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dc.contributor.authorBarrett, Tristan
dc.contributor.authorPacey, Simon
dc.contributor.authorLeonard, Kelly
dc.contributor.authorWulff, Jerome
dc.contributor.authorFuningana, Gabriel
dc.contributor.authorGnanapragasam, Vincent
dc.date.accessioned2022-01-14T00:30:40Z
dc.date.available2022-01-14T00:30:40Z
dc.date.issued2022-04
dc.identifier.issn2666-1691
dc.identifier.urihttps://www.repository.cam.ac.uk/handle/1810/332693
dc.description.abstractBackground: Active surveillance (AS) is a preferred management option for men with prostate cancer with favourable prognosis. However, nearly half of men on AS switch to treatment within 5 years, so therapeutic strategies to prevent or delay disease progression could be considered. The androgen receptor is the pre-eminent oncogenic driver in prostate cancer. Objective: To explore image-based tumour responses and the patient impact of short-duration androgen-targeted therapy (ATT) to abrogate disease progression during AS. Design setting and participants: Men on AS with Cambridge Prognostic Group 1 & 2 (low and favourable intermediate risk) prostate cancer and lesions visible on magnetic resonance imaging (MRI) were recruited to an open-label, single-centre, phase 2 feasibility study of short-term ATT (the TAPS01 study). Intervention: Apalutamide 240 mg was administered for 90 days. Outcome measurements and statistical analysis: MRI-measured tumour volume (TV), gland volume (GV), and the TV/GV ratio were calculated at baseline, at day 90 (end of treatment), and at 6- and 18-month follow-up. Quality of life metrics were measured at day 0, day 90, and 6 weeks after ATT. Results and limitations: Eleven patients (40% of eligible men approached) agreed to participate, of whom nine completed treatment. At day 90, the median percentage reduction was -38.2% (range -51.8% to -23.5%) for GV, -54.2% (range -74.1% to -13.8%) for TV, and -27.2% (range -61.5% to -7.5%) for TV/GV (all p < 0.0001). At 6 mo, while GV had returned to baseline (p = 0.95) both TV (-31.9%; p = 0.0007) and TV/GV (-28.7%; p = 0.0009) remained significantly reduced. This reduction was sustained at 18 months (TV -18%, TV/GV -23.8%; p = 0.01). European Organization for Research and Treatment of Cancer QoL core 30-item questionnaire scores for global, physical, role, and social functioning decreased during treatment, but all were recovering by 6 weeks. EQ-VAS scores were unchanged compared to baseline. Conclusions: TAPS01 has demonstrated feasibility and patient tolerability for short-term ATT in men on AS. Our data suggest a selective and durable antitumour effect in the short term and support a larger-scale randomised trial. Patient summary: We investigated the feasibility of short-term treatment with an androgen inhibitor to prevent or delay disease progression for men on active surveillance for prostate cancer. Results for a small group of patients show that 90-day treatment led to a sustained decrease in tumour volume over 18 months. The findings warrant a larger clinical trial for this approach, which could allow patients to delay or even avoid longer-term active treatments.
dc.description.sponsorshipJanssen unrestricted education grant
dc.publisherElsevier BV
dc.rightsAttribution-NonCommercial-NoDerivatives 4.0 International
dc.rights.urihttps://creativecommons.org/licenses/by-nc-nd/4.0/
dc.titleA Feasibility Study of the Therapeutic Response and Durability of Short-term Androgen-targeted Therapy in Early Prostate Cancer Managed with Surveillance: The Therapeutics in Active Prostate Surveillance (TAPS01) Study.
dc.typeArticle
dc.publisher.departmentDepartment of Surgery
dc.date.updated2022-01-12T14:31:58Z
prism.publicationNameEur Urol Open Sci
dc.identifier.doi10.17863/CAM.80137
dcterms.dateAccepted2022-01-18
rioxxterms.versionofrecord10.1016/j.euros.2022.01.007
rioxxterms.versionVoR
dc.contributor.orcidBarrett, Tristan [0000-0002-1180-1474]
dc.contributor.orcidPacey, Simon [0000-0002-3303-7577]
dc.contributor.orcidFuningana, Gabriel [0000-0002-1197-2652]
dc.contributor.orcidGnanapragasam, Vincent [0000-0003-4722-4207]
dc.identifier.eissn2666-1683
rioxxterms.typeJournal Article/Review
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cam.depositDate2022-01-12
pubs.licence-identifierapollo-deposit-licence-2-1
pubs.licence-display-nameApollo Repository Deposit Licence Agreement


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Attribution-NonCommercial-NoDerivatives 4.0 International
Except where otherwise noted, this item's licence is described as Attribution-NonCommercial-NoDerivatives 4.0 International