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CompletedNCT03967080ARPC-MRIUpdated Sep 3, 2025

Adaptive Radiotherapy for High-risk Prostate Cancer Using Multiparametric MRI

An observational study in Prostate Cancer, sponsored by East and North Hertfordshire NHS Trust. Completed at 1 site in United Kingdom. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-03.

Sponsored by East and North Hertfordshire NHS Trust · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
5
Ages
18 Years and older
Sex
Male
01

Study summary

This small study will investigate the feasibility of using multi-parametric MRI to introduce and support adaptive radiotherapy treatments for high-risk prostate cancer.

Read the detailed description

Mount Vernon Cancer Centre at East and North Hertfordshire NHS Trust offers patients with certain cancers a treatment called adaptive radiotherapy. The aim of adaptive radiotherapy is to respond to physical changes that occur during treatment to ensure the radiation continues to be directed at the cancer and to minimise the amount of healthy tissue treated. For example, if tumour shrinkage or weight loss occurs during head and neck radiotherapy the patient may have a repeat CT scan and a new radiotherapy treatment plan after a few weeks of treatment. For patients with cancer of the bladder or cervix changes in bladder and uterus size and position can be predicted allowing the prospective creation of three radiotherapy treatment plans, each day the best fitting plan, i.e. the one that closely covers the tumour whilst giving minimal dose to normal tissues, is selected and used for treatment, this is known as plan-of-the-day adaptive radiotherapy.

Small changes in shape and position of the prostate occur but are generally the result of rectal changes which cannot be predicted, consequently adaptive radiotherapy based on physical change is not possible for prostate cancer treatments. However, recent literature suggests that magnetic resonance imaging (MRI) can detect changes within the prostate in response to radiotherapy, some studies have seen changes as early as the second week of radiotherapy treatment. A feasibility study to investigate if these changes can support radiotherapy treatment plan adaption for prostate cancer treatments is proposed, whether the plan can be adapted to give a higher treatment dose to any areas of the prostate that show poor response to radiotherapy without increasing bowel and bladder dose is of particular interest. The treatment for patients who participate in the study would not be changed but the results may help to personalise and improve the treatment of future patients.

02

Conditions studied

  • Prostate Cancer

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03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 5 is below the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

East and North Hertfordshire NHS Trust is the lead sponsor of 36 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

15 male patients scheduled to receive androgen deprivation therapy and external beam radiotherapy for high-risk prostate cancer at Mount Vernon Cancer Centre.

Inclusion criteria

  1. New diagnosis of high-risk prostate cancer: any of:

    1. Gleason score of 8, 9 or 10
    2. PSA > 20
    3. T3/4
  2. Patient due to receive androgen deprivation therapy (ADT)
  3. Prescribed 78Gy/39# external beam radiotherapy
  4. Measurable dominant intraprostatic tumour on diagnostic imaging of at least 10mm diameter
  5. ≥18 years of age
  6. ECOG performance status of 0-1
  7. Informed, written and witnessed consent to participate is required.

Exclusion criteria

Exclusion Criteria:

  1. Patients who are not due to receive androgen deprivation therapy (ADT)
  2. Any contraindication to MRI scanning including contraindication to MRI contrast agents
  3. Previous radiotherapy to the pelvis
  4. Any physical or social reasons that would make attendance for additional visits impossible.
  5. Any patient with or planned for prostate fiducial markers.
  6. Unable to give informed consent.
  7. Patients currently enrolled in an interventional clinical trial.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
5 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Reproducability of DW-MRI

    Apparent diffusion coefficient (ADC)

    Time frame: 7 months

  2. Reproducibility of DCE-MRI

    Using volume transfer constant

    Time frame: 7 months

  3. Reproducibility of DCE-MRI

    Using leakage space as a percentage of unit volume

    Time frame: 7 months

  4. Reproducibility of DCE-MRI

    Using rate constant

    Time frame: 7 months

  5. MP-MRI Response Correlation

    Developing methods to identify and delineate areas of tumour according to their response to radiotherapy treatment by correlating MP-MRI kinetic parameters with anatomical T2 MRI images

    Time frame: 7 months

  6. Assessment of adapted dosimetry

    Amount of acceptable radiotherapeutic dose

    Time frame: After week 3 of radiotherapy

Secondary outcomes

  1. Assessment of cell kill

    Proportion of cells killed at given dose following androgen deprivation therapy

    Time frame: 3 months

  2. Tumour response prediction

    Assess which proportion of tumours demonstrate areas of poor response that could benefit from adaptive radiotherapy

    Time frame: 7 months

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Study locations

1 site
  • East and North Hertfordshire NHS Trust
    Northwood, Middlesex HA6 2RN, United Kingdom
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03967080
Lead sponsor
East and North Hertfordshire NHS Trust
Responsible party
Sponsor
First posted
May 30, 2019
Start date
Feb 5, 2019
Primary completion
Sep 1, 2024
Completion
Sep 1, 2024
Last update
Sep 3, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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