1. What clinical trials the Heart of England NHS Foundation Trust (HEFT) has operated/ offered to patients in relation to treatment of prostatitis/ prostate cancer;

The request did not specify a time point so the following is a list of trials which have been undertake at HEFT in the past 3 years:

Still recruiting:

–          Stampede: Systematic Therapy in Advancing or Metastatic prostate Cancer: Evaluation of Drug Efficacy. A 5-stage 6-arm randomised controlled trial (SPONSOR: Medical Research Council)

–          UK Genetics Prostate Cancer Study (SPONSOR: Institute of Cancer Research)

Patients in follow-up (Closed to recruitment)

–          Pivotal: A randomised phase II trial of prostate and pelvis versus prostate alone treatment for locally advanced prostate cancer (SPONSOR: Institute of Cancer Research)

–          RADICALS: Radiotherapy and Androgen Deprivation in Combination After Local Surgery. A randomised controlled trial for patients with prostate cancer (SPONSOR: Medical Research Council)

–          Conventional or Hypofractionated high Dose Intensity Modulated Radiotherapy for Prostate Cancer (CHHIP) (SPONSOR: Institute of Cancer Research)

Study completed (2015)

–          Randomised, Double-blind, Phase 3 Trial to Compare the Efficacy of Ipilimumab vs Placebo in Asymptomatic or Minimally Symptomatic patients with Metastatic Chemotherapy-Naive Castration Resistance Prostate Cancer (SPONSOR Bristol Myers Squab)

1. Whether HEFT has ever operated clinical trials on either High Intensity Focused Ultrasound (HIFU) or Green Light Laser;

No

1. If clinical trials were authorised by HEFT, what qualifications/ experience/training HEFT was required from their employees carrying out such treatment and what the governance structure was (alongside all documents setting out that the governance structure was in place and followed).

At minimum, the study would firstly need to be approved by the NHS’ National Research Ethics Service and the Health Research Authority (HRA). However this would depend on the study protocol requirements, for example if this was a drug trial it would also require the approval of the Medicines and Healthcare Products Regulatory Agency.

The HRA would perform the governance and legal compliance review of the study at a national level and would advise whether what is being proposed is permissible under the relevant UK regulations.  The forms which are submitted to the HRA include a section on radiology assessment and what is being performed, with a sign off by a Medical Physics Expert.  If it is passes this stage, locally, the Trust would then need to review the capacity and capability assessment on the study. This request would initially come in via the Research and Development department who then review the protocol to identify which of our support services are involved.  The information would then be passed on to the relevant staff.  HEFT has a dedicated research radiology team where any study which involves a radiological procedure is passed on to them for their review and approval. This team would review the protocol to answer the following questions:

1)      Do we offer the radiology procedures being requested?

2)      Do we have staff trained on this procedure to perform the study?

3)      Do they have capacity to perform the scans at the time points specified in the protocol?

4)      Is an ARSAC licence required?

5)      Is there a cost implication to undertaking this procedure – ie if this is additional scanning, which is not part of routine care, who is covering these costs?

Depending on what is highlighted in the above, it may result in the study being turned away due to either lack of capacity, capability or funding.