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Study to determine the local prevalence in Indian patients in Prostate cancer

A non-interventional, multicenter study to determine the prevalence of homologous recombination repair (HRR) gene mutations in patients with metastatic castration-resistant prostate cancer in India - PROSPECT

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/12/038578
Enrollment
206
Registered
2021-12-10
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C61- Malignant neoplasm of prostate

Interventions

None listed

Sponsors

AstraZeneca Pharma India Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Male participants aged =18 = 80 years of age. 2. Pathological mCRPC cases confirmed by laboratory (PSA and testosterone levels), X-rays (optional),(CT scan/ MRI scan / PET scan) . 3. Availability of medical history (demographic information and history of cancer) 4. Participants who are able to provide written informed consent form (ICF).

Exclusion criteria

Exclusion criteria: 1. Diagnosis of any severe acute or chronic medical or psychiatric conditions that may increase the risk associated with study participation or may interfere with the interpretation of the study results. 2. Newly diagnosed mCRPC participants without tissue sample availability.

Design outcomes

Primary

MeasureTime frame
Prevalence of HRR mutations identified in mCRPC participants in India.Timepoint: one time—

Secondary

MeasureTime frame
1. Demographic and clinical characteristics of mCRPC participants with HRR mutations in India. 2. Describe the prevalence of each of the 15 HRR gene mutations in participants with mCRPCTimepoint: one time—

Countries

India

Contacts

Public ContactMr Amit Kumar

AstraZeneca Pharma India Ltd

subhankar.basak@astrazeneca.com919833079692

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026