Adaptive Radiotherapy for High-risk Prostate Cancer Using Multiparametric MRI

NCT03967080 | Completed

• 1 other identifier: RD2018-46
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (6)

• Reproducability of DW-MRI

  Apparent diffusion coefficient (ADC)

  7 months

• Reproducibility of DCE-MRI

  Using volume transfer constant

  7 months

• Reproducibility of DCE-MRI

  Using leakage space as a percentage of unit volume

  7 months

• Reproducibility of DCE-MRI

  Using rate constant

  7 months

• 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

• Assessment of adapted dosimetry

  Amount of acceptable radiotherapeutic dose

  After week 3 of radiotherapy

Secondary Outcomes (2)

• Assessment of cell kill

  3 months

• Tumour response prediction

  7 months

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Study looks at High-risk prostate cancer, female participants are excluded.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• East and North Hertfordshire NHS Trust: lead

Study Sites (1)

East and North Hertfordshire NHS Trust

Northwood, Middlesex, HA6 2RN, United Kingdom

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2019
• First Posted: May 30, 2019
• Study Start: February 5, 2019
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: September 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)