KEY TAKEAWAYS
- The NCT03392428 TheraP study is a randomized, 2-arm, phase 2, stratified study into the efficacy of 177Lu-PSMA617 drug compared to Cabazitaxel in treating mCRPC.
- Male patients of 18 years or older with metastatic adenocarcinoma of the prostate and PSA ≥ 20 ng/mL were eligible to participate in this study.
- These participants were interviewed multiple times during the study so that Patient Reported Outcomes could be analyzed.
- The analysis of the PROs showed that the patients needed psychological and supportive care.
Qualitative studies are required in clinical trials to understand the therapy process, how it changes over time, and the areas needing better supportive care. This qualitative research aimed to describe the lived experiences of men with advanced prostate cancer participating in the TheraP trial, a randomized trial comparing the chemotherapy drug cabazitaxel with the radiotracer 177Lu-PSMA-617.
The TheraP trial demonstrated that therapy with lutetium-177 [177Lu]Lu-PSMA-617 increased the frequency of PSA response rate and progression-free survival in males. During the study, 15 men with advanced prostate cancer were interviewed thrice at different times (follow-up, midpoint, and final interviews). The interviews were then analyzed thematically using an interpretative phenomenological method.
This qualitative approach put particular emphasis on the trial participants’ experiences. It revealed that the participants in the TheraP trial experienced three main themes. The first of which was that they had fewer choices. Another common theme was that they were anticipating the outcome. And the third theme was that they were coping with the health changes.
Men who participate in anti-neoplastic treatment clinical trials for prostate cancer require specialized psychological and supportive care, paying particular attention to the unique experiences of having prostate cancer and participating in clinical trials. Men with advanced prostate cancer should routinely have their survivorship requirements assessed. They should be able to make informed decisions with the support and the services for ongoing care. They must be supported throughout their disease as part of their trial experience.
Source: https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0276063
Clinical Trial: https://clinicaltrials.gov/ct2/show/NCT03392428
Viljoen, B., Hofman, M. S., Chambers, S. K., Dunn, J., Dhillon, H. M., Davis, I. D., & Ralph, N. (2022). Experiences of participants in a clinical trial of a novel radioactive treatment for advanced prostate cancer: A nested, qualitative longitudinal study. PloS one, 17(11), e0276063. https://doi.org/10.1371/journal.pone.0276063
