A trial of prostate radiotherapy in conjunction with carbogen and nicotinamide

ISRCTN	ISRCTN08912168
DOI	https://doi.org/10.1186/ISRCTN08912168
EudraCT/CTIS number	2010-021886-63
Secondary identifying numbers	9930

Submission date: 06/02/2012
Registration date: 06/02/2012
Last edited: 15/09/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

http://cancerhelp.cancerresearchuk.org/trials/a-study-looking-radiotherapy-with-carbogen-and-nicotinamide-prostate-cancer-procon

Contact information

Dr Kent Yip
Scientific

Marie Curie Research Wing
Mount Vernon Hospital
Rickmansworth Road
Northwood
HA6 2RN
United Kingdom

Email	kent.yip@nhs.net

Study information

Study design	Non-randomised interventional trial
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A trial of PROstate radiotherapy in CONjunction with carbogen and nicotinamide (PROCON)
Study 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(s)	ref: 11/SC/0064
Condition	Prostate cancer
Intervention	The use of carbogen and nicotinamide during radiotherapy.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Phase II
Drug / device / biological / vaccine name(s)	Carbogen, nicotinamide
Primary outcome measure	PSA progression-free survival measured at 5 years
Secondary outcome measures	Short-term and long-term GU and GI toxicity following treatment
Overall study start date	16/12/2011
Overall study end date	01/09/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Male
Target number of participants	Planned Sample Size: 50; UK Sample Size: 50
Total final enrolment	50
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 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

England
United Kingdom

Study participating centre

Mount Vernon Hospital

Northwood
HA6 2RN
United Kingdom

Sponsor information

East and North Hertfordshire Hospitals NHS Trust (UK)
Hospital/treatment centre

Lister Hospital
Coreys Mill Lane
Stevenage
SG1 4AB
England
United Kingdom

Phone	+44 (0)1438 314333
Email	abc@email.com
Website	http://www.enherts-tr.nhs.uk/our-hospitals/lister/
"ROR"	https://ror.org/02ryc4y44

Funders

Funder type

Charity

Prostate Cancer Charity (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Plain English results			15/09/2022	No	Yes
HRA research summary			28/06/2023	No	No

Editorial Notes

15/09/2022: Cancer Research UK plain English results link and total final enrolment added.
25/02/2016: No publications found, verifying study status with principal investigator.