Liquid biopsy for prostate lesions

• Register: CTRI
• Last refreshed on: 29 May 2023
• Main ID: CTRI/2019/02/017863
• Date of registration: 28-02-2019
• Prospective Registration: Yes
• Primary sponsor: Datar Cancer Genetics Limited
• Public title: Liquid biopsy for prostate lesions
• Scientific title: Utility of ProStateTM, the liquid biopsy platform in distinguishing Prostate malignancies from Benign Prostatic Hyperplasia.
• Date of first enrolment: 01-03-2019
• Target sample size: 300
• Recruitment status: Closed to Recruitment of Participants
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=31713
• Study type: Observational
• Study design: Other Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label
• Phase: N/A

Countries of recruitment

India

Contacts

• Name: Dr Dadasaheb Akolkar
• Affiliation: Datar Cancer Genetics Limited

• Name: Dr Dadasaheb Akolkar
• Affiliation: Datar Cancer Genetics Limited

Key inclusion & exclusion criteria

Inclusion criteria: i.Patients with enlarged prostate or elevated PSA or suspicious DRE finding who are therapy naïve.

ii.Age >= 50 years.

iii.Provision of signed and dated informed consent form.

iv.Stated willingness to comply with all study procedures.


Exclusion criteria: Patients who fail to meet all of the above criteria for cases will be excluded. Failing to meet any single criteria would be sufficient grounds for exclusion.

i.Age <50 years.

ii.Active or latent hepatitis B or active hepatitis C or any uncontrolled infection at screening, including (but not limited to) HIV, HPV or tuberculosis.

iii.Patient has an investigational medicinal product within the last 30 days of blood collection.

iv.Personal history of any cancer in the past.

v.Blood transfusion in past 1 month.

vi.(PET-)CT scan in past 14 days.

vii.Patients must have discontinued steroids >= 1 week prior to screening,

NOTE: The following steroids are permitted (low dose steroid use is defined as prednisone 10 mg daily or less, or bioequivalent dose of other corticosteroid):

a.Temporary steroid use for CT imaging in setting of contrast allergy,

b.Low dose steroid use for appetite,

c.Chronic inhaled steroid use,

d.Steroid injections for joint disease,

e.Stable dose of replacement steroid for adrenal insufficiency or low doses for non-malignant disease,

f.Topical steroids.



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: C00-D49- Neoplasms

Primary Outcome(s)

To evaluate utility of ProStateTM in distinguishing prostate malignancies from Benign Prostatic Hyperplasia.

Outcome Measure: Positive predictive value of ProStateTM to differentiate prostate malignancies from Benign Prostatic Hyperplasia.

Timepoint: Evaluation Timepoint: Day 0 (Blood sampling at the time of recruitment)

Secondary Outcome(s)

To determine the grade (Gleason Score) of confirmed Ca Prostate.

Outcome Measure: Comparison of Gleason Score with molecular profiling of blood sample.

Timepoint: Evaluation Timepoint: Day 0 (Blood sampling at the time of recruitment)

Secondary ID(s)

NIL

Source(s) of Monetary Support

Datar Cancer Genetics Limited, F-8, D Road, MIDC, Ambad, Nasik, Maharashtra 422 010

Canconnect Foundation, Flat No.12, Ameya Sankul, B Wing, Sharanpur Road, Nasik, Maharashtra 422 005

Secondary Sponsor(s)

Canconnect Foundation

Ethics review

Status: Approved
Approval date: 31/12/2018
Contact:

Datar Cancer Genetics Limited Ethics Committee