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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05761093
Other study ID # CRE-2022.301
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 7, 2022
Est. completion date December 31, 2024

Study information

Verified date February 2024
Source Chinese University of Hong Kong
Contact Chi Fai NG, MD
Phone 35052625
Email ngcf@surgery.cuhk.edu.hk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The objective of this study is to examine the preference weightings in term of risk/ benefit attributes of treatment in physician and prostate cancer patients from different stages of disease.


Recruitment information / eligibility

Status Recruiting
Enrollment 306
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: - aged 18 years or older, - diagnosis of metastatic prostate cancer within 5 years, - able to read and write, - accepting and signing the informed consent Exclusion Criteria: - if patients are unable to complete the survey by themselves due to physical or psychological reasons, - deemed ineligible by treating physicians if patients are unable to complete the survey by themselves due to physical or psychological reasons, - deemed ineligible by treating physicians

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Hong Kong Prince of Wales Hospital Sha Tin

Sponsors (1)

Lead Sponsor Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (8)

Aning JJ, Wassersug RJ, Goldenberg SL. Patient preference and the impact of decision-making aids on prostate cancer treatment choices and post-intervention regret. Curr Oncol. 2012 Dec;19(Suppl 3):S37-44. doi: 10.3747/co.19.1287. — View Citation

Feldman-Stewart D, Brundage MD, Van Manen L, Svenson O. Patient-focussed decision-making in early-stage prostate cancer: insights from a cognitively based decision aid. Health Expect. 2004 Jun;7(2):126-41. doi: 10.1111/j.1369-7625.2004.00271.x. — View Citation

Fizazi K, Shore N, Tammela TL, Ulys A, Vjaters E, Polyakov S, Jievaltas M, Luz M, Alekseev B, Kuss I, Kappeler C, Snapir A, Sarapohja T, Smith MR; ARAMIS Investigators. Darolutamide in Nonmetastatic, Castration-Resistant Prostate Cancer. N Engl J Med. 2019 Mar 28;380(13):1235-1246. doi: 10.1056/NEJMoa1815671. Epub 2019 Feb 14. Erratum In: N Engl J Med. 2022 Sep 1;387(9):860. — View Citation

Gravis G, Fizazi K, Joly F, Oudard S, Priou F, Esterni B, Latorzeff I, Delva R, Krakowski I, Laguerre B, Rolland F, Theodore C, Deplanque G, Ferrero JM, Pouessel D, Mourey L, Beuzeboc P, Zanetta S, Habibian M, Berdah JF, Dauba J, Baciuchka M, Platini C, Linassier C, Labourey JL, Machiels JP, El Kouri C, Ravaud A, Suc E, Eymard JC, Hasbini A, Bousquet G, Soulie M. Androgen-deprivation therapy alone or with docetaxel in non-castrate metastatic prostate cancer (GETUG-AFU 15): a randomised, open-label, phase 3 trial. Lancet Oncol. 2013 Feb;14(2):149-58. doi: 10.1016/S1470-2045(12)70560-0. Epub 2013 Jan 8. — View Citation

Hauber AB, Arellano J, Qian Y, Gonzalez JM, Posner JD, Mohamed AF, Gatta F, Tombal B, Body JJ. Patient preferences for treatments to delay bone metastases. Prostate. 2014 Nov;74(15):1488-97. doi: 10.1002/pros.22865. Epub 2014 Aug 17. — View Citation

Ryan M, Farrar S. Using conjoint analysis to elicit preferences for health care. BMJ. 2000 Jun 3;320(7248):1530-3. doi: 10.1136/bmj.320.7248.1530. No abstract available. — View Citation

Sartor O, de Bono JS. Metastatic Prostate Cancer. N Engl J Med. 2018 Feb 15;378(7):645-657. doi: 10.1056/NEJMra1701695. Epub 2018 Feb 7. No abstract available. — View Citation

Uemura H, Matsubara N, Kimura G, Yamaguchi A, Ledesma DA, DiBonaventura M, Mohamed AF, Basurto E, McKinnon I, Wang E, Concialdi K, Narimatsu A, Aitoku Y. Patient preferences for treatment of castration-resistant prostate cancer in Japan: a discrete-choice experiment. BMC Urol. 2016 Nov 4;16(1):63. doi: 10.1186/s12894-016-0182-2. Erratum In: BMC Urol. 2017 Mar 28;17 (1):20. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Patient preferences for treatment attributes in prostate cancer from different stages of disease Derived from discrete choice experiment 15 minutes (Once through survey)
Primary The Preference weighting from Physicians involved in the treatment of prostate cancer in term of risk/benefit attributes of treatment. Derived from discrete choice experiment. 15 minutes (Once through survey)
Secondary To examine the effect of socio-economic status on preference weighing Derived from discrete choice experiment 15 minutes (Once through survey)
Secondary To examine the status of comorbidities on preference weighing Derived from discrete choice experiment 15 minutes (Once through survey)
Secondary To examine their willingness of trading off survival with improving QOL Derived from discrete choice experiment 15 minutes (Once through survey
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