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A study protocol for a clinical trial involving the combination of Onalespib and Abiraterone Acetate in treating castration-resistant prostate cancer.
Year: 2021
Region / City: Not specified
Topic: Clinical study, oncology, prostate cancer
Document Type: Study Protocol
Organization / Institution: Not specified
Author: Not specified
Target Audience: Medical professionals, clinical researchers
Effective Period: Not specified
Approval Date: Not specified
Modification Date: Not specified
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
Request for prior authorization for ERLEADA® treatment in metastatic castration-sensitive prostate cancer and non-metastatic castration-resistant prostate cancer patients
Year: [Insert year]
Region / city: [Insert region/city]
Subject: Medical treatment request
Document type: Authorization request letter
Institution: [Insert institution name]
Author: [Physician’s name]
Target audience: Medical/Pharmacy Director
Effective period: [Insert effective period]
Approval date: [Insert approval date]
Date of modifications: [Insert modification date]
Diagnosis: [Insert diagnosis]
Treatment: ERLEADA® (apalutamide)
Clinical trial: TITAN trial
Clinical guidelines reference: NCCN Guidelines®, AUA/SUO Guidelines
Patient history: [Insert patient history]
Risk of disease progression: [Insert risk]
Adverse reactions: Rash, hot flush, hypertension, arthralgia, pruritus
Publication reference: Journal of Clinical Oncology
Study data source: Precision Point Specialty (PPS) Analytics, Komodo Research Database
Study design: Retrospective, longitudinal, head-to-head analysis
Outcome: Overall survival at 24 months
Supplemental MaterialThe PSMA-Targeting Half-Life Extended BiTE® Therapy AMG 160 Has Potent Antitumor Activity in Preclinical Models of Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Year: 2026
Region / city: South San Francisco, CA, USA; Munich, Germany
Subject: Oncology, Cancer Research
Document type: Research Paper
Organization: Amgen Research
Author: Petra Deegen, Oliver Thomas, Olivier Nolan-Stevaux, Shyun Li, Joachim Wahl, Pamela Bogner, Famke Aeffner, Matthias Friedrich, Michael Z. Liao, Katja Matthes, Doris Rau, Benno Rattel, Tobias Raum, Peter Kufer, Angela Coxon, Julie M. Bailis
Target audience: Researchers, oncologists, biotechnologists
Period of validity: Not specified
Approval date: Not provided
Date of changes: Not provided
NHS Board Service Outline and Governance Checklist Zytiga® (Abiraterone)
Year: 2017
Region / City: UK
Theme: Oncology / Pharmaceutical
Document Type: Service Outline
Organization: NHS Scotland
Author: NHS Board
Target Audience: Healthcare professionals, pharmacists
Period of Validity: 2017–2027 (subject to patent status)
Date of Approval: 12/10/2015
Date of Last Revision: 13/08/2012
Patent Expiry Date: 2018 (possible extension until 2027)
Service Type: Patient access and prescription management for Zytiga®
Description: This document provides a service outline and governance checklist for the supply, prescription, and patient management of Zytiga® (abiraterone acetate) within NHS Scotland, focusing on its usage in treating metastatic castration-resistant prostate cancer.
Abiraterone with or without Food? A Retrospective pilot study On Determining the effect of abiraterone Intake with food on Toxicity and life-Expectancy in mCRPC patients (AFRODITE)
Year: 2022
Region / city: Netherlands
Topic: Cancer treatment, Abiraterone, Prostate cancer
Document type: Research study
Institution: Ziekenhuis Gelderse Vallei, Radboudumc
Author: Indy Murdoch, Emmy Boerrigter, Arnold Baars, Floor Lubberman
Target audience: Healthcare professionals, Researchers
Period of validity: N/A
Date of approval: February 4, 2022
Date of changes: N/A
FINAL APPRAISAL DOCUMENT FOR ABIRATERONE FOR HIGH-RISK HORMONE-SENSITIVE METASTATIC PROSTATE CANCER, 21 July 2020
Year: 2020
Organization: National Institute for Health and Care Excellence (NICE)
Corresponding Group: British Uro-Oncology Group (BUG)
Document Type: Final Appraisal Document
Subject: Abiraterone, Hormone-Sensitive Metastatic Prostate Cancer
Recipient: STAMPEDE Trial Chief Investigator
Date of Letter: 21 July 2020
Period Covered: Initial appraisal and appeal process regarding abiraterone
Appeal Grounds: Unreasonableness of recommendations based on submitted evidence
Key Topics: Clinical effectiveness, cost-effectiveness, follow-on treatments, quality of life, impact of COVID-19
Document Format: Letter with appraisal commentary and appeal guidance
National Institute for Health and Care Excellence Single Technology Appraisal Appeal Hearing Advice on abiraterone for treating newly diagnosed metastatic hormone-naïve prostate cancer [ID945] Decision of the Panel
Year: 2020
Region / City: United Kingdom
Topic: Prostate Cancer, Oncology, Drug Evaluation
Document Type: Appeal Hearing Transcript
Organization: National Institute for Health and Care Excellence (NICE)
Author: Various panel members, including Heather Blake, Professor Nicholas James, and others
Target Audience: Healthcare professionals, decision-makers, cancer advocacy groups
Effective Period: September 2020
Approval Date: 3 September 2020
Date of Changes: None
Appeal Against the Final Appraisal Determination for Abiraterone in High-Risk Hormone-Sensitive Metastatic Prostate Cancer
Year: 2020
Region / Country: United Kingdom
Subject: Health technology appraisal, oncology, prostate cancer
Document Type: Legal/administrative appeal
Organization: National Institute for Health and Care Excellence (NICE)
Author: Janssen Pharmaceuticals
Target Audience: Healthcare regulators, appraisal committees, oncology specialists
Treatment Indication: Newly diagnosed high-risk metastatic hormone-sensitive prostate cancer in adult men
Therapy Discussed: Abiraterone in combination with androgen deprivation therapy (ADT)
Procedural History: Referral in 2016, European Commission approval in 2017, Final Appraisal Determination issued 19 June 2020
Patent Status: Patent expiration expected September 2022, generic versions available in the USA
Appeal Grounds: Clinical benefit assessment, quality of life considerations, cost-effectiveness evaluation, procedural fairness
Topics: Onalespib castration-resistant Abiraterone