Tokyo, March 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060607) titled 'A registry study of chemotherapy-ineligible metastatic hormone-sensitive prostate cancer' on March 1.
Study Type:
Observational
Primary Sponsor:
Institute - 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 current treatment practices and prognoses for hormone-sensitive prostate cancer with metastases that does not undergo chemotherapy.
Basic objectives2 - Safety,Efficacy
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Male
Key inclusion criteria - 1) Patients diagnosed with metastatic hormone-sensitive prostate cancer (mHSPC).
2)Patients must be 20 years of age or older at the time of consent.
3)Patients capable of oral intake.
4)Patients receiving drug therapy for mHSPC that does not include chemotherapy.
5)Cases for which written consent has been obtained from the patient to participate in this study.
Key exclusion criteria - 1) Individuals without a histological diagnosis of prostate cancer.
2) Individuals with a history of malignant tumors other than prostate cancer within the past three years.
3) Individuals with severe, hospitalization-requiring, uncontrolled complications other than malignant tumors.
4) Individuals with convulsive disorders requiring anticonvulsant therapy, except those who are clinically stable or seizure-free.
5) Patients with severe hepatic impairment
Patients with a history of hypersensitivity to any component of mHSPC therapy drugs.
Patients lacking the ability or willingness to cooperate with the procedures of this study.
8) Patients deemed unsuitable for this study by the investigator.
Example: Patients participating in another clinical study (interventional study).
Target Size - 250
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2025 Year 05 Month 01 Day
Date of IRB - 2025 Year 05 Month 15 Day
Anticipated trial start date - 2025 Year 05 Month 16 Day
Last follow-up date - 2030 Year 02 Month 28 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069325
Disclaimer: Curated by HT Syndication.