Prostate Cancer MedDRA version: 14.0 Level: PT Classification code 10060862 Term: Prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: NICOBION
Product Name: NICOBION
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Nicotinamide(pyridine 3-carboxamide)
Sponsors
East and North Hertfordshire NHS Trust
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: •Histological diagnosis of prostate adenocarcinoma of Gleason grade 3+3 or higher •Radical radiotherapy is considered to be appropriate treatment •Any of: PSA > 20ng/ml, Gleason grade > 8, T3 disease on MRI •Patients must have radiographically documented measurable disease on pelvic MRI scan within 3 months of trial entry •Age over 18 with no upper age limit •Before patient registration, written informed consent must be given according to GCP and local regulations. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: •Metastatic disease (including pelvic lymph node metastases) on conventional imaging including pelvic MRI scan and isotope bone scan within 3 months of trial entry •PSA>50 •T4 disease on pelvic MRI scan within 3 months of trial entry •Prior treatment for prostate cancer, either local or systemic (other than neo-adjuvant androgen deprivation for a period of less than 3 months) •Current active malignancy other than prostate cancer or non-melanomatous skin cancer •Previous radiotherapy to the pelvis •Co-morbid conditions such that the technique of external beam radiotherapy is inappropriate •Contraindication to MRI (only applicable to patients that are being considered for entry into the imaging component of the study) •Current treatment with an ACE inhibitor •Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Patients will be assessed for biochemical relapse at 2, 4, 12 and 26 weeks after treatment by using a serum PSA blood test. Thereafter they will be assessed at six monthly intervals for a total of five years.; Main Objective: Primary objective We propose a study to test whether it is possible to improve the outcome of prostate radiotherapy using simple, cost-effective measures. Carbogen gas (98% oxygen and 2% carbon dioxide) and nicotinamide (vitamin B3) will be given in conjunction with standard prostate radiotherapy. Disease control, survival and toxicity will be measured. The study aims to determine the efficacy of carbogen gas breathing and nicotinamide tablets, given during a course of intensity-modulated radiotherapy to the prostate gland in previously untreated patients with prostate cancer. ; Secondary Objective: Secondary Objectives To describe the toxic effects of the combination of prostate radiotherapy with carbogen and nicotinamide. To describe the time to progression, the proportion achieving PSA control following radiotherapy, the local control rate and overall survival. Imaging research will explore: (1) Whether hypoxia modification benefits tumours previously treated with hormones to an even greater extent that hormone-naive cancers. (2) The way radiotherapy alters the extent and distribution of oxygen within prostate tumours, which will be important for the development of biologically-targeted radiotherapy. (3) Whether imaging studies can predict which patients may benefit most from hypoxic modification. Laboratory research will attempt to determine whether markers of tumour oxygen levels derived from special stains of prostate tissue can be used to determine prognosis following radiotherapy for prostate cancer and which patients may benefit from hypoxia modification. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints are: Overall relapse-free survival Overall survival Safety profile (as measured by CTCAEv4.0) Quality of life (as measured by IPSS, FACT-P, IIEF-5 and drug use) ;Timepoint(s) of evaluation of this end point: Patients will be assessed for these end points at 2, 4, 12 and 26 weeks after treatment. Thereafter they will be assessed at six monthly intervals for a total of five years. | — |
Countries
United Kingdom
Outcome results
None listed