TAPS02
Research type
Research Study
Full title
Targeted drug intervention in men at risk of progression on active surveillance for early prostate cancer: A randomised trial – Therapeutics in Active Prostate cancer Surveillance (TAPS02).
IRAS ID
1005225
Contact name
Vincent Gnanapragasam
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust
Eudract number
2021-006106-75
Clinicaltrials.gov Identifier
Research summary
The number of men diagnosed with prostate cancer in the UK and worldwide is increasing. Many men are diagnosed with early cancers that may not need treatment and can be managed by a process called active surveillance (AS). In this process the cancer is closely monitored and if it reaches a certain stage (“progresses”) then radical therapy (such as surgery or radiotherapy) may be recommended. However, such treatment often causes long lasting side effects.
In the TAPS02 trial we are testing a drug called apalutamide which works by blocking androgens (male hormones) to slow down cancer growth. The trial will test if the short-term (3-6 months) use of apalutamide can slow cancer growth and make it less likely for men on AS to progress and need radical treatment. The use of apalutamide was previously tested in a small study (TAPS01), which showed that apalutamide had a good therapeutic effect for this patient population.
The TAPS02 study will include up to 402 patients on AS for prostate cancer and is planned to take place in up to 10 hospitals across the UK. The trial will occur in two stages: Pilot and Full Trial stage. In the Pilot stage, participants will be randomly selected to receive the drug apalutamide (for 3 or 6 months) or matched placebo (a dummy drug which looks exactly like apalutamide, but it contains no active drug). This stage will help us determine which treatment duration of apalutamide is better (3 or 6 months) which will then be used in the second stage. Participants will undergo routine and research tests and assessments including monthly blood tests during treatment, 4 magnetic resonance imaging (MRI) scans and a prostate biopsy. The trial duration is about 3.5 years and includes screening (up to 45 days), treatment period (6 months) and a 3 year follow-up.
If this trial is successful, it could mean a new way to manage early prostate cancer, and delay or avoid needing treatments, which may cause lasting side effects.REC name
East of England - Cambridge South Research Ethics Committee
REC reference
22/EE/0218
Date of REC Opinion
15 Nov 2022
REC opinion
Further Information Favourable Opinion