Background: Patient-facing digital technologies (also called "Patient Technology" [PT]) have the potential to serve a variety of functions in clinical trials, such as capturing clinical endpoints, engaging patients, and facilitating remote study conduct. However, these technologies are not yet accepted as mainstream research tools, and the opportunities, challenges, and facilitators associated with their implementation in clinical trials have not been fully characterized. Methods: In order to understand the factors affecting PT adoption, the TransCelerate Patient Technology Initiative conducted a series of surveys, interviews, and focus groups with approximately 600 subject matter experts, including pharmaceutical company representatives, clinical trial investigators at a number of trial sites worldwide, and clinical trial participants. All interview and survey responses were blinded and aggregated by a third-party consultant and themes were extracted. Results: There was general consensus around the potential value of patient-facing technology as a clinical research tool, though a variety of challenges faced by each stakeholder were discussed. Detailed accounts of opportunities (improved patient experience, compliance, and engagement; clinical trial efficiencies; improved data quality and insights) and barriers (organizational and corporate cultural challenges, business-related challenges, user willingness and burden, and regulatory challenges) are reported. Conclusions: While the barriers to PT adoption explored here were numerous, they were also generally consistent. A number of proposals for establishing more holistic, collaborative, and strategic approaches to PT implementation in clinical trials are discussed. Such approaches could facilitate more effective, widespread adoption of PT, and thereby a more patient-centric clinical trial paradigm.

External factors, such as the coronavirus disease 2019 (COVID-19), can lead to cancellations and backlogs of cancer surgeries. The effects of these delays are unclear. This study summarised the evidence surrounding expectant management, delay radical prostatectomy (RP), and neoadjuvant hormone therapy (NHT) compared to immediate RP. MEDLINE and EMBASE was searched for randomised controlled trials (RCTs) and non-randomised controlled studies pertaining to the review question. Risks of biases (RoB) were evaluated using the RoB 2.0 tool and the Newcastle–Ottawa Scale. A total of 57 studies were included. Meta-analysis of four RCTs found overall survival and cancer-specific survival were significantly worsened amongst intermediate-risk patients undergoing active monitoring, observation, or watchful waiting but not in low- and high-risk patients. Evidence from 33 observational studies comparing delayed RP and immediate RP is contradictory. However, conservative estimates of delays over 5 months, 4 months, and 30 days for low-risk, intermediate-risk, and high-risk patients, respectively, have been associated with significantly worse pathological and oncological outcomes in individual studies. In 11 RCTs, a 3-month course of NHT has been shown to improve pathological outcomes in most patients, but its effect on oncological outcomes is apparently limited.

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INTRODUCTION AND OBJECTIVE: Adopting an MRI first approach in prostate cancer diagnostic pathway has helped in decreasing the number of unnecessary prostate biopsies. Guidelines still recommend performing both targeted biopsy (TBx) and systematic biopsies (SBx) even when a lesion is detected in MRI. The prospect of doing only TBx if a definite lesion is seen in MRI is desirable as this decreases the morbidity of the procedure. However this has to be balanced against the risk of missing clinically significant prostate cancer (csPCa). We examined the data of our local anaesthetic transperineal (LATP) prostate biopsies, with MRI scan scores of PIRADS 4 & 5 and targetable lesion, and analysed the percentage of csPCa that would have been missed if only TBx were performed.METHODS: We retrospectively collected the data of 650 patients who underwent LATP biopsies in our institute from February 2019 to July 2022. 329 patients had MRI score of PIRADS 4 or 5. All these patients had SBx and TBx according to the Ginsburg TP protocol. For MRI targetable lesions a four core cognitive guidance TBx was done per target. csPCa was defined as ISUP grade group 2 or more.RESULTS: 329 patients had MRI score of PIRADS 4 or 5. 245 (74.5%) had targetable lesion and underwent both TBx and SBx. Both TBx and SBx were positive for csPCa in 39.6% (97/245). Both TBx and SBx didn't show csPCa in 46.1% (113/245). In 5.7% (14/245), TBx showed csPCa when SBx was negative. In 8.6% (21/245), csPCa detected by SBx was missed by TBx. 15.9% (21/132) csPCa would have been missed if only TBx was performed for PIRADS 4 & 5 with an MRI targetable lesion. The sensitivity of TBx in this study was 82.2%, with specificity of 89.0% and a negative predictive value of 84.3%.CONCLUSIONS: his study from a high-volume centre suggests that adopting the TBx-only approach for MRI targetable lesions continues to miss a significant level of csPCa. Therefore adopting this strategy remains debatable