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Effect of low dose vs standard dose abiraterone on biochemical failure in metastatic prostate cancers

Protocol summary

Study aim
Assessment of the effect of low dose vs standard dose abiraterone on biochemical failure in metastatic prostate cancers
Design
Non-randomized, parallel group trial with non-blinded outcome assessment. Phase 2 trial in 64 patients.
Settings and conduct
High volume metastatic hormone sensitive prostate cancer patients who are candidates for triplet therapy were divided into two groups based on the physician opinion: 1- Hormone therapy + docetaxel + low dose abiraterone (250mg daily) up to one year later 2- Hormone therapy + docetaxel + standard dose abiraterone (1000mg daily) up to one year later
Participants/Inclusion and exclusion criteria
Metastatic prostate cancer patients who are candidates for triplet therapy were included in the study; patients who are resistant to hormone therapy were excluded.
Intervention groups
1- Hormone therapy + docetaxel + low dose abiraterone. 2- Hormone therapy + docetaxel + standard dose abiraterone
Main outcome variables
biochemical free survival

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120618010057N3
Registration date: 2022-04-30, 1401/02/10
Registration timing: registered_while_recruiting

Last update: 2022-04-30, 1401/02/10
Update count: 0
Registration date
2022-04-30, 1401/02/10
Registrant information
Name
Abolfazl Razzaghdoust
Name of organization / entity
shahid beheshti medical University
Country
Iran (Islamic Republic of)
Phone
+98 21 8882 5904
Email address
razzaghdoust@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-30, 1401/02/10
Expected recruitment end date
2023-04-29, 1402/02/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of low dose vs standard dose abiraterone on biochemical failure in metastatic prostate cancers
Public title
Comparison of low dose vs standard dose abiraterone in prostate cancer patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Metastatic prostate cancer patients who are candidates for triplet therapy
Exclusion criteria:
Hormone resistant
Age
No age limit
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Urology and Nephrology Research Center
Street address
No. 103, Shahid Jafari St., Pasdaran Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1666677951
Approval date
2022-03-06, 1400/12/15
Ethics committee reference number
IR.SBMU.UNRC.REC.1401.011

Health conditions studied

1

Description of health condition studied
Prostate cancer
ICD-10 code
C61
ICD-10 code description
Malignant neoplasm of prostate

Primary outcomes

1

Description
Biochemical free survival
Timepoint
3 months interval
Method of measurement
Prostate-Specific Antigen (PSA) test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Hormone therapy + docetaxel + low dose abiraterone. Androgen deprivation therapy (ADT)+ docetaxel + abiraterone 250mg daily + prednisolone daily until one year later. Abiraterone will be administered with low fat food. ADT as triptorelin 3.75mg will be administered monthly.
Category
Treatment - Drugs

2

Description
Control group: Hormone therapy + docetaxel + standard dose abiraterone. Androgen deprivation therapy (ADT) + docetaxel + abiraterone 1000mg daily + prednisolone daily until one year later. ADT as triptorelin 3.75mg will be administered monthly.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shohada-e-Tajrish hospital
Full name of responsible person
Bahram Mofid
Street address
No. 103, Shahid Jafari St., Pasdaran Ave., Tehran, Iran
City
tehran
Province
Tehran
Postal code
1666677951
Phone
+98 21 2256 7222
Email
mofid429@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Abbas Basiri
Street address
Velenjak St.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2256 7222
Email
basiri_a@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Abolfazl Razzaghdoust
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biology
Street address
No. 103, Shahid Jafari St., Pasdaran Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1666677951
Phone
+98 21 2256 7222
Email
razzaghdoust@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Abolfazl Razzaghdoust
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biology
Street address
No. 103, Shahid Jafari St., Pasdaran Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1666677951
Phone
+98 21 2256 7222
Email
razzaghdoust@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Abolfazl Razzaghdoust
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biology
Street address
No. 103, Shahid Jafari St., Pasdaran Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1666677951
Phone
+98 21 2256 7222
Email
razzaghdoust@sbmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Primary outcome data
When the data will become available and for how long
After publication of the results
To whom data/document is available
Academic organs
Under which criteria data/document could be used
No restriction
From where data/document is obtainable
Abolfazl Razzaghdoust razzaghdoust@sbmu.ac.ir
What processes are involved for a request to access data/document
A formal email to make a request
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