Condition category
Cancer
Date applied
06/02/2012
Date assigned
06/02/2012
Last edited
26/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

http://www.enherts-tr.nhs.uk/our-hospitals/lister/

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

Publication citations

Additional files

Editorial Notes

25/02/2016: No publications found, verifying study status with principal investigator.