免费获得国外相关药品,最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Adaptive Radiotherapy for High-risk Prostate Cancer Using Multiparametric MRI (ARPC-MRI)

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

Study Description
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.

Condition or disease
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.

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Adaptive Radiotherapy for High-risk Prostate Cancer Using Multiparametric MRI (ARPC-MRI) - a Feasibility Study
Actual Study Start Date : February 5, 2019
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : September 30, 2022
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. Reproducability of DW-MRI [ Time Frame: 7 months ]
    Apparent diffusion coefficient (ADC)

  2. Reproducibility of DCE-MRI [ Time Frame: 7 months ]
    Using volume transfer constant

  3. Reproducibility of DCE-MRI [ Time Frame: 7 months ]
    Using leakage space as a percentage of unit volume

  4. Reproducibility of DCE-MRI [ Time Frame: 7 months ]
    Using rate constant

  5. MP-MRI Response Correlation [ Time Frame: 7 months ]
    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

  6. Assessment of adapted dosimetry [ Time Frame: After week 3 of radiotherapy ]
    Amount of acceptable radiotherapeutic dose


Secondary Outcome Measures :
  1. Assessment of cell kill [ Time Frame: 3 months ]
    Proportion of cells killed at given dose following androgen deprivation therapy

  2. Tumour response prediction [ Time Frame: 7 months ]
    Assess which proportion of tumours demonstrate areas of poor response that could benefit from adaptive radiotherapy


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Study looks at High-risk prostate cancer, female participants are excluded.
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.
Criteria

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.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Roberto Alonzi 0203 826 2166 ralonzi@nhs.net
Contact: Angela Turnbull 0203 826 2313 angelaturnbull@nhs.net

Locations
Layout table for location information
United Kingdom
East and North Hertfordshire NHS Trust Recruiting
Northwood, Middlesex, United Kingdom, HA6 2RN
Contact: Roberto Alonzi    0203 826 2166    ralonzi@nhs.net   
Contact: Angela Turnbull    02038262313    angelaturnbull@nhs.net   
Sponsors and Collaborators
East and North Hertfordshire NHS Trust
Tracking Information
First Submitted Date May 22, 2019
First Posted Date May 30, 2019
Last Update Posted Date December 16, 2020
Actual Study Start Date February 5, 2019
Estimated Primary Completion Date March 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 19, 2019)
  • Reproducability of DW-MRI [ Time Frame: 7 months ]
    Apparent diffusion coefficient (ADC)
  • Reproducibility of DCE-MRI [ Time Frame: 7 months ]
    Using volume transfer constant
  • Reproducibility of DCE-MRI [ Time Frame: 7 months ]
    Using leakage space as a percentage of unit volume
  • Reproducibility of DCE-MRI [ Time Frame: 7 months ]
    Using rate constant
  • MP-MRI Response Correlation [ Time Frame: 7 months ]
    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
  • Assessment of adapted dosimetry [ Time Frame: After week 3 of radiotherapy ]
    Amount of acceptable radiotherapeutic dose
Original Primary Outcome Measures
 (submitted: May 28, 2019)
  • Reproducability of MRI [ Time Frame: 4.5 months ]
    Including the apparent diffusion coefficient (ADC) for DCE MRI
  • MP-MRI Measurability [ Time Frame: at 3 weeks of RT ]
    MP-MRI sequence measurement within the dominant tumour nodule
  • MP-MRI Response Correlation [ Time Frame: 7 months ]
    Developing methods to identify and delineate areas of tumour according to their response to radiotherapy treatment by correlating parameters such as ADC, Ktrans, ve and kep with the anatomical T2 MRI images
  • Evaluating dosimetry [ Time Frame: 7 months ]
    Amount of acceptable radiotherapeautic dose
Change History
Current Secondary Outcome Measures
 (submitted: May 28, 2019)
  • Assessment of cell kill [ Time Frame: 3 months ]
    Proportion of cells killed at given dose following androgen deprivation therapy
  • Tumour response prediction [ Time Frame: 7 months ]
    Assess which proportion of tumours demonstrate areas of poor response that could benefit from adaptive radiotherapy
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Adaptive Radiotherapy for High-risk Prostate Cancer Using Multiparametric MRI
Official Title Adaptive Radiotherapy for High-risk Prostate Cancer Using Multiparametric MRI (ARPC-MRI) - a Feasibility Study
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Prostate Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 28, 2019)
15
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 30, 2022
Estimated Primary Completion Date March 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Gender Eligibility Description: Study looks at High-risk prostate cancer, female participants are excluded.
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Roberto Alonzi 0203 826 2166 ralonzi@nhs.net
Contact: Angela Turnbull 0203 826 2313 angelaturnbull@nhs.net
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT03967080
Other Study ID Numbers RD2018-46
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party East and North Hertfordshire NHS Trust
Study Sponsor East and North Hertfordshire NHS Trust
Collaborators Not Provided
Investigators Not Provided
PRS Account East and North Hertfordshire NHS Trust
Verification Date December 2020

治疗医院