Last updated: October 12, 2023
Sponsor: Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
Overall Status: Active - Not Recruiting
Phase
2/3
Condition
Covid-19
Prostate Cancer
Prostate Cancer, Early, Recurrent
Treatment
Abiraterone - Usual
Abiraterone - Study
Clinical Study ID
NCT03348670
IND 168800 to be IND EXEMPT
IND167005
IND 168800
IND166012
NPI - 1831468511
IRB00009424
FWA00015357
NPI - 1023387701
IORG0007849
Ages 22-75 Male
Study Summary
Eligibility Criteria
Inclusion
- Select 600 localized Prostate Cancer Patients without prostate resection
- Dosage Duration at least 90 days
- The usual approach group - Recruit 300 double blind random group separated prostatecancer patients currently used the Combined Chemotherapy High Dose on ZYTIGA -abiraterone acetate tablet, film coated plus RAYOS - prednisone tablet, delayedrelease plus ORGOVYX - relugolix tablet, film coated, like as the usual approachgroup.
- The study approach group - Recruit 300 double blind random group separated prostatecancer patients currently used the Combined Chemotherapy Low Dose on ZYTIGA -abiraterone acetate tablet plus RAYOS - prednisone tablet, delayed release plusORGOVYX - relugolix tablet, film coated, like as the study approach group. Inclusion Criteria:
- Clinical diagnosis of Prostate Cancer (PC)
- Cancer in the prostate only
- Prior therapy without orchiectomy
- Prior therapy without prostate resection
- Prior different chemotherapy must-need stop
- Have no other cancer at the same time
- Sign an informed consent form
- Receive blood-drawing
Exclusion
Exclusion Criteria:
- Treatment with other anti-cancer therapies and the therapies cannot be stoppedcurrently
- The patients with other serious intercurrent illness or infectious diseases
- Have more than one different kind of cancer at the same time
- Serious Allergy to Drugs
- Serious Bleed Tendency
- Serious Risks or Serious Adverse Events of the drug product label
- Serious Risks or Serious Adverse Events of NCI Table of Side Effects
- The prohibition of drug products
- Have no therapeutic effects
- Follow up to the most current label and plan for safety monitoring
Study Design
Total Participants: 600
Treatment Group(s): 2
Primary Treatment: Abiraterone - Usual
Phase: 2/3
Study Start date:
August 18, 2023
Estimated Completion Date:
May 28, 2024
Study Description
Connect with a study center
Medicine Invention Design, Inc. (MIDI) - c/o - MIDINC Clinical Investigator Working Site
Gaithersburg, Maryland 20877
United StatesSite Not Available
Medicine Invention Design, Inc. (MIDI) - c/o - MIDINC Clinical Investigator Working Site
North Bethesda, Maryland 20852
United StatesSite Not Available
MIDI Clinical Trial Sites -c/o- Dr. Han Xu - Sponsor / Investigators / Physicians / Laboratories Operation Site
Rockville, Maryland 20853
United StatesSite Not Available
Medicine Invention Design, Inc. - IORG0007849 - NPI-1023387701
Rockville, Maryland 20853
United StatesSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.