Adaptive Radiotherapy for High-risk Prostate Cancer Using Multiparametric MRI

Prostate Cancer Clinical Trial

— ARPC-MRI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03967080
• Other study ID #: RD2018-46
• Status: Recruiting
• Start date: February 5, 2019
• Est. completion date: September 30, 2022

Study information

• Verified date: December 2020
• Source: East and North Hertfordshire NHS Trust
• Contact: Roberto Alonzi
• Phone: 0203 826 2166
• Email: ralonzi[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: September 30, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
United Kingdom	East and North Hertfordshire NHS Trust	Northwood	Middlesex

Sponsors (1)

Lead Sponsor	Collaborator
East and North Hertfordshire NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reproducability of DW-MRI	Apparent diffusion coefficient (ADC)	7 months
Primary	Reproducibility of DCE-MRI	Using volume transfer constant	7 months
Primary	Reproducibility of DCE-MRI	Using leakage space as a percentage of unit volume	7 months
Primary	Reproducibility of DCE-MRI	Using rate constant	7 months
Primary	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	7 months
Primary	Assessment of adapted dosimetry	Amount of acceptable radiotherapeutic dose	After week 3 of radiotherapy
Secondary	Assessment of cell kill	Proportion of cells killed at given dose following androgen deprivation therapy	3 months
Secondary	Tumour response prediction	Assess which proportion of tumours demonstrate areas of poor response that could benefit from adaptive radiotherapy	7 months