Tokyo, Jan. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000057234) titled 'A registry study of CHemotherApy-ineligible Metastatic hormone-sensitive Prostate cancer' on Jan. 1.
Study Type:
Observational
Primary Sponsor:
Institute - Department of Urology, Sapporo Medical University School of Medicine
Condition:
Condition - metastatic hormone-sensitive prostate cancer
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - To investigate the current state of treatment and prognosis for metastatic hormone-sensitive prostate cancer (mHSPC) that does not receive chemotherapy.
Basic objectives2 - Efficacy
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Male
Key inclusion criteria - 1) Those diagnosed with mHSPC
2) Those aged 20 years or older at the time of consent
3) Those who are able to take medication orally
4) Those receiving drug therapy for mHSPC that does not include chemotherapy
5) Those who have given written consent to participate in this study
Key exclusion criteria - 1) Those who have not had a histological diagnosis of prostate cancer
2) Those who have had a malignant tumour other than prostate cancer within the last 3 years
3) Those who have serious (requiring hospitalisation) and uncontrollable complications other than malignant tumours
4) Those who have a seizure disorder requiring anticonvulsant treatment (except those in a clinically stable period or those without seizures)
5) Those with severe liver dysfunction
6) Those with a history of hypersensitivity to the components of the mHSPC treatment drug
7) Those who are unable or unwilling to cooperate with the procedures of this study
8) Those who are deemed by the treating physician to be unsuitable subjects for this study.
Target Size - 250
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 02 Month 01 Day
Anticipated trial start date - 2025 Year 05 Month 01 Day
Last follow-up date - 2031 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065419
Disclaimer: Curated by HT Syndication.