This information is intended for US healthcare professionals to access current scientific information about J&J Innovative Medicine products. It is prepared by Medical Information and is not intended for promotional purposes, nor to provide medical advice.
summary
- APA-RP (NCT04523207) was a phase 2, open-label, single-arm, multicenter study that evaluated the efficacy and safety of adjuvant treatment with ERLEADA and androgen deprivation therapy (ADT) in treatment-naïve patients with high-risk localized prostate cancer who have undergone radical prostatectomy (RP; N=108).1,2
- Use of a prespecified rash management guide outlining proactive steps for medical management of rash and patient education on gentle skin care was implemented for patients enrolled in the study, with the intent to reduce the onset and severity of rash events. Rash-related safety data were collected during the first 12 months following initation of ERLEADA treatment and compared descriptively with the North American patient populations of the global SPARTAN and TITAN studies.3
- The infographic on pages 2-3 provide the rash management guide and the rash-related safety data results.
Rash Management Guide
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1 | Shore N, Hafron J, Saltzstein D, et al. Apalutamide for high-risk localized prostate cancer following radical prostatectomy (Apa-RP). [published online ahead of print August 01, 2024]. J Urol. doi:10.1097/ju.0000000000004163. |
2 | Janssen Research & Development LLC. A study of apalutamide (adjuvant treatment) and androgen deprivation therapy (ADT) in participants who have undergone radical prostatectomy (RP) for non-metastatic prostate cancer and who are at high risk for metastases. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2020- [cited 2024 August 05]. Available from: https://clinicaltrials.gov/study/NCT04523207 NLM Identifier: NCT04523207. |
3 | Shore N, Hafron J, Saltzstein D, et al. Impact of a rash management guide in patients receiving apalutamide for high-risk localized prostate cancer in the Apa-RP study. [published online ahead of print July 05, 2024]. Prostate Cancer Prostatic Dis. doi:10.1038/s41391-024-00858-4. |