Plain English Summary
Background and study aims
The prostate is a small gland in the pelvis, found only in men. The causes of prostate cancer are largely unknown.
Several treatment options for patients range from active surveillance for less aggressive cancer to surgery and radiation for more advanced diseases. Androgen deprivation therapy (ADT) is an anti-hormone therapy for treating prostate cancer. But recently, tumors were identified that generally grow independent to the androgen hormone levels. This study aims to identify measures that can predict the outcome of ADT in Indonesian men.
Who can participate?
Patients aged 18 - 80 years old with a diagnosis of prostate cancer from 2017 to 2027
What does the study involve?
The study involves collecting information from patient records on the risk factors, course of the disease, the response to different treatments, recurrence rates, progression into other cancers, and death rates. There is an optional choice to provide a number of blood or tissue samples for the duration of diagnosis, treatment, and follow-up.
What are the possible benefits and risks of participating?
There are no specific risks or benefits to participants.
Where is the study run from?
Universitas Gadjah Mada / Dr Sardjito Hospital, Yogyakarta (Indonesia)
When is the study starting and how long is it expected to run for?
January 2017 to January 2027
Who is funding the study?
Universitas Gadjah Mada (Indonesia)
Who is the main contact?
1. Dr Andy Zulfiqqar
zulfiqqar.andy@mail.ugm.ac.id
2. Dr Indrawarman Sp.U
indrawarman@mail.ugm.ac.id
Trial website
Contact information
Type
Public
Primary contact
Dr Andy Zulfiqqar
ORCID ID
https://orcid.org/0000-0001-5191-5428
Contact details
JemurSari Regency Blok E.1
Surabaya
60237
Indonesia
+62 85239555553
zulfiqqar.andy@mail.ugm.ac.id
Type
Public
Additional contact
Dr Indrawarman Soehardjo
ORCID ID
https://orcid.org/0000-0002-1224-0568
Contact details
Jl. Kesehatan No.1
Sleman
84311
Indonesia
+62 (0) 274560300
indrawarman@mail.ugm.ac.id
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
Nil known
Study information
Scientific title
Surrogate biomarkers for Castration-resistant Prostate Cancer (CRPC): Indonesian population
Acronym
INA-BIOPRO
Study hypothesis
Surrogate Biomarker, Demographic, social, clinical, and pathological determinants are associated with delayed diagnosis, risks of relapse, and survival of Prostate Cancer diagnosed and treated according to the local and national guidelines in Indonesia. we downregulation TP53, RB1, PTEN and others associated RNA and MIR suggested predict the outcome of therapy.
Ethics approval
Approved 03/04/2020, Ethics Committee of the Faculty of Medicine, Public Health, and Nursing - Universitas Gadjah Mada Yogyakarta (Jl. Farmako Sekip Utara, Yogyakarta 55281, Surabaya,
84311, Indonesia; +62 274 588688 ext 17225; mhrec_fmugm@ugm.ac.id), ref: KE/0158/02/2020
Study design
Observational cohort retrospective study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
No participant information sheet available
Condition
Biomarker predicting the outcome of Androgen Deprivation Therapies and Chemotherapies in Prostate Cancer patients
Intervention
All patients who underwent prostate biopsy were enrolled in this study.
The biopsied prostate cancer will be tested for several biomarkers. mRNA expression of targeted biomarkers are conducted using Real Time-Polymerase Chain Reaction (qRT-PCR) in Anatomical Pathology Laboratory of the Faculty of Medicine, Universitas Gadjah Mada, Yogyakarta. RNA purification from prostate tissue are conducted using RibospinTM II (GeneAll®) kit and NEXproTM 1-step qRT-PCR 2x Master Mix (SYBR) were used in this study. All of the procedures followed the manufacturer’s recommendations.
Clinical data are collected from medical records to evaluate the clinical features and confirmation of diagnosis.
The targeted gene is quantified using reverse transcription-polymerase chain reaction. For the relative quantification, the target gene expression is determined by the (2−∆∆Ct) method after normalization to the gene of GAPDH for CT values. RNA Isolation and cDNA Synthesis.
Patient outcome is evaluated each month on outpatients setting or inpatient setting.
Intervention type
Not Specified
Phase
Drug names
Primary outcome measure
1. Time to achieve Castration resistant therapy (CRPC). CRPC is defined as castrate level of serum testosterone <50 ng/mL plus either
(i) biochemical progression – three consecutive rises of PSA, resulting in two 50% increases above the nadir value, with PSA >2 ng/mL, or
(ii) radiological progression – the appearance of two or more bone lesions on bone scan or enlargement of a soft tissue lesion based on RECIST criteria
Secondary outcome measures
1. Progression-free survival (PFS) measured using the methods described in the primary outcome measure at the end of the study
Overall trial start date
01/01/2017
Overall trial end date
01/01/2027
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Diagnosed with advanced prostate cancer
2. Aged 18 - 80 years
Participant type
Patient
Age group
Senior
Gender
Male
Target number of participants
300
Participant exclusion criteria
1. Received systemic chemotherapy, targeted therapy, and immunomodulatory therapy prior study
2. Received local therapy including radical prostatectomy, radiotherapy, and other local therapy
Recruitment start date
10/04/2020
Recruitment end date
01/06/2025
Locations
Countries of recruitment
Indonesia
Trial participating centre
RSUP Dr Sardjito Hospital
Jl. Kesehatan No.1
Senolowo
Sinduadi
Kec. Mlati
Kabupaten Sleman
Daerah Istimewa
Yogyakarta
Sleman
55281
Indonesia
Sponsor information
Organisation
Fakultas Kedokteran, Kesehatan Masyarakat dan Keperawatan UGM
Sponsor details
Farmako Sekip
Utara Street
Yogyakarta
Sleman
84311
Indonesia
+62 274 560 300, ext 205
orp.fm@ugm.ac.id
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Fakultas Kedokteran, Kesehatan Masyarakat dan Keperawatan UGM
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed international journal. Raw data without any identification of participants will be shared according to the WHO and ICMJE.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.
Intention to publish date
30/06/2027
Participant level data
Available on request
Basic results (scientific)
Publication list