| Condition or disease |
|---|
| Prostate Cancer |
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 |
| 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 |
| 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 |
Inclusion Criteria:
New diagnosis of high-risk prostate cancer: any of:
Exclusion Criteria:
| Contact: Roberto Alonzi | 0203 826 2166 | ralonzi@nhs.net | |
| Contact: Angela Turnbull | 0203 826 2313 | angelaturnbull@nhs.net |
| 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 | |
| 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 |
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| Original Primary Outcome Measures |
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| Change History | |||||||||
| Current Secondary Outcome Measures |
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| 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. |
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| Study Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| 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. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
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:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| 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 |
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| IPD Sharing Statement |
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| 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 | ||||||||