Plain English Summary
Trial website
Contact information
Type
Scientific
Primary contact
Dr Kent Yip
ORCID ID
Contact details
Marie Curie Research Wing
Mount Vernon Hospital
Rickmansworth Road
Northwood
HA6 2RN
United Kingdom
-
kent.yip@nhs.net
Additional identifiers
EudraCT number
2010-021886-63
ClinicalTrials.gov number
Protocol/serial number
9930
Study information
Scientific title
A trial of PROstate radiotherapy in CONjunction with carbogen and nicotinamide (PROCON)
Acronym
PROCON
Study hypothesis
To investigate the use of carbogen and nicotinamide during a course radiotherapy for locally advanced prostate cancer to overcome tumour hypoxia.
Ethics approval
ref: 11/SC/0064
Study design
Non-randomised interventional trial
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Prostate cancer
Intervention
The use of carbogen and nicotinamide during radiotherapy.
Intervention type
Drug
Phase
Phase II
Drug names
Carbogen, nicotinamide
Primary outcome measures
PSA progression-free survival measured at 5 years
Secondary outcome measures
Short-term and long-term GU and GI toxicity following treatment
Overall trial start date
16/12/2011
Overall trial end date
01/09/2013
Reason abandoned
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
Planned Sample Size: 50; UK Sample Size: 50
Participant exclusion criteria
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
Recruitment start date
16/12/2011
Recruitment end date
01/09/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Mount Vernon Hospital
Northwood
HA6 2RN
United Kingdom
Sponsor information
Organisation
East and North Hertfordshire Hospitals NHS Trust (UK)
Sponsor details
Lister Hospital
Coreys Mill Lane
Stevenage
SG1 4AB
United Kingdom
+44 (0)1438 314333
abc@email.com
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
Prostate Cancer Charity (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary