RADICALS-TR: A translational study
Research type
Research Study
Full title
RADICALS-TR: A translational study of samples from the Radiotherapy and Androgen Deprivation In Combination After Local Surgery (RADICALS) prostate cancer trial to identify those most likely to benefit from androgen deprivation with salvage radiotherapy
IRAS ID
329626
Contact name
Matthew W Fittall
Contact email
Sponsor organisation
University College London
Duration of Study in the UK
4 years, 8 months, 1 days
Research summary
Early prostate cancer represents a wide spectrum of disease. Indolent disease is unlikely to ever become symptomatic and treatment is needlessly morbid and costly. Aggressive disease warrants intensification of therapy. Current clinical methods are poor at discriminating these outcomes.
The RADICALS trial was the largest trial conducted to date in men requiring further curative treatment after an operation. It already defined the role for radiotherapy after surgery (prostatectomy). The standard of care is now for blood test (PSA) monitoring after prostatectomy with radiotherapy offered when the PSA rises. The role and duration of hormone treatment (androgen deprivation), given in combination with radiotherapy, remains less clear. Currently if androgen deprivation is to be given, the RADICALS data support the use of a 24-month course, but this entails a considerable burden of side-effects for patients. Pathological and biological markers are needed to identify those most likely to benefit from androgen deprivation.
In RADICALS-TR, we will conduct translational analyses on the biopsy and prostatectomy specimens from the RADICALS trial. We aim to identify prognostic features and biomarkers predictive of benefit from androgen therapy. We will prioritise the refinement and validation of clinical biomarkers already close to clinical utilisation. In this way it is hoped that findings can rapidly translate to stratified clinical trials and improved patient care.REC name
East of England - Cambridge South Research Ethics Committee
REC reference
23/EE/0249
Date of REC Opinion
30 Nov 2023
REC opinion
Further Information Favourable Opinion