Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
434

Summary

Conditions
Prostate Adenocarcinoma
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Only males

Description

The standard duration of treatment with radiotherapy is 8 weeks in conventional fractionation; 5-6 weeks with moderate hypo-fractionation, while it is only 1- 2 weeks with extreme hypo-fractionation (SBRT).The health costs and out of pocket expenditure involved in the conventional hypo-fractionated ...

The standard duration of treatment with radiotherapy is 8 weeks in conventional fractionation; 5-6 weeks with moderate hypo-fractionation, while it is only 1- 2 weeks with extreme hypo-fractionation (SBRT).The health costs and out of pocket expenditure involved in the conventional hypo-fractionated radiotherapy treatment largely depends on the overall treatment duration. This involves expenditure not only for the patient but also the caretaker. Moreover most of these patients presenting to a tertiary care centre from different parts of the country, have logistic issues of accommodation, food, travel along with the treatment costs. Also for patients staying away from family, 5 weeks treatment without considerable family support has a psychological impact, especially on elderly group of patients commonly seen with prostate cancer.This further leads to a major cause of distress among these patients, especially in a resource limited setting as ours. Extreme hypo-fractionation with a total duration of 2 weeks, would offer an opportunity to optimize the therapeutic ratio taking advantage of the potential therapeutic gain due to low alpha/beta for prostate to higher dose/fraction(compared to surrounding organs at risk). Moreover, shortened overall treatment time,would lead to less distressing and early recommencement of their daily activities for the patients,with an obvious impact in improving the quality of life and health costs. Given the potential positive economic impact with shorter duration treatment with similar clinical outcomes and probable similar toxicity profile, SBRT (extreme hypo-fractionation) in prostate cancer is an attractive treatment option, especially in a limited-resource setting and can have a large and positive impact on the patient care.

Tracking Information

NCT #
NCT03561961
Collaborators
Tata Medical Center
Investigators
Principal Investigator: Vedang Murthy Tata Memorial Centre