IP17-APOLLO
Research type
Research Study
Full title
IP17- Apalutamide prior to Prostate ablation Of focal Lesions in patients with LOcalised prostate cancer
IRAS ID
1013250
Contact name
Taimur Shah
Contact email
Sponsor organisation
Imperial College London
Research summary
Men diagnosed with significant prostate cancer, confined to the prostate, are increasingly undergoing focal therapy rather than traditional radical treatments such as whole-gland surgery or radiotherapy. Focal therapy is a targeted treatment for prostate cancer and thus it not only minimises damage to surrounding tissue, it also results in lower side-effects than traditional treatments. Just like any cancer treatment, some patients cancer will return (recurrence). A potential solution would be to use drugs prior to the focal therapy (neo-adjuvant treatment) which would maintain the low side effects from treatment whilst improving its efficacy and reducing the recurrence rate.
Apalutamide is a hormone therapy that targets the testosterone pathway and has been shown to shrink cancers. We believe that using Apalutamide prior to focal therapy may improve outcomes further for men that receive focal therapy. There have, however, been no randomised control trials (RCTs) assessing the improvement of cancer control outcomes in patients that undergo focal therapy alone versus focal therapy with Apalutamide. By using the APOLLO study, we aim to answer this question.
To answer this question, we have designed a randomised control trial with an embedded pilot study aimed at comparing the cancer control outcomes of neoadjuvant Apalutamide followed by focal therapy with focal therapy alone. Janssen Cilag Ltd (who manufacture Apalutamide) are funding the initial pilot stage of the study and will be supplying Apalutamide free of charge. Men with localised prostate cancer who are due to undergo focal therapy as part of their care will be eligible for APOLLO. We aim to open 20 sites (10 initially within the pilot study) across the UK to aid in recruitment for this study. The internal pilot will run for 2 years and with the main study, the total duration will be 6 years.
REC name
Wales REC 2
REC reference
26/WA/0013
Date of REC Opinion
11 Feb 2026
REC opinion
Further Information Favourable Opinion