A study to capture the side effects and Quality of life(QoL) in castration-resistant prostate cancer patients who are receiving docetaxel as part of standard therapy in Tata Memorial Centre.

Not yet recruiting

• Conditions: Malignant neoplasm of prostate,

• Registration Number: CTRI/2019/09/021080
• Lead Sponsor: Tata Memorial Centre

Brief Summary

Cancer is a dreaded disease and can compromise the life of the patient. They are treated with anti-cancer drug s which can cause many adverse drug reactions (ADRs) along with the beneficial effect, which can compromise their quality of life. As a standard treatment practice, castration-resistant prostate cancer patients are treated with Docetaxel as either 2 weekly or 3 weekly regimen depending on the clinical decision. We would like to conduct a study to systematically capture the adverse events experienced by the castration-resistant prostate cancer patients who are receiving docetaxel. We will be regularly following the patients as long as they are on treatment with docetaxel, which could be till the progression of disease, death or patient lost to follow up (which-ever is earlier). In addition to ADRs we will also be capturing the quality of life (QoL) data of patients who are taking docetaxel using validated EORTC QOL C-30 and EORTC QOL PR-25 Questionnaires. This QoL data will be obtained every 2 to 3 months (depending on the clinical condition of the patient) as long as the patient is on docetaxel which could be till the progression of the disease, death or patient lost to follow up (which-ever is earlier).

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2019-04-09
• Study Start: 2019-09-19

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Male
• Target Recruitment: 200

Inclusion Criteria

• Patient of either gender aged 18 or more than 18 2.
• Metastatic Prostate Carcinoma patients receiving docetaxel chemotherapy.

Exclusion Criteria

• Patient not willing to give consent.
• Patients having non-compliance to the treatment schedule at Tata memorial Hospital or ACTREC.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse Drug Reaction	2 Weekly- 3 Weekly

Secondary Outcome Measures

Name	Time	Method
quality of life	2-3 Monthly
Grade III and Grade IV adverse events	2 Weekly- 3 Weekly
Causality assessment of the adverse reactions	2 Weekly- 3 Weekly

Trial Locations

Locations (2)

ACTREC; 🇮🇳 Mumbai, MAHARASHTRA, India

Tata Memorial Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

ACTREC

🇮🇳Mumbai, MAHARASHTRA, India

Dr Amit Joshi

Principal investigator

02227405000

dramitjoshi74@gmail.com