title
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A trial of Prostate Radiotherapy in Conjunction with Carbogen and Nicotinamide
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Acronym
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PROCON
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Serial number at source
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9930
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Study hypothesis
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To investigate the use of carbogen and nicotinamide during a course radiotherapy for locally advanced prostate cancer to overcome tumour hypoxia.
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Lay summary
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http://cancerhelp.cancerresearchuk.org/trials/a-study-looking-radiotherapy-with-carbogen-and-nicotinamide-prostate-cancer-procon
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Ethics approval
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ref: 11/SC/0064
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Study design
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Non-randomised interventional trial
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Countries of recruitment
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United Kingdom
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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 prostate adenocarcinoma of Gleason grade 3+3 or higher
2. Radical radiotherapy is considered to be appropriate treatment
3. Any of: PSA > 20ng/ml, Gleason grade > 8, T3 disease on MRI
4. Patients must have radiographically documented measurable disease on pelvic MRI scan within 3 months of trial entry
5. Age over 18 with no upper age limit
6. Before patient registration, written informed consent must be given according to GCP and local regulations.
7. Male participants
8. Lower Age Limit 18 years
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Participants - exclusion criteria
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1. Metastatic disease (including pelvic lymph node metastases) on conventional imaging including pelvic MRI scan and isotope bone scan within 3 months of trial entry
2. PSA>50
3. T4 disease on pelvic MRI scan within 3 months of trial entry
4. Prior treatment for prostate cancer, either local or systemic (other than neoadjuvant androgen deprivation for a period of less than 3 months)
5. Current active malignancy other than prostate cancer or nonmelanomatous skin cancer
6. Previous radiotherapy to the pelvis
7. Comorbid conditions such that the technique of external beam radiotherapy is inappropriate
8. Contraindication to MRI (only applicable to patients that are being considered for entry into the imaging component of the study)
9. Current treatment with an ACE inhibitor
10. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and followup schedule; those conditions should be discussed with the patient before registration in the trial
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Anticipated start date
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16/12/2011
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Anticipated end date
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01/09/2013
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Status of trial
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Ongoing |
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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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Planned Sample Size: 50; UK Sample Size: 50
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Interventions
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Carbogen & Nicotinamide, The use of carbogen and nicotinamide during radiotherapy.
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Primary outcome measure(s)
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PSA progression free survival measured at 5 years
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Secondary outcome measure(s)
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Short term and long term GU & GI toxicity following treatment.
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Sources of funding
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Prostate Cancer Charity (UK)
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Trial website
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Publications
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Contact name
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Dr
Kent
Yip
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Address
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Marie Curie Research Wing
Mount Vernon Hospital
Rickmansworth Road
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City/town
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Northwood
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Zip/Postcode
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HA6 2RN
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Country
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United Kingdom
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Email
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kent.yip@nhs.net
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Sponsor
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East and North Hertfordshire Hospitals NHS Trust (UK)
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Address
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Lister Hospital
Coreys Mill Lane
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City/town
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Stevenage
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Zip/Postcode
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SG1 4AB
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Country
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United Kingdom
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Tel
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+44 (0)1438 314333
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Email
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Sponsor website:
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http://www.enherts-tr.nhs.uk/our-hospitals/lister/
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Date applied
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06/02/2012
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Last edited
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15/05/2012
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Date ISRCTN assigned
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06/02/2012
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