A research team at Northern Lincolnshire and Goole NHS Foundation Trust has recruited the first patient in the UK to the HERO study, which is looking at treatment for men with advanced prostate cancer.
The study is assessing the effectiveness and safety of an oral investigational medicine, relugolix, which suppresses testosterone levels. Prostate cancer cells often require androgen hormones (male hormones) such as testosterone, to grow. The study is designed to evaluate whether reducing testosterone can provide potential treatment for patients with advanced prostate cancer.
The HERO study participants are randomised to either the investigational medicine, relugolix, which is taken in tablet form once a day or current standard of care, leuprolide acetate, which is an injection carried out every three months.
Kathy Dent, Lead Research Nurse at the trust, who recruited the first patient, said: “Our recruitment success is due to the hard work of our long-established team.”
Dr Sanjay Dixit, Consultant Oncologist and Principal Investigator at the trust, said: “The study will give us an invaluable insight into the impact of existing treatments and newer ones, on outcomes and patients’ quality of life.”
Study participants are followed-up monthly, with more frequent visits at the start of treatment. The patients receive treatment for at least a year.
Study participants will also experience a new medication reminder concept. A Clever Cap lid is placed on the tablet bottles which prompts the patient to take their medication to schedule, with the correct dose. It also notifies the research team if a dose has been missed or delayed, allowing the team to remind the patient to take their medication.
Kathy said: “Patients get a real sense of achievement when they contribute to studies as they know they are making a positive difference for patients in the future. They are playing a key part in advancing care and treatments.”
Internationally, approximately 900 patients are expected to be recruited to the study, which is planned to complete in 2020. Northern Lincolnshire and Goole NHS Foundation Trust has an initial target of five recruits.
HERO is a Phase 3 study open to men 18 and over with androgen-sensitive advanced prostate cancer, who need at least one year of continuous androgen deprivation therapy (ADT) – suppressing the levels of male hormones in the body. The patients must not be eligible for surgical therapy.
If you are interested in taking part in a clinical trial you can search the UK Clinical Trials Gateway https://www.ukctg.nihr.ac.uk/ for one that may be suitable for you.
*This article (published 23 May 2018) is from the NIHR website and is approved by Myovant Sciences, Inc.