Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 11:21 PM
Study NCT ID:
NCT05761093
Status:
RECRUITING
Last Update Posted:
2025-05-06
First Post:
2023-02-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Patient and Physician Benefit/ Risk Preferences for Treatment of mPC in Hong Kong: a Discrete Choice Experiment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 306}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-04', 'studyFirstSubmitDate': '2023-02-28', 'studyFirstSubmitQcDate': '2023-02-28', 'lastUpdatePostDateStruct': {'date': '2025-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient preferences for treatment attributes in prostate cancer from different stages of disease', 'timeFrame': '15 minutes (Once through survey)', 'description': 'Derived from discrete choice experiment'}, {'measure': 'The Preference weighting from Physicians involved in the treatment of prostate cancer in term of risk/benefit attributes of treatment.', 'timeFrame': '15 minutes (Once through survey)', 'description': 'Derived from discrete choice experiment.'}], 'secondaryOutcomes': [{'measure': 'To examine the effect of socio-economic status on preference weighing', 'timeFrame': '15 minutes (Once through survey)', 'description': 'Derived from discrete choice experiment'}, {'measure': 'To examine the status of comorbidities on preference weighing', 'timeFrame': '15 minutes (Once through survey)', 'description': 'Derived from discrete choice experiment'}, {'measure': 'To examine their willingness of trading off survival with improving QOL', 'timeFrame': '15 minutes (Once through survey', 'description': 'Derived from discrete choice experiment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '29412780', 'type': 'BACKGROUND', '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.'}, {'pmid': '15117387', 'type': 'BACKGROUND', '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.'}, {'pmid': '23355792', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '27814714', 'type': 'BACKGROUND', '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.'}, {'pmid': '25132622', 'type': 'BACKGROUND', '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.'}, {'pmid': '10834905', 'type': 'BACKGROUND', '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.'}, {'pmid': '30763142', 'type': 'BACKGROUND', '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.'}, {'pmid': '23306100', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '300 consecutive patients with metastatic prostate cancer (150 mHSPC and 150 mCRPC) within 5 years will be recruited', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged 18 years or older,\n* diagnosis of metastatic prostate cancer within 5 years,\n* able to read and write,\n* accepting and signing the informed consent\n\nExclusion Criteria:\n\n* if patients are unable to complete the survey by themselves due to physical or psychological reasons,\n* deemed ineligible by treating physicians if patients are unable to complete the survey by themselves due to physical or psychological reasons,\n* deemed ineligible by treating physicians'}, 'identificationModule': {'nctId': 'NCT05761093', 'briefTitle': 'Patient and Physician Benefit/ Risk Preferences for Treatment of mPC in Hong Kong: a Discrete Choice Experiment', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'A Study to Evaluate Patient and Physician Benefit/ Risk Preferences for Treatment of Metastatic Prostate Cancer (mPC) in Hong Kong: a Discrete Choice Experiment', 'orgStudyIdInfo': {'id': 'CRE-2022.301'}}, 'contactsLocationsModule': {'locations': [{'city': 'Shatin', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Chi Fai NG, MD', 'role': 'CONTACT', 'email': 'ngcf@surgery.cuhk.edu.hk', 'phone': '3505 2625'}], 'facility': 'Prince of Wales Hospital', 'geoPoint': {'lat': 22.38333, 'lon': 114.18333}}], 'centralContacts': [{'name': 'Chi Fai NG, MD', 'role': 'CONTACT', 'email': 'ngcf@surgery.cuhk.edu.hk', 'phone': '35052625'}], 'overallOfficials': [{'name': 'Chi Fai NG, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese University of Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'NG Chi Fai', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}