Status:
UNKNOWN
FOcal RECurrent Assessment and Salvage Treatment
Lead Sponsor:
University College London Hospitals
Conditions:
Progression of Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
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 signific...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2019
Estimated Enrollment :
177 Patients enrolled
Trial Details
Trial ID
NCT01883128
Start Date
April 1 2014
End Date
October 1 2019
Last Update
May 10 2017
Active Locations (2)
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1
Hampshire Hospitals NHS Trust
London, United Kingdom, NW1 2BU
2
University College London Hospitals
London, United Kingdom, NW1 2BU