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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Whole body MRI | Experimental | Comparing the detection rate of metastases of whole body MRI compared to current standard of care tests - Choline PET and Bone scan. |
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| MRI Targeted Biopsies | Experimental | Transperineal MRI-targeted biopsies and whole-gland transperineal prostate mapping biopsies |
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| Focal Salvage Therapy | Experimental | Focal salvage HIFU and cryotherapy of recurrent prostate cancer tumors only |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whole Body MRI | Device | Full parametric MRI using T1W, T2W, Diffusion-weighted and dynamic-contrast-enhanced images at 3Tesla |
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| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| To determine urinary incontinence rates after focal salvage therapy to localised recurrent prostate cancer? | Treatment Continence Presence of urinary incontinence (any pad usage) as determined by the UCLA-EPIC urinary continence questionnaire, at 12 months, in those men with no urinary incontinence at baseline | 2 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Abi A Kanthabalan, MBChB | Contact | +44(0)2034479194 | ana-k@doctors.org.uk | |
| Hashim U Ahmed, FRCS, PhD | Contact | +44(0)2034479194 | hashim.ahmed@ucl.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Hashim U Ahmed, FRCS, PhD | University College London Hospitals | Study Chair |
| Manit Arya, FRCS | University College London Hospitals | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hampshire Hospitals NHS Trust | Recruiting | London | NW1 2BU | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37778954 | Derived | Light A, Kanthabalan A, Otieno M, Pavlou M, Omar R, Adeleke S, Giganti F, Brew-Graves C, Williams NR, Emara A, Haroon A, Latifoltojar A, Sidhu H, Freeman A, Orczyk C, Nikapota A, Dudderidge T, Hindley RG, Virdi J, Arya M, Payne H, Mitra AV, Bomanji J, Winkler M, Horan G, Moore CM, Emberton M, Punwani S, Ahmed HU, Shah TT. The Role of Multiparametric MRI and MRI-targeted Biopsy in the Diagnosis of Radiorecurrent Prostate Cancer: An Analysis from the FORECAST Trial. Eur Urol. 2024 Jan;85(1):35-46. doi: 10.1016/j.eururo.2023.09.001. Epub 2023 Sep 29. | |
| 37385981 |
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Whole-body MRI and Focal salvage therapy
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| Focal Salvage Therapy | Procedure | Cryotherapy and HIFU will be used to targeted the areas of tumor only with a margin of normal tissue. |
|
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| MRI Targeted biopsies | Procedure | Image registration will be used to target biopsies followed by full mapping biopsies of the prostate. All biopsies will be carried out transperineally |
|
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| Mark Emberton, FRCS, MD |
| University College London Hospitals |
| Principal Investigator |
| Shonit Punwani, FRCR | University College London Hospitals | Principal Investigator |
| University College London Hospitals | Recruiting | London | NW1 2BU | United Kingdom |
|
| Derived |
| Light A, Peters M, Reddy D, Kanthabalan A, Otieno M, Pavlou M, Omar R, Adeleke S, Giganti F, Brew-Graves C, Williams NR, Emara A, Haroon A, Latifoltojar A, Sidhu H, Freeman A, Orczyk C, Nikapota A, Dudderidge T, Hindley RG, Virdi J, Arya M, Payne H, Mitra AV, Bomanji J, Winkler M, Horan G, Moore C, Emberton M, Punwani S, Ahmed HU, Shah TT. External validation of a risk model predicting failure of salvage focal ablation for prostate cancer. BJU Int. 2023 Nov;132(5):520-530. doi: 10.1111/bju.16102. Epub 2023 Jun 29. |
| 35370021 | Derived | Shah TT, Kanthabalan A, Otieno M, Pavlou M, Omar R, Adeleke S, Giganti F, Brew-Graves C, Williams NR, Grierson J, Miah H, Emara A, Haroon A, Latifoltojar A, Sidhu H, Clemente J, Freeman A, Orczyk C, Nikapota A, Dudderidge T, Hindley RG, Virdi J, Arya M, Payne H, Mitra A, Bomanji J, Winkler M, Horan G, Moore CM, Emberton M, Punwani S, Ahmed HU. Magnetic Resonance Imaging and Targeted Biopsies Compared to Transperineal Mapping Biopsies Before Focal Ablation in Localised and Metastatic Recurrent Prostate Cancer After Radiotherapy. Eur Urol. 2022 Jun;81(6):598-605. doi: 10.1016/j.eururo.2022.02.022. Epub 2022 Mar 31. |