Clinical Trials List
2014-10-01 - 2024-12-30
Phase II
Recruiting6
Study ended15
ICD-10D40.0
Neoplasm of uncertain behavior of prostate
ICD-9236.5
Neoplasm of uncertain behavior of prostate
A PHASE II, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF MCS® IN PROSTATE CANCER PREVENTION
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Trial Applicant
Health Ever Bio-Tech Co.,Ltd
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Sponsor
Health Ever Bio-Tech Co., Ltd.
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Trial scale
Taiwan Multiple Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Study ended
Co-Principal Investigator
- 林登龍 Division of Urology
The Actual Total Number of Participants Enrolled
0 Study ended
Co-Principal Investigator
- 吳俊德 Division of Urology
The Actual Total Number of Participants Enrolled
0 Study ended
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Study ended
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Study ended
The Actual Total Number of Participants Enrolled
0 Study ended
The Actual Total Number of Participants Enrolled
0 Study ended
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Study ended
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Study ended
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Study ended
The Actual Total Number of Participants Enrolled
0 Study ended
Co-Principal Investigator
- 吳東霖 Division of Urology
The Actual Total Number of Participants Enrolled
0 Study ended
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Study ended
The Actual Total Number of Participants Enrolled
0 Study ended
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Study ended
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Cumulative biopsy-detectable prostate cancer rate at Week 104 (Month 24).
2. Secondary endpoints:
Gleason’s grade and sum at diagnosis of prostate cancer.
Percentage of positive cores involved at diagnosis.
Percentage of cancer positive area involved.
Prostate volume.
Changes in International Prostate Symptom Score (I-PSS) sub-score, total score
and the Quality of Life (QOL) score.
Changes in the 5-Item Version of the International Index of Erectile Function
(IIEF-5) total score (erectile function).
Inclution Criteria
(1) Four groups of high-risk subjects as defined below. Except for the first
group of subjects, previous prostate systematic biopsies prior to
screening should be of 10 or more cores. It is advised that at least 12-core
biopsy be done for subjects with a prostate size of 40 ml or larger. The last
prostate biopsy should have been taken within 18 months prior to screening.
If the last biopsy was not performed within 18 months prior to screening, the
biopsy result will not be accepted and the biopsy will not be count into the
total number of biopsy that subject have taken.
(2) Male subject with age from 50 to 75 years old.
(3) No active urinary tract infection (UTI) or bacterial prostatitis. Subjects with
chronic non-bacterial prostatitis are allowed to participate. Urine bacterial
culture after prostate message should be negative if chronic prostatitis is or
has been impressed. Subjects with abnormal urinary white blood cell (WBC)
counts are still eligible provided that a negative urine bacterial culture
including TB culture is documented.
(4) Subject is able to understand and willing to comply with the study procedures
and has signed the informed consent form (ICF).
Exclusion Criteria
(1) Subjects’ elevated PSA is deemed by the investigators solely to inflammation
or infection of the prostate.
(2) Subjects who are or will be taking long-term hormonal agents that may affect
the normal physiology of sex hormone function. Subjects should discontinue
hormonal agents for 16 weeks or longer prior to screening. These hormonal
agents include, but are not limited to, 5-α reductase inhibitors, androgen,
anti-androgens, estrogens, anti-estrogens, progesterone or derivatives,
aromatase inhibitors, luteinizing hormone-releasing hormone (LHRH)
agonists or antagonists; and adrenal suppressing agents such as
spironolactone and ketoconazole.
(3) Subjects with a PSA > 10.0 ng/ml. If the PSA value is 10.0 ng/ml prior to
screening but is > 10.0 ng/ml during the screening period, a second PSA test
prior to randomization is needed to determine the eligibility. If the second
PSA is within the required ranges, the subject is eligible for enrolment. If the
second PSA is still > 10.0 ng/ml, the subject is not eligible for the study.
(4) Subjects with a history of prostate cancer.
(5) Subjects are currently taking or planning to take oral bile acid sequestrants.
(6) Subjects have celiac disease, Crohn’s disease, partly removal of the intestinal
tract (surgically), or any malabsorption conditions.
(7) Subject participated in another investigational agent study in the past 30 days
or is planning to do so during the study period.
(8) Subjects are considered ineligible for the study as judged by the investigator.
(9) Other malignancies except non-melanoma skin cancer. However, subjects with
other cancers that have been disease-free for 5 or more years and deemed no
need for anti-cancer treatments can be recruited.
The Estimated Number of Participants
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Taiwan
702 participants
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Global
702 participants
