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 | Not Recruiting
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
DELINEATE
Trial Source

Health Conditions
  • Topic: National Cancer Research Network
  • Subtopic: Prostate Cancer
  • Disease: Prostate
Not Recruiting
Recruitment Status
ISRCTN04483921
Primary Trial ID Number
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.
Primary Outcome Measures
  • Late rectal toxicity; Timepoint(s): 12 months
Secondary Outcome Measures
  • 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
Research Question
  • 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 magnetic resonance (MR) imaging to identify tumour. The aim is to maintain current levels of late toxicity.
Design Type
Sorry, this information is not available
Ethics Approval
11/LO/0510
Publications
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Countries of Recruitment
United Kingdom
Participant Sex
Male
Participant Age Range
Adult
Participant Type
Patient
Trial Sample Size
100
Participant Inclusion Criteria
  • 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
Participant Exclusion Criteria
  • 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
Interventions
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
Design Details
Sorry, this information is not available
Study Design
Non-randomised; Interventional; Design type: Process of Care, Treatment
Results Reporting
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Acronym
DELINEATE
Scientific Title
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Secondary Trial Identifying Number
10309
Website
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Study Funded By
Cancer Research UK (CRUK) (UK)
Funder Type
Sorry, this information is not available
Study Sponsored By
Institute for Cancer Research (UK)
Study Also Sponsored By
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Primary Sponsor Type
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Secondary Sponsor Type
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Key Dates

Date of First Enrollment

13 Jul 2011

Recruitment End Date

20 Jul 2014

Trial End Date

20 Jul 2014

Date added to Registry

17 Aug 2011

Last Updated

18 Apr 2012