Assessing demographic, clinical and pathological determinants of advances prostate cancer in Indonesia for delayed diagnosis, treatment, and risk for secondary progression and survival

ISRCTN	ISRCTN24834343
DOI	https://doi.org/10.1186/ISRCTN24834343

Submission date: 14/10/2020
Registration date: 18/10/2020
Last edited: 16/10/2020

Recruitment status: No longer recruiting
Overall study status: Ongoing
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Andy Zulfiqqar
Public

JemurSari Regency Blok E.1
Surabaya
60237
Indonesia

ORCID ID	0000-0001-5191-5428
Phone	+62 85239555553
Email	zulfiqqar.andy@mail.ugm.ac.id

Dr Indrawarman Soehardjo
Public

Jl. Kesehatan No.1
Sleman
84311
Indonesia

ORCID ID	0000-0002-1224-0568
Phone	+62 (0) 274560300
Email	indrawarman@mail.ugm.ac.id

Study information

Study design	Observational cohort retrospective study
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	No participant information sheet available
Scientific title	Surrogate biomarkers for Castration-resistant Prostate Cancer (CRPC): Indonesian population
Study acronym	INA-BIOPRO
Study objectives	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(s)	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
Health condition(s) or problem(s) studied	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
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 study start date	01/01/2017
Completion date	01/01/2027

Eligibility

Participant type(s)	Patient
Age group	Senior
Lower age limit	18 Years
Upper age limit	80 Years
Sex	Male
Target number of participants	300
Key inclusion criteria	1. Diagnosed with advanced prostate cancer 2. Aged 18 - 80 years
Key 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
Date of first enrolment	10/04/2020
Date of final enrolment	01/06/2025

Locations

Countries of recruitment

Indonesia

Study participating centre

RSUP Dr Sardjito Hospital

Jl. Kesehatan No.1
Senolowo
Sinduadi
Kec. Mlati
Kabupaten Sleman
Daerah Istimewa
Yogyakarta
Sleman
55281
Indonesia

Sponsor information

Fakultas Kedokteran, Kesehatan Masyarakat dan Keperawatan UGM
University/education

Farmako Sekip
Utara Street
Yogyakarta
Sleman
84311
Indonesia

Phone	+62 274 560 300, ext 205
Email	orp.fm@ugm.ac.id
Website	https://fk.ugm.ac.id/en/

Funders

Funder type

University/education

Fakultas Kedokteran, Kesehatan Masyarakat dan Keperawatan UGM

No information available

Results and Publications

Intention to publish date	30/06/2027
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
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 plan	The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.

Editorial Notes

15/10/2020: Trial’s existence confirmed by Ethics Committee of the Faculty of Medicine, Public Health, and Nursing - Universitas Gadjah Mada Yogyakarta