RENAISSANCE
Research type
Research Study
Full title
RENAISSANCE - A multi-centre, non-interventional study of RElugolix as aNdrogen-deprivAtion therapy In patientS with advanced hormone-Sensitive prostate cANCEr
IRAS ID
344820
Contact name
Alison Birtle
Contact email
Sponsor organisation
Accord Healthcare Ltd
Clinicaltrials.gov Identifier
EUPAS1000000077, EU PAS number
Duration of Study in the UK
1 years, 11 months, 30 days
Research summary
This European, multicentric, prospective cohort study (i.e. non interventional) will be conducted in patients with advanced hormone sensitive prostate cancer who are initiating treatment with relugolix with a planned duration of treatment of at least twelve months.
Patients will undergo clinical assessments and receive standard medical care as determined by the patient’s investigator in a real-world practice.
All visits will be scheduled and conducted according to the clinical site’s routine clinical practice. Data will be extracted from the medical records and entered into the electronic data capture (EDC) following clinic visits.
Sites will be encouraged to extract data 3 times. To capture data on healthcare encounters that occur outside of the setting of the investigator, secondary data will be obtained electronically and imported into the study database on an as needed basis. Physicians are free to add or withdraw any medication. Relugolix or any other treatment will not be provided or paid for by Accord Healthcare. Evaluations and testing are as per routine care will not be provided or paid for by Accord Healthcare. Patients will not receive any experimental intervention or treatment as part of their participation in this study.
No mandatory visits, tests, or clinical assessments are required for this study. Patients will be followed prospectively for up to one year from the date of signed informed consent (enrolment) in order to ascertain patient outcomes for this time period. Follow-up will end with withdrawal of consent, loss to follow-up, death, or end of study data collection, whichever comes first.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
24/EM/0214
Date of REC Opinion
23 Sep 2024
REC opinion
Favourable Opinion