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
2. Dr Indrawarman Sp.U
Dr Andy Zulfiqqar
JemurSari Regency Blok E.1
Dr Indrawarman Soehardjo
Jl. Kesehatan No.1
+62 (0) 274560300
Surrogate biomarkers for Castration-resistant Prostate Cancer (CRPC): Indonesian population
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.
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; firstname.lastname@example.org), ref: KE/0158/02/2020
Observational cohort retrospective study
Primary study design
Secondary study design
Patient information sheet
No participant information sheet available
Biomarker predicting the outcome of Androgen Deprivation Therapies and Chemotherapies in Prostate Cancer patients
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.
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
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
1. Diagnosed with advanced prostate cancer
2. Aged 18 - 80 years
Target number of participants
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
Recruitment end date
Countries of recruitment
Trial participating centre
RSUP Dr Sardjito Hospital
Jl. Kesehatan No.1 Senolowo Sinduadi Kec. Mlati Kabupaten Sleman Daerah Istimewa Yogyakarta
Fakultas Kedokteran, Kesehatan Masyarakat dan Keperawatan UGM
Funding Body Type
Funding Body Subtype
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
Participant level data
Available on request
Basic results (scientific)