BIOPROP20: Biologically Optimised IMRT for Prostate Radiotherapy Hypofractionated Radiotherapy With Intra-prostatic Boosts to Tumour Nodules in Men With Intermediate and High Risk Prostate Cancer (BIOPROP20)

October 27, 2019 updated by: The Clatterbridge Cancer Centre NHS Foundation Trust
High dose radiotherapy is a very effective treatment for prostate cancer. However, there is an increased risk of side effects compared to lower dose radiotherapy. This study will investigate the use of dose painting radiotherapy. Dose painting radiotherapy administers a high dose of radiotherapy to areas of cancer inside the prostate and a lower (standard) dose to the rest of the prostate. This may improve control of the cancer without increasing the side effects. The radiotherapy is given in 20 doses, called fractions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

For patients with prostate cancer which has not spread, the typical treatment is hormone therapy and radiotherapy.

It is possible to identify areas within the prostate which contain a significant amount of cancer with functional MRI or with 18F choline PET CT scans. These areas are called Dominant Intraprostastic Lesions 'DILs'. Targeted prostate biopsies help to confirm scan results. The radiotherapy dose to the DILs is increased, whilst the rest of the prostate is treated with the standard dose. This technique is called dose painting or 'boost' Intensity Modulated Radiotherapy Treatment (IMRT).

IMRT is given in 37 treatment doses called fractions, once a day for about 8 weeks. A hypofractionated schedule is the administration of the total radiotherapy treatment over a smaller number of fractions, at a higher dose per fraction. Recent evidence suggests that the idea of using a 'hypofractionated' treatment schedule is better and more convenient with a similar number of side effects as a regular schedule.

In the study, 50 patients with intermediate/high risk prostate cancer suitable and fit for radical radiotherapy will be recruited. The patients undergo a staging functional MRI scan, fiducial marker insertion (required for image guided radiotherapy) and hormone therapy as per standard of care treatment. The choline PET CT scan and targeted prostate biopsies are optional. They are useful if the MRI is difficult to interpret and will be offered to patients if they are felt to be appropriate by the clinician. After 2 months hormone therapy (standard protocol) patients have a CT /MRI planning scan and undergo IMRT with 20 treatments (fractions).The patient will then be followed up until 24 months after they started radiotherapy treatment.

The main aim is to assess the side effects related to the bladder and bowel at 18 weeks (acute toxicity) after starting hypofractionated IMRT.

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Wirral
      • Bebington, Wirral, United Kingdom, CH63 4JY
        • The Clatterbridge Cancer Centre NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Histologically confirmed adenocarcinoma of the prostate
  2. NCCN intermediate/high risk disease and estimated risk of lymph node involvement 15 - 40%*
  3. MRI stage T2a-T4 N0M0
  4. Age 18-80 years
  5. Normal blood count (Hb >11g/dl, WBC > 4000/mm3, platelets >100,000/mm3)
  6. WHO performance status 0 or 1

  7. Fully informed written consent

    • Risk of pelvic lymph node involvement = (Gleason score - 6) x 10 + 2/3 PSA

Exclusion Criteria:

  1. Prior radiotherapy to the prostate or pelvis
  2. Prior hormone therapy or radical prostatectomy
  3. Total hip replacement
  4. Clinically significant inflammatory bowel disease
  5. Contraindication to have diagnostic MRI scans
  6. Unable to have a general anaesthetic
  7. Anti-coagulant therapy which cannot be temporarily stopped

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hypofractionated IMRT boost Radiotherapy
Radiation: Hypofractionated IMRT boost Radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Acute bladder and bowel toxicity (NCI CTCAE v 4.0 and RTOG) at 18 weeks after the commencement of radiotherapy treatment
Time Frame: 18 weeks
18 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
The success rate of producing dose painted IMRT plans which fulfill the dose-volume constraints as specified for the prostate and for the normal tissues
Time Frame: 3 years
3 years
Late bladder and bowel toxicity (NCI CTCAE v4) at 2 years
Time Frame: 2 Years
2 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Clatterbridge Cancer Centre NHS Foundation Trust

Investigators

  • Principal Investigator: Isabel Syndikus, MD, The Clatterbridge Cancer Centre NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

September 1, 2018

Study Completion (Actual)

September 1, 2019

Study Registration Dates

First Submitted

April 17, 2014

First Submitted That Met QC Criteria

April 25, 2014

First Posted (Estimate)

April 29, 2014

Study Record Updates

Last Update Posted (Actual)

October 29, 2019

Last Update Submitted That Met QC Criteria

October 27, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RDD547

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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