Condition category
Cancer
Date applied
14/10/2020
Date assigned
18/10/2020
Last edited
16/10/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

https://fk.ugm.ac.id/en/

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

Publication citations

Additional files

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