The study of compairing benefit of Abiraterone low versus full dose with Docetaxel in Prostate Cancer

DAHLIA: Docetaxel with Abiraterone full versus low dose in Hormone Sensitive Advanced Prostate Cancer – Phase III, Non-Inferiority Randomized Control Open Label Trial. - DAHLIA

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/03/050180

Enrollment

196

Registered

2023-03-01

Start date

Unknown

Completion date

Unknown

Last updated

2024-12-09

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

Intervention1: 6 cycles of Docetaxel with Abiraterone 1000mg fasting. : Patient will receive Androgen deprivation therapy (ADT) + Docetaxel chemotherapy with Abiraterone 1000mg in fasting state, follo

Eligibility

Inclusion criteria

Inclusion criteria: participants must be hormone sensitive prostrate cancer. Age above 18 years ECOG permance status participants must have normal organ and marrow function

Exclusion criteria

Exclusion criteria: 1.participants who are receiving any other investigational agents. 2.participants who are designated as unfit for receiving Abiraterone

Design outcomes

Primary

Measure	Time frame
To compare the non inferiority of low dose abiraterone 250mg with low fat meal compared to hogh dose abiraterone 1000mg with in fasting state to improve 3 year PSA PFS in patients with hormone sensitive metastatic prostate cancer receiving Androgen deprivation therapy+docetaxel chemotherapyTimepoint: 3 year	—

Secondary

Measure	Time frame
1. OS 2.Toxicity 3.QOLTimepoint: 3 years	—

Countries

India

Contacts

Public ContactMr Bhavesh P Bandekar

Mahamana Pandit Madan Mohan Malaviya Cancer Centre (MPMMCC)

bhavesh.bandekar1988@gmail.com08779187963

Outcome results

None listed

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