Dose EscaLation to Intraprostatic tumour Nodules in localisEd prostATE cancer: A phase II study examining the toxicity and feasibility of a dose escalated boost to a magnetic resonance imaging identified tumour nodule or nodules in localised prostate cancer

Recruiting

• Source

  -

  Public Title	Dose EscaLation to Intraprostatic tumour Nodules in localisEd prostATE cancer: A phase II study examining the toxicity and feasibility of a dose escalated boost to a magnetic resonance imaging identified tumour nodule or nodules in localised prostate cancer
  Acronym	DELINEATE
  Source of Record URL	http://isrctn.org/ISRCTN04483921

• Trial

  -

  Health Condition(s) or Problem	Topic: National Cancer Research Network; Subtopic: Prostate Cancer; Disease: Prostate
  Lay Summary	Dose Escalation to Intra-prostatic Tumour Nodules in Localised Prostate Cancer Dose Escalation to Intra-prostatic Tumour Nodules in Localised Prostate Cancer To assess the toxicity and feasibility of a dose escalated intensity-modulated radiotherapy boost to tumour nodules within the prostate using anatomical and functional MR imaging to identify tumour. The aim is to maintain current levels of late toxicity. (from UKCRN Portfolio) Additional lay summaries... http://cancerhelp.cancerresearchuk.org/trials/a-study-looking-at-increasing-dose-of-radiotherapy-to-areas-of-cancer-inside-prostate-gland-delineate (from ISRCTN)
  Who can enter the trial	1. Age more than or equal to 18 years 2. Histologically confirmed adenocarcinoma of the prostate 3. National Collaborative Cancer Network+ (NCCN) risk groups intermediate or high risk localised prostate cancer 4. Normal blood count [haemoglobin (Hb) > 11g/dl, white blood cell (WBC) > 4000/mm³, platelets > 100,000/mm³] 5. World Health Organisation (WHO) performance status 0 or 1 6. Life expectancy of 10 years or more 7. Written informed consent 8. Patients must be prepared to attend follow-up 9. For template biopsy sub-study must be considered fit for general / spinal anaesthetic; Target Gender: Male ; Lower Age Limit 18 no age limit or unit specified
  Who cannot enter the trial	1. Prior radiotherapy to the prostate or pelvis 2. Bilateral hip replacement 3. Prior hormone therapy 4. Radical prostatectomy 5. Lymph Node Risk > 30% 6. National Collaborative Cancer Network+ (NCCN) Favourable Risk Group 7. Evidence of seminal vesicle invasion, nodal or metastatic disease 8. Any previous invasive cancer in the past 5 years, with the exception of non-melanoma skin cancer 9. Patients with medical contraindication to magnetic resonance imaging (MRI) scanning
  What will happen	100 patients to be recruited and have MRI scans to diagnose intra-prostatic tumour nodules. 50% of patients expected to have lesions and so 50 patients to be treated with a radiotherapy boost Radiotherapy boost: A dose escalated external beam radiotherapy boost to intraprostatic tumour nodules within the prostate gland; Follow Up Length: 60 month(s); Study Entry : Registration only
  Primary aim	Late rectal toxicity; Timepoint(s): 12 months
  Secondary Aim	1. Acute genitourinary (Gu) and gastrointestinal (GI) toxicity; Timepoint(s): 18 weeks 2. Biochemical Recurrence; Timepoint(s): 24 months 3. Late GU and GI toxicity; Timepoint(s): 12 months and 24 months 4. Quality of Life Scores; Timepoint(s): 24 months
  Participant Information Sheet	Not available in web format, please use the contact details below to request a patient information sheet
  Website	Sorry, not currently available
  Recruitment Status	Recruiting
  Nation	England
  Location	Sutton

• Contact

  -

  Contact for Public Queries	Ms Annie Gao Downs Road Sutton SM2 5PT United Kingdom annie.gao@rmh.nhs.uk
  Contact for Scientific Queries	Sorry, not currently available