Exciting New Prostate Cancer Study

TALAPRO-3: A Phase 3, Randomized, double-blind, study of Talazoparib with Enzalutamide Versus Placebo with Enzalutamide in Men with DDR Gene mutated Metastatic Castration-Sensitive Prostate Cancer

We are now open to this PARP Inhibitor study for patients with newly diagnosed metastatic prostate cancer.

Patients with BRCA mutations have more aggressive disease, and this study is looking at the value of adding PARP Inhibitor to standard treatment if the patients have the mutation.

We aim to pre-screen 25 patients for the mutation by sending off a blood sample and a tumour sample to Foundation Medicine Lab in USA for analysis.

We predict 3 patients will then go on the be randomised into the treatment part of the study.

The trial was given the Green light on 15/7/22 and the first patient has been identified.

Renal Study Success

The EMPA-KIDNEY Study: A multicentre international randomized parallel group double-blind placebo-controlled clinical trial of EMPAgliflozin once daily to assess cardio-renal outcomes in patients with chronic KIDNEY disease

Empa-Kidney is a three-year study looking at the effects of empagliflozin on people with renal disease.

We had 25 patients here in Exeter, who came in for 6 monthly visits.

Earlier this year we had the exciting news that the study is stopping early as they have proved efficacy.

This will have a significant effect on the treatment of renal disease as empagliflozin will slow the rate of decline and therefore lengthen the time before transplant or dialysis is needed.

This is a significant milestone in improving the quality of life in people with kidney disease as treatments currently focus on symptom management and good blood pressure control.

Empagliflozin is already licenced for diabetes and cardiovascular disease, so hopefully it will be licensed soon for renal patients.

Cystic Fibrosis Trust: Annual Review

A summary of what Sophie Whitely and her team have been working on for the Cystic Fibrosis Trust

Extract from annual report for RD&E:

Highlights & Strengths:

• Among the top 3 CTAP sites for fastest average time from site selection to first patient recruited (when looking at all data since CTAP launch)

• Among the top 3 CTAP sites for fastest average time to contract approval (when looking at all data since CTAP launch)

• 100% retention rate this year

• 75% increase in overall (Adult + Paediatric) recruitment this year

• Site with the highest recruitment to the NIHR CF BioResource this year

Completion of study and patient feedback

National Lung Matrix Trial: Multi-­drug, genetic marker-directed, non­-comparative, multi-­centre, multi­-arm phase II trial in non-small cell lung cancer.

Dawn and Lizzie looked after a patient in the Lung Matrix trial over a 12-month period. He sadly died last month but his wife was so grateful to them for all the care and kindness they had shown them both.

Over £500 was raised at the funeral with a wish for it to be donated to clinical trials, and will be given to the RDE charity.

Recruitment Highlights

TIPAL: The effectiveness and risks of Treating people with Idiopathic Pulmonary fibrosis with the Addition of Lansoprazole (TIPAL): a randomised placebo-controlled multi-centre clinical trial

We are leading recruiters for TIPAL at the moment!!!! 6 patients randomised, the target was 5.

GenOMICC: Genetics of susceptibility and mortality in critical care.

Royal Devon And Exeter Hospital was in the top 10 recruiting sites across the UK over the last 14 days

UK-ROX: Evaluating the clinical and cost-effectiveness of a conservative approach to oxygen therapy for invasively ventilated adults in intensive care.

155 patients out of a target of 166 – 10 to go!