CLINICAL FOLLOW-UP OF TAPS01 SUBJECTS- A PROSPECTIVE STUDY
Research type
Research Study
Full title
CLINICAL FOLLOW-UP OF TAPS01 SUBJECTS- A PROSPECTIVE STUDY
IRAS ID
277201
Contact name
VINCENT JEYASEELAN GNANAPRAGASAM
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge
Duration of Study in the UK
4 years, 11 months, 28 days
Research summary
There is sufficient evidence that pharmacological intervention used as short-term therapy in men with low to intermediate-risk disease can inhibit the growth of prostate tumours and delay or remove the need for radical therapy in men managed by active surveillance. The TAPS01 window study was based on the known anti-androgen effects of apalutamide and investigates the efficacy of using it as a short intervention strategy to cause a physiological change in the tumour by reducing its volume. Tumour volume was measured using the well-established place of mpMRI defined tumour volumes as a surrogate of disease presence and change.
We would like to do a clinical follow-up of the 9 TAPS01 subjects and record changes in PSA, MRI assessments, histology and changes in treatment modality.REC name
London - Westminster Research Ethics Committee
REC reference
20/LO/0264
Date of REC Opinion
20 Apr 2020
REC opinion
Further Information Favourable Opinion