Condition category
Cancer
Date applied
17/08/2011
Date assigned
17/08/2011
Last edited
01/12/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Ms Annie Gao

ORCID ID

Contact details

Downs Road
Sutton
SM2 5PT
United Kingdom
-
annie.gao@rmh.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

10309

Study information

Scientific 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

Study hypothesis

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.

Ethics approval

11/LO/0510

Study design

Non-randomised; Interventional; Design type: Process of Care, Treatment

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

Topic: National Cancer Research Network; Subtopic: Prostate Cancer; Disease: Prostate

Intervention

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

Intervention type

Other

Phase

Phase II

Drug names

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

Overall trial start date

13/07/2011

Overall trial end date

20/07/2014

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Male

Target number of participants

Planned Sample Size: 100; UK Sample Size: 100

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

Recruitment start date

13/07/2011

Recruitment end date

20/07/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Downs Road
Sutton
SM2 5PT
United Kingdom

Sponsor information

Organisation

Institute for Cancer Research (UK)

Sponsor details

Section of Clinical Trials
15 Cotswold Road
Sutton
SM2 5NG
United Kingdom

Sponsor type

Research organisation

Website

Funders

Funder type

Charity

Funder name

Cancer Research UK (CRUK) (UK)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

01/12/2016: No publications found in PubMed, verifying study status with principal investigator.