TAPS01
Research type
Research Study
Full title
Targeted drug intervention to inhibit cancer progression in men on active surveillance for prostate cancer. Therapeutics in Active Prostate cancer Surveillance (TAPS01)
IRAS ID
228629
Contact name
Vincent Gnanapragasam
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust & The University of Cambridge
Eudract number
2017-001700-29
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 2 months, 1 days
Research summary
The number of men diagnosed with prostate cancer is ever increasing. In the UK 46,690 men were diagnosed in 2014 alone and it is estimated this figure will be closer to 70,000 by 2030. A significant proportion will present with low or intermediate risk disease. Current therapeutic interventions (e.g. radical therapies such as surgery)for localised prostate cancer have significant morbidities. A number of studies have shown that Active Surveillance (AS) is safe and although it is commonly advocated for men with low risk disease, it can be controversial for men with intermediate risk disease. However, increasingly there is interest in using AS for this cohort of patients.
While attracted by the non-interventional approach of AS, many men are also concerned about their disease progressing if nothing is used to intervene. Current methods of intervention for men on AS (e.g. cryoablation) are expensive and can cause functional damage as such, the idea of systemic drug delivery has become more appealing. Androgen Deprivation Therapy (ADT) is a mainstay of management however, long-term use can result in damaging side effects. There is sufficient evidence that pharmacological intervention used as short-term therapy in men with low to intermediate risk disease can prevent the growth of prostate tumours and delay the need for radical therapy in men managed by AS.
This window study will be built on the known anti-androgen effects of apalutamide and investigate the efficacy of using it as a short-term intervening strategy to reduce tumour volume. Tumour volume will be measured using the well established method of multi-parametric MRI (mpMRI).
The study will be conducted in one NHS centre in the UK where 10 evaluable participants aged 18 and over will be recruited. Any participants that are withdrawn and considered not evaluable will be replaced.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
18/EE/0047
Date of REC Opinion
5 Apr 2018
REC opinion
Further Information Favourable Opinion