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Treatment for high-risk locally advanced prostate cancer typically includes radiation or radical prostatectomy plus androgen deprivation therapy (ADT), but the optimal use of neoadjuvant and adjuvant ADT in practice remains unclear. Relugolix and enzalutamide have demonstrated strong efficacy independently in the setting of advanced disease, but their combined use in neoadjuvant/adjuvant therapy has not been studied. This trial investigates their safety and efficacy as neoadjuvant/adjuvant therapy in patients undergoing definitive local treatment.
Relugolix and Enzalutamide as Neoadjuvant/Adjuvant to Local-regional treatment in Patients with High-risk, Locally Advanced Prostate Cancer (RENAPCA) is a prospective, single-arm, open-label phase Ib trial with blinded outcome assessment. The study is conducted across four tertiary oncology centres within the United States. Eligible participants are adult men with pathologically confirmed locally advanced high-risk prostate cancer who are candidates for definitive local therapy. Patients with significant comorbidities or a life expectancy of less than 6 months are excluded. The trial includes a 3+3 dose-escalation safety lead-in cohort (up to 12 patients) to determine dose-limiting toxicities and recommended phase 2 dose, followed by a dose expansion cohort (up to 46 patients). Interventions consist of 6 months of neoadjuvant therapy with relugolix plus enzalutamide, definitive local therapy (radical prostatectomy or radiation therapy), and 18 months of adjuvant therapy with relugolix plus enzalutamide. Primary outcomes include pathologic CR rate and minimal residual disease rate. Secondary outcomes include prostate-specific antigen response, progression-free survival, objective response rate, frequency and severity of adverse events, and positive margin/pathologic downgrade rate. Exploratory objectives include patient-reported outcomes and quality of life measures. RENAPCA will assess the safety and efficacy of neoadjuvant/adjuvant relugolix+enzalutamide in high-risk, locally advanced prostate cancer to support future larger-scale studies and potentially improve treatment outcomes.
This research protocol has been approved by the Institutional Review Board of the University of Oklahoma Health Sciences Center (7 March 2024). The study is based on voluntary participation with informed written consent.
Venous leg ulcers (VLU) account for the majority of chronic wounds, with an estimated rise in prevalence due to demographic change. Care often does not comply with evidence, and patients remain passive and uninformed. To support general practice VLU care, the ‘UlcusCrurisCare’ (UCC) project developed a multimodal intervention comprising provider training, software-supported case management and standardised patient education. Experts from the medical community (physicians, nurses, association of medical assistants), health insurance and patient representatives provided their assessment of barriers in VLU care, requirements for intervention components and their expected effects. Semi-structured interviews and questionnaires were used at two measuring points. Qualitative data analysis was based on the Theoretical Domains Framework. Quantitative data were analysed descriptively. Ten experts named a lack of knowledge and application regarding compression therapy, reluctance to assume role as primary care provider, and inadequate remuneration as barriers for evidence-based VLU care. To effectively address these barriers, interventions are required to foster the use of compression therapy and patient education. A multimodal approach such as pursued in UCC is expected to effectively address deficits in VLU care at general practitioner level by promoting provider knowledge about evidence-based treatment and supporting patient adherence.
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