A 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.
| cam.depositDate | 2022-01-12 | |
| cam.orpheus.counter | 2 | |
| dc.contributor.author | Barrett, Tristan | |
| dc.contributor.author | Pacey, Simon | |
| dc.contributor.author | Leonard, Kelly | |
| dc.contributor.author | Wulff, Jerome | |
| dc.contributor.author | Funingana, Gabriel | |
| dc.contributor.author | Gnanapragasam, Vincent | |
| dc.contributor.orcid | Barrett, Tristan [0000-0002-1180-1474] | |
| dc.contributor.orcid | Pacey, Simon [0000-0002-3303-7577] | |
| dc.contributor.orcid | Funingana, Gabriel [0000-0002-1197-2652] | |
| dc.contributor.orcid | Gnanapragasam, Vincent [0000-0003-4722-4207] | |
| dc.date.accessioned | 2022-01-14T00:30:40Z | |
| dc.date.available | 2022-01-14T00:30:40Z | |
| dc.date.issued | 2022-04 | |
| dc.date.updated | 2022-01-12T14:31:58Z | |
| dc.description.abstract | Background: 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.sponsorship | Janssen unrestricted education grant | |
| dc.identifier.doi | 10.17863/CAM.80137 | |
| dc.identifier.eissn | 2666-1683 | |
| dc.identifier.issn | 2666-1691 | |
| dc.identifier.uri | https://www.repository.cam.ac.uk/handle/1810/332693 | |
| dc.language.iso | eng | |
| dc.publisher | Elsevier BV | |
| dc.publisher.department | Department of Surgery | |
| dc.rights | Attribution-NonCommercial-NoDerivatives 4.0 International | |
| dc.rights.uri | https://creativecommons.org/licenses/by-nc-nd/4.0/ | |
| dc.title | A 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.type | Article | |
| dcterms.dateAccepted | 2022-01-18 | |
| prism.publicationName | Eur Urol Open Sci | |
| pubs.licence-display-name | Apollo Repository Deposit Licence Agreement | |
| pubs.licence-identifier | apollo-deposit-licence-2-1 | |
| rioxxterms.type | Journal Article/Review | |
| rioxxterms.version | VoR | |
| rioxxterms.versionofrecord | 10.1016/j.euros.2022.01.007 |
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