Onderzoek naar kwaliteit van leven en zorggebruik bij gevorderde prostaat kanker

Completed

Conditions: Castration-resistant prostate cancer

Registration Number: NL-OMON27164

Lead Sponsor: sponsor Erasmus University Rotterdam, Institute for Medical Technology Assessment address PO Box 1738 postal code 3000 DR city Rotterdam country The Netherlands phone +31 10 408 8696 fax email office.hta@eshpm.eur.nl

Brief Summary: M Kuppen, H Westgeest, A Van den Eertwegh, R Van Moorselaar, N Mehra, J Coenen, I Van Oort, A Van den Bergh, K Aben, D Somford, J Lavalaye, W Gerritsen, C Uyl-de Groot; Patient reported outcomes in the castration resistant prostate cancer registry (PRO-CAPRI). PCN388, 21th Annual European Congress ISPOR Barcelona, 2018. Kuppen M, Westgeest H, Van Den Eertwegh A, Coenen J, Van Moorselaar R, Van Den Berg P, Geenen M, Mehra N, Hendriks M, Lampe M, Van De Luijtgaarden A, Peters F, Roeleveld T, Smilde T, De Wit R, Van Oort I, Gerritsen W, Uyl-De Groot C; Health-related Quality of Life and Pain in a Real-world Castration-resistant Prostate Cancer Population: Results From the PRO-CAPRI Study in the Netherlands. Clin Genitourin Cancer 2019 Dec 5. pii: S1558-7673(19)30366-0. doi: 10.1016/j.clgc.2019.11.015. [Epub ahead of print]

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 200

Inclusion Criteria

Two populations are eligible for inclusion:

1. Patients newly diagnosed with CRPC. CRPC is defined by either the treating doctor/physician, or by the definition (prostate cancer that is progressing despite medical or surgical castration (i.e. castrate levels of testosterone (¡Ü 50 ng/dL or <1,7 nmol/L). If no testosterone has been measured, treatment with surgical castration or medical castration (LHRH-agonists or ¨Cantagonists) has to be initiated prior to progression of prostate cancer. Because anti-androgen withdrawal response may occur in patients treated with combined androgen blockade (medical or surgical castration plus continuous anti-androgen), progression must be evaluated after discontinuation of anti-androgens for 4 to 8 weeks. Progression is defined as either
progression according to the treating doctor/physician; or PSA progression, that is two rising PSA values at a minimum of 1-week intervals with a minimum starting value of 2,0 ng/ml; or radiologic progression, that is the appearance of two or more new lesions on bone scintigraphy or measurable disease (local or nodal or visceral progression)).

2. Patients diagnosed with CRPC after 1-1-2010 and now start the first post-docetaxel treatment line.

Exclusion Criteria

N/A

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the HRQOL at baseline and changes over time during CRPC treatment<br /><br>a. generic HRQOL by EQ VAS score and EQ-5D index value<br /><br>b. cancer specific HRQOL by EORTC QLQ-C30 score<br /><br>c. prostate cancer specific HRQOL by EORTC QLQ-PR25 score

Secondary Outcome Measures

Name	Time	Method
To determine<br>a. indirect non-medical costs during CRPC treatment (productivity losses due to absenteeism)<br>b. direct medical costs outside the hospital during CRPC treatment (medical resource use outside the hospital and informal care)<br>c. self-reported pain by BPI-SF pain severity and interference