A trial of prostate radiotherapy in conjunction with carbogen and nicotinamide
| ISRCTN | ISRCTN08912168 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN08912168 |
| Clinical Trials Information System (CTIS) | 2010-021886-63 |
| Protocol serial number | 9930 |
| Sponsor | East and North Hertfordshire Hospitals NHS Trust (UK) |
| Funder | Prostate Cancer Charity (UK) |
- 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 of protocol
Contact information
Dr Kent Yip
Scientific
Scientific
Marie Curie Research Wing
Mount Vernon Hospital
Rickmansworth Road
Northwood
HA6 2RN
United Kingdom
| kent.yip@nhs.net |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Non-randomised interventional trial |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | A trial of PROstate radiotherapy in CONjunction with carbogen and nicotinamide (PROCON) |
| Study acronym | PROCON |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | Prostate cancer |
| Intervention | The use of carbogen and nicotinamide during radiotherapy. |
| Intervention type | Drug |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Carbogen, nicotinamide |
| Primary outcome measure(s) |
PSA progression-free survival measured at 5 years |
| Key secondary outcome measure(s) |
Short-term and long-term GU and GI toxicity following treatment |
| Completion date | 01/09/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target sample size at registration | 50 |
| Total final enrolment | 50 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 16/12/2011 |
| Date of final enrolment | 01/09/2013 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Mount Vernon Hospital
Northwood
HA6 2RN
United Kingdom
HA6 2RN
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Plain English results | 15/09/2022 | No | Yes |
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.
