To study whether maintenance treatment with Abiraterone after docetaxel chemotherapy leads to further improvement in metastatic hormone sensitive prostate cancer.

Sequential Abiraterone following Docetaxel Chemotherapy in Hormone Sensitive Metastatic Prostate Cancer - SAD HORSE

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/02/023447

Enrollment

800

Registered

2020-02-19

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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 Health Condition 2: N508- Other specified disorders of malegenital organs

Interventions

Intervention1: Abiraterone: Arm B : Hormone therapy + Docetaxel chemotherapy followed by sequential Abiraterone. Control Intervention1: Observation: Arm A : Hormone therapy + Docetaxel chemotherapy f

Eligibility

Inclusion criteria

Inclusion criteria: 1. Participants must be hormone sensitive prostate cancer for a histologically confirmed adenocarcinoma of prostate. 2. ECOG performance status 3. 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 based chemotherapy.

Design outcomes

Primary

Measure	Time frame
For Phase II: PSA PFS: The interval between randomization and the date of documented progression or death before documented progression or treatment stopped due to any reason. Patients who have not progressed or died at their last follow ups would be censored. For Phase III: OS : OS will be defined as time period between date of randomization to date of death due to any cause. Patients alive at their last follow ups would be censored.Timepoint: 5 years	—

Measure

Time frame

For Phase II: PSA PFS: The interval between randomization and the date of documented progression or death before documented progression or treatment stopped due to any reason. Patients who have not progressed or died at their last follow ups would be censored. For Phase III: OS : OS will be defined as time period between date of randomization to date of death due to any cause. Patients alive at their last follow ups would be censored.Timepoint: 5 years

—

Secondary

Measure	Time frame
Toxicity: To compare CTCAE version 4.03 worst grade toxicity between the 2 arms during any period of chemotherapy. Overall Quality of Life: The Functional Assessment of Cancer Therapy-Prostate (FACIT-P) is a self report measure of both general and disease specific quality of life. Timepoint: 5 years	—

Countries

India

Contacts

Public ContactDr Amit Joshi

Tata Memorial Hospital

dramitjoshi74@gmail.com022-24176755

Outcome results

None listed

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