Comparative healthcare research outcomes of novel Surgery in prostate cancer (IP4-CHRONOS): Pilot RCT assessing feasibility of randomization for focal therapy in localized prostate cancer.

Authors

null

Deepika Reddy

Imperial College London, London, United Kingdom

Deepika Reddy , Tim Dudderidge , Taimur Shah , Stuart McCracken , Manit Arya , Francesca Fiorentino , Emily Day , Andrew Prevost , Mark Emberton , John Staffurth , Sarbjinder Sandhu , Richard Hindley , Nim Arumainayagam , Matthew R. Sydes , Vincent Khoo , Mathias Winkler , Hashim Uddin Ahmed

Organizations

Imperial College London, London, United Kingdom, University Hospital Southampton, Southampton, United Kingdom, Prostate Cancer UK, London, United Kingdom, Sunderland Royal Hospital, London, United Kingdom, University College London Hospitals NHS Foundation Trust, London, United Kingdom, Imperial Clinical Trials Unit, Imperial College London, London, United Kingdom, King's College London, Null, United Kingdom, University College London, London, United Kingdom, Cardiff University, Cardiff, United Kingdom, Kingston Univeristy Hospital, London, United Kingdom, Hampshire Hospital NHS Trust, Basingstoke, United Kingdom, Department of Urology, Ashford and St Peters Hospitals, London, United Kingdom, Royal Marsden Hospital, London, United Kingdom, Imperial Urology, Charing Cross Hospital, Imperial College Healthcare NHS Trust, London, United Kingdom

Research Funding

Other

Background: Randomised comparative data is lacking for focal therapy in localised prostate cancer. Imperial Prostate 4 CHRONOS (IP4- CHRONOS) is an RCT designed to reflect patient and physician equipoise to maximise acceptance to randomisation. Methods: Patients and physicians could opt for CHRONOS-A or CHRONOS-B. CHRONOS-A randomised between focal therapy (HIFU/cryotherapy) and radical therapy (radiation/prostatectomy). Using a multi-arm-multistage design, CHRONOS-B randomised between focal and focal combined with neoadjuvant medication (3 months of either finasteride or bicalutamide). We report the pilot phase outcomes on feasibility of randomisation. IP4-CHRONOS had ethics committee approval and was registered (ISRCTN17796995). Results: Due to impact of COVID-19, the target for CHRONOS-A was modified from 60 to 36; 36 patients were randomised over 24 months from 7 sites (Nov/2019-Nov/2021). CHRONOS-B randomised 64 patients over 14 months across 6 sites (Dec/2019-Feb/2021). Median (IQR) age and PSA (ng/ml) for CHRONOS-A were 69 (65-72) years and 6 (5-7) and for 66 (60.5-70) years and 6 (4-7) for CHRONOS-B, respectively. 34/36 (94%) and 60/64 (94%) had ISUP Grade Group > / = 2, respectively. 4/18 (22%) randomised to radical in CHRONOS-A withdrew consent; 1/22 (5%) randomised to focal withdrew. In CHRONOS-B, only 1/21 (5%) randomised to focal alone, and another randomised to focal with neoadjuvant bicalutamide withdrew. A qualitative recruitment intervention partially improved accrual to CHRONOS-A. Conclusions: IP4-CHRONOS evaluated patient and physician equipoise regarding focal therapy. Randomising between focal and radical therapy is not feasible due to strong patient preferences. A multi-arm, multi-stage RCT investigating the role of neoadjuvant agents combined with focal therapy is feasible. Clinical trial information: 17796995.

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Abstract Details

Meeting

2022 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Genitourinary Cancer—Prostate, Testicular, and Penile

Track

Genitourinary Cancer—Prostate, Testicular, and Penile

Sub Track

Prostate Cancer–Local-Regional Disease

Clinical Trial Registration Number

17796995

Citation

J Clin Oncol 40, 2022 (suppl 16; abstr 5086)

DOI

10.1200/JCO.2022.40.16_suppl.5086

Abstract #

5086

Poster Bd #

269

Abstract Disclosures