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Adaptive Radiotherapy for High-risk Prostate Cancer Using Multiparametric MRI

Adaptive Radiotherapy for High-risk Prostate Cancer Using Multiparametric MRI (ARPC-MRI) - a Feasibility Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03967080
Acronym
ARPC-MRI
Enrollment
5
Registered
2019-05-30
Start date
2019-02-05
Completion date
2024-09-01
Last updated
2025-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Brief 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.

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.

Interventions

None listed

Sponsors

East and North Hertfordshire NHS Trust
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

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

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.

Design outcomes

Primary

MeasureTime frameDescription
Reproducability of DW-MRI7 monthsApparent diffusion coefficient (ADC)
Reproducibility of DCE-MRI7 monthsUsing volume transfer constant
MP-MRI Response Correlation7 monthsDeveloping 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
Assessment of adapted dosimetryAfter week 3 of radiotherapyAmount of acceptable radiotherapeutic dose

Secondary

MeasureTime frameDescription
Assessment of cell kill3 monthsProportion of cells killed at given dose following androgen deprivation therapy
Tumour response prediction7 monthsAssess which proportion of tumours demonstrate areas of poor response that could benefit from adaptive radiotherapy

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026