FOcal RECurrent Assessment and Salvage Treatment

Study Overview
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Brief Summary
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Radiotherapy is the commonest form of prostate cancer treatment in the UK. In one in four men, radiotherapy will fail to control the cancer. These men are offered hormonal treatment which has significant side effects. Few men are offered a further treatment such as surgery, HIFU or cryotherapy. Only half of these men are cancer free at 5 years. The investigators believe this is due to poor imaging tests such as CT and Bone scan that cannot accurately detect whether cancer has come back inside or outside of the prostate or both. Also radiotherapy damages tissue surrounding the prostate which affects tissue healing for example after surgery. Treating just the cancer in the prostate only (focal treatment) rather than the whole prostate may limit this damage and cause fewer side-effects. The investigators want to see if new imaging tests can better identify cancer that has spread outside of the prostate and areas of cancer inside the prostate. Our new tests are whole-body MRI (for distant disease) and MRI guided biopsies (MRI-TB) (for local disease). First, the investigators will compare the results of whole-body MRI to existing imaging tests (bone-scan, and choline PET/CT) that try to find distant spread. Second, the investigators will compare the results of MRI-TB to a very detailed and accurate biopsy of the prostate called template prostate mapping which will show us where and how aggressive the cancer is. Third, if the cancer is confined to the prostate, the investigators will treat men using focal salvage therapies HIFU and cryotherapy. The investigators believe that these new imaging tests could better identify those who will benefit from early hormone treatment and those who will benefit from local salvage treatment. Our study may help justify carrying out a larger trial looking at how good the treatment is in controlling cancer in the medium and long-term.

Official Title
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An Evaluation of a Novel Imaging Based Complex Diagnostic and Therapeutic Pathway Intervention for Men Who Fail Radiotherapy for Prostate Cancer.

Conditions
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Progression of Prostate Cancer

Intervention / Treatment
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* Device: Whole Body MRI
* Procedure: Focal Salvage Therapy
* Procedure: MRI Targeted biopsies


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Previous external beam radiotherapy with or without neo-adjuvant/adjuvant hormone therapy Biochemical failure as defined by the Phoenix criteria (PSA nadir + 2ng/ml) Men considering local salvage treatment for radio-recurrent disease Life expectancy of 5 years or more Exclusion Criteria: Have taken any form of hormones (except 5-alpha reductase inhibitors) within the previous 6 months Unable to have MRI scan as defined by standard care practice Metallic implant likely to cause artefact and reduce scan quality PSA doubling time of 3 months or less PSA value 20ng/ml or greater Prior prostate biopsies following biochemical failure Any prior local intervention to the prostate (e.g., laser/electrical resection or incision, cryotherapy, HIFU, any other ablative modality, any other radiotherapy, any other prostate injection therapy for symptoms or cancer control) Unable to have general or regional anaesthesia Unable to give informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Whole-body MRI and Focal salvage therapy
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Whole body MRI<br>Comparing the detection rate of metastases of whole body MRI compared to current standard of care tests - Choline PET and Bone scan. | Device: Whole Body MRI<br>* Full parametric MRI using T1W, T2W, Diffusion-weighted and dynamic-contrast-enhanced images at 3Tesla<br>* Other names: CE0344;|
| Experimental: MRI Targeted Biopsies<br>Transperineal MRI-targeted biopsies and whole-gland transperineal prostate mapping biopsies | Procedure: MRI Targeted biopsies<br>* Image registration will be used to target biopsies followed by full mapping biopsies of the prostate. All biopsies will be carried out transperineally<br>* Other names: SmartTarget software for image-registration;|
| Experimental: Focal Salvage Therapy<br>Focal salvage HIFU and cryotherapy of recurrent prostate cancer tumors only | Procedure: Focal Salvage Therapy<br>* Cryotherapy and HIFU will be used to targeted the areas of tumor only with a margin of normal tissue.<br>* Other names: Cryotherapy Serial Number: Cat No FPRCH 2024;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of whole body MRI in identifying distant disease | Whole body MRI lesions suspicious of lymph node, visceral or bone metastases compared to standard care tests - Sensitivity, specificity, negative and positive predictive values of whole-body MRI to detect distant disease compared to standard care tests (isotope bone-scan, PET/CT-scan, with skeletal survey where appropriate) and/or pelvic lymphadenectomy and/or biopsy of distant areas in indeterminate cases | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Can multiparametric MRI accurately detect localised recurrent prostate cancer | Imaging of Local Disease Transperineal multi-parametric MRI targeted biopsies compared to Template Prostate Mapping biopsies in the detection of UCL definition 2 clinically significant prostate cancer (Gleason >/=3+4 AND/OR Maximum Cancer Core Length >/=4mm in any one biopsy) | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIFU, Biochemical Failure, Radiotherapy, Radiorecurrent Prostate Cancer, MRI Prostate, Whole Body MRI, Bone Scan, Choline PET, Focal Salvage Treatment, Cryotherapy