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Brief Title: FOcal RECurrent Assessment and Salvage Treatment
Official Title: An Evaluation of a Novel Imaging Based Complex Diagnostic and Therapeutic Pathway Intervention for Men Who Fail Radiotherapy for Prostate Cancer.
Study ID: NCT01883128
Brief Summary: 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Hampshire Hospitals NHS Trust, London, , United Kingdom
University College London Hospitals, London, , United Kingdom
Name: Hashim U Ahmed, FRCS, PhD
Affiliation: University College London Hospitals
Role: STUDY_CHAIR
Name: Manit Arya, FRCS
Affiliation: University College London Hospitals
Role: PRINCIPAL_INVESTIGATOR
Name: Mark Emberton, FRCS, MD
Affiliation: University College London Hospitals
Role: PRINCIPAL_INVESTIGATOR
Name: Shonit Punwani, FRCR
Affiliation: University College London Hospitals
Role: PRINCIPAL_INVESTIGATOR