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. 2021 Aug 9:bmjspcare-2021-002994.
doi: 10.1136/bmjspcare-2021-002994. Online ahead of print.

Advanced prostate cancer experimental radioactive treatment-clinical trial decision making: patient experiences

Bianca Viljoen  1 , Michael S Hofman  2   3 , Suzanne K Chambers  4   5   6   7   8 , Jeff Dunn  6   7 , Haryana Dhillon  9 , Ian D Davis  10   11 , Nicholas Ralph  12   4   6
Affiliations

Advanced prostate cancer experimental radioactive treatment-clinical trial decision making: patient experiences

Bianca Viljoen et al. BMJ Support Palliat Care. .

Abstract

Objectives: Nested qualitative studies within clinical trials provide the opportunity to better understand participant experiences of participation and identify areas where improved support is required. The purpose of this qualitative study is to describe the lived experiences of men with advanced prostate cancer participating in the TheraP trial; a randomised trial of 177Lu-PSMA-617 compared with cabazitaxel chemotherapy.

Methods: Fifteen men with advanced prostate cancer were recruited from the TheraP clinical trial and interviewed at three time points during the trial. Interviews were inductively analysed using thematic analysis. This research paper reports the results from the baseline interview at commencement of the trial, focusing specifically on participants' enrolment experiences.

Results: Four themes were identified representing the lived experiences of men with advanced prostate cancer deciding to participate in the TheraP trial: (1) hoping to survive; (2) needing to feel informed; (3) choosing to participate and (4) being randomised. The process of deciding to enrol in a clinical trial is filled with indecision, emotional difficulties and focused on a desire to live.

Conclusions: For men with advanced prostate cancer, the experience of deciding to enrol in a clinical trial is principally driven by a desire to survive but interlinked with the need to make an informed decision as participants in this study expressed a preference for allocation to the experimental arm. Men seeking to enrol in clinical trials of new prostate cancer treatments would benefit from improved informational and decision support.

Trial registration number: NCT03392428, ANZUP1603.

Keywords: clinical decisions; prostate; supportive care.

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Conflict of interest statement

Competing interests: Authors report no direct relevant competing interests. MSH reports grants from Movember, Prostate Cancer Foundation of Australia, Endocyte (a Novartis Company), Peter MacCallum Foundation and non-financial support from ANSTO, during the conduct of the study; grants from Prostate Cancer Foundation, Movember, Prostate Cancer Foundation of Australia, US Department of Defence; personal fees from Janssen, Sanofi Genzyme, Mundipharma, Astellas, Merck/MSD, outside the submitted work. IDD reports grants from National Health and Medical Research Council, during the conduct of the study; institutional payments to support prostate cancer trials from Pfizer, ANZUP Cancer Trials Group, Bayer, Astellas, Janssen, Movember Foundation, Merck Sharp & Dohme outside the submitted work; unremunerated chair of ANZUP Cancer Trials Group. Other authors declare there are no competing interests.

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