Description:

ADVANCED PROSTATE CANCER DATA COLLECTION Version 2.3.1 Revised: April 10th, 2017 International Consortium for Health Outcomes Measurement (ICHOM), Source: http://www.ichom.org/ Conditions: All patients with advanced prostate cancer, either having metastatic disease or biochemical recurrence progressing after salvage treatment or ineligible for salvage treatment. Patients with biochemical recurrence treated with salvage therapy are referred to the localized prostate cancer set. Treatment Approaches: Hormonal Therapy | Chemotherapy | Immunotherapy | Radiopharmaceuticals | Radiation | Interventions for Complications of Local Progression This form contains clinical and administrative variables. To be assessed 1 year post (initial) treatment and annually for life from then on. Questionnaires used in this standard set: Expanded Prostate Cancer Index Composite (EPIC-26): The EPIC-26 is free for all health care organizations, and a license is not needed. The scoring guide may be found at http://www.med.umich.edu/urology/research/EPIC/EPIC-26-Scoring-1.2007.pdf ; Wei J, Dunn R, Litwin M, Sandler H, and Sanda M. "Development and Validation of the Expanded Prostate Cancer Index Composite (EPIC) for Comprehensive Assessment of Health-Related Quality of Life in Men with Prostate Cancer", Urology. 56: 899-905, 2000. For registries choosing to implement the EPIC‐CP rather than the EPIC‐26, we recommend using the same variable IDs as the corresponding EPIC‐26 questions. This means that only questions 2, 3, 4a, 4b, 4d, 4e, 5, 6e, 6b, 7, 8b, 9, 12, 13a, 13c, and 13d of the EPIC-26 are administered. Utilization of Sexual Medications/Devices: The Utilization of Sexual Medications/Devices is free for all health care organizations, and a license is not needed (according to ICHOM). Refer to http://dx.doi.org/10.1016/j.urology.2006.01.077 for more information European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30): For use of the EORTC QLQ-C30 a license is needed, therefore the questions will not be part of this version of the standard set. (eortc.be) The following paper has been published about development of this standard set: Morgans AK, van Bommel ACM, Stowell C, Abrahm JL, Basch E, Bekelman JE, et al. Development of a Standardized Set of Patient-centered Outcomes for Advanced Prostate Cancer: An International Effort for a Unified Approach. Eur Urol. 2015 Nov;68(5):891–8. For the standard set ICHOM has been supported by the Movember Foundation.

Link:

http://www.ichom.org/

Keywords:
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  1. 11/29/18
Copyright Holder:
ICHOM
Uploaded on:

November 29, 2018

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Creative Commons BY-NC 3.0
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ICHOM Advanced Prostate Cancer

Follow-Up Clinical Form

  1. StudyEvent: ODM
    1. Follow-Up Clinical Form
Administrative Data
Treatment Variables
Indicate if the patient received Androgen Deprivation Therapy
DD/MM/YYYY
DD/MM/YYYY
Indicate if Androgen Deprivation Therapy is ongoing
Indicate if the patient received hormonal treatment other than Androgen Deprivation Therapy
DD/MM/YYYY
DD/MM/YYYY
Indicate if hormonal therapy is ongoing
Indicate if the patient received chemotherapy
DD/MM/YYYY
DD/MM/YYYY
Indicate if chemotherapy is ongoing
Indicate if the patient received immunotherapy
DD/MM/YYYY
DD/MM/YYYY
Indicate if immunotherapy is ongoing
Indicate if the patient received radiopharmaceuticals
DD/MM/YYYY
DD/MM/YYYY
Indicate if radiotherapy is ongoing
Indicate if the patient received interventions for complications due to local progression 1 = TURP (transurethral resection of the prostate)
Indicate if the patient received interventions for complications due to local progression 2 = Ureteral stent
Indicate if the patient received interventions for complications due to local progression 3 = Percutaneous nephrostomy tube
Indicate if the patient received interventions for complications due to local progression 4 = Suprapubic catheter placement
Indicate if the patient received interventions for complications due to local progression 5 = Chronic foley catheter / self intermittent catheterization
DD/MM/YYYY
DD/MM/YYYY
DD/MM/YYYY
DD/MM/YYYY
DD/MM/YYYY
Indicate if the patient received bisphosphonates or denosumab
DD/MM/YYYY
DD/MM/YYYY
Indicate if bisphosphonates or denosumab are ongoing
Acute Complications of Treatment
Indicate whether the patient experienced a CTCAE v 4.0 grade III-IV complication while on therapy and within 6 months after initiating treatment 0 = No grade III-IV toxicity
Indicate whether the patient experienced a CTCAE v 4.0 grade III-IV complication while on therapy and within 6 months after initiating treatment 1 = Cytopenias (anemia, neutropenia, thrombocytopenia)
Indicate whether the patient experienced a CTCAE v 4.0 grade III-IV complication while on therapy and within 6 months after initiating treatment 2 = Infection, any primary site
Indicate whether the patient experienced a CTCAE v 4.0 grade III-IV complication while on therapy and within 6 months after initiating treatment 3 = Vomiting, diarrhea, constipation, other GI toxicity
Indicate whether the patient experienced a CTCAE v 4.0 grade III-IV complication while on therapy and within 6 months after initiating treatment 4 = Neuropathy, any type
Indicate whether the patient experienced a CTCAE v 4.0 grade III-IV complication while on therapy and within 6 months after initiating treatment 5 = Cardiovascular toxicity (heart attack, heart failure, arrhythmia)
Indicate whether the patient experienced a CTCAE v 4.0 grade III-IV complication while on therapy and within 6 months after initiating treatment 888 = Other (free text)
DD/MM/YYYY
DD/MM/YYYY
DD/MM/YYYY
DD/MM/YYYY
DD/MM/YYYY
DD/MM/YYYY
Degree of Health
Indicate the ECOG/WHO performance status
Survival and disease control
Indicate if patient received any of the following procedures for local progression: 0 = None of the procedures
Indicate if patient received any of the following procedures for local progression: 1 = TURP (transurethral resection of the prostate)
Indicate if patient received any of the following procedures for local progression: 2 = Ureteral stent
Indicate if patient received any of the following procedures for local progression: 3 = Percutaneous nephrostomy tube
Indicate if patient received any of the following procedures for local progression: 4 = Suprapubic catheter placement
Indicate if patient received any of the following procedures for local progression: 5 = Chronic foley catheter / self intermittent catheterization
Indicate if the patient has a symptomatic fracture, cord compression or need for surgery or radiation to bone
DD/MM/YYYY
Indicate if the patient was diagnosed with metastatic disease
DD/MM/YYYY
Indicate if the patient was diagnosed with castration resistant disease
DD/MM/YYYY
Indicate if the patient has died
DD/MM/YYYY
Indicate if death is noted to be directly attributable to prostate cancer