Focal Therapy Training
Consultant Urologists alone should be permitted to deliver the therapy as the specialist knowledge and pre and post-operative care required necessitates skills which only reside within this specialty.
Clinicians will undergo training and proctoring to ensure treatment is delivered to a standard laid down by a reference centre (currently Imperial, UCLH, Southampton and Basingstoke for HIFU and Imperial, Southampton and Sunderland for cryotherapy.
Urologists must read the training manual provided by the manufacturer and/or distributor of the device and must complete any and all compulsory online training modules provided by the manufacturer and/or distributor of the device
Urologists without previous HIFU or cryotherapy experience or who have not carried out any HIFU or cryotherapy procedures for a minimum period of one year will be required to visit a training centre and observe at least 2 cases of focal HIFU or cryotherapy (on one or two visits).
Urologists with previous HIFU or cryotherapy experience who have not carried out any HIFU or cryotherapy cases for a minimum period of one year or who are below the requisite minimum number of cases per year (currently 12) will be required to undergo proctoring.
Proctoring needs to be carried out at on at least the first 5 cases for those urologists who have never carried out HIFU or cryotherapy before. This number can be less than 5 proctored cases for those urologists who have carried out HIFU or cryotherapy previously. The minimum number may be extended at the discretion of the proctor particularly if the period between proctored cases is prolonged (currently 3 months). The advice is to err on the side of caution if there is doubt and extend the proctoring period.
The proctored cases and the first 10 cases without proctoring should undergo case review of treatment delivery and early 1-2 week gadolinium contrast enhanced MRI centrally by an expert proctor. This review will be conducted in an iterative manner so treatments subsequent to this can also be reviewed if necessary for ongoing optimisation of treatment delivery.
At the end of such second or third session, the Proctor will decide whether to sign off the Consultant. For the next three theatre sessions, an Application Specialist shall attend to help the Consultant.
Each urologist is currently required to perform at least 12 focal therapy cases within a year to maintain independent status.
The designation of a proctor is performed by following at least one year of independent status conforming to minimum numbers and is authorized by the manufacturer/distributor on the advice of one expert proctor who will review a selection of cases from the urologist.
A 1-2 week mpMRI is required for the first 5 HIFU or cryotherapy patients in sites new to performing HIFU or cryotherapy.
Upon the Proctor or Trainer signing off the new Consultant as independent, such Proctor should do this in writing as a letter or email.