Experiences of participants in a clinical trial of a novel radioactive treatment for advanced prostate cancer: A nested, qualitative longitudinal study

PLoS One. 2022 Nov 9;17(11):e0276063. doi: 10.1371/journal.pone.0276063. eCollection 2022.


Objectives: Qualitative studies nested within clinical trials can provide insight into the treatment experience, how this evolves over time and where improved supportive care 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 with interviews conducted at three timepoints during the trial. An interpretative phenomenological approach was used, and interviews analysed using thematic analysis. This research paper reports the results from the mid-point, conclusion and follow up interviews, focusing specifically on participants' experiences of trial participation.

Results: Three themes were identified representing the lived experiences of men with advanced prostate cancer participating in the TheraP trial: (1) facing limited options; (2) anticipating outcomes and (3) coping with health changes.

Conclusions: Men who enrol in clinical trial of anti-neoplastic treatments for prostate cancer need targeted psychological and supportive care that includes attention to unique aspects of the experience of having prostate cancer and being in a clinical trial. As part of their trial experience, men with advanced prostate cancer need to be regularly assessed for survivorship needs, fully informed, supported and referred to services for regular care and support across the trajectory of their disease.

Trial registration: NCT03392428. Registered on 8 January 2018 (ANZUP1603).

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adaptation, Psychological
  • Humans
  • Longitudinal Studies
  • Male
  • Prostatic Neoplasms* / drug therapy
  • Prostatic Neoplasms* / psychology
  • Prostatic Neoplasms* / radiotherapy
  • Qualitative Research
  • Survivorship

Associated data

  • ClinicalTrials.gov/NCT03392428

Grant support

Funding support was received from a ANZUP Below the Belt Grant (QualTheraP: a nested, multi-perspective longitudinal qualitative study of participants) (MSH, SKC, JD, HMD, IDD, NR). The National Health and Medical Research Council (NHMRC) Centre of Research Excellence provided further funding support through a PhD Scholarship (BV). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.