RecruitingPhase 2NCT06818682

Reduced Length of ADT and ARTA With XRT in High-Risk Prostate Cancer (RELAX): A Randomised Trial


Sponsor

Tata Memorial Centre

Enrollment

206 participants

Start Date

Feb 17, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Aim of the study to improve the treatment of high-risk non-metastatic prostate cancer by comparing reduced duration of hormone therapy to the standard duration of two years, when combined with curative intent standard of care radiotherapy to prostate and pelvic nodes. The reduced duration will be intensified with addition of newer hormonal agents such as abiraterone or enzalutamide tablets, which have been shown to improve disease control in locally advanced prostate cancer. This is hoped to reduce the side effects of prolonged hormone therapy, while maintaining similar rates of disease control and survival. The effectiveness of both treatment approaches will be assessed in terms of cancer control, survival, and overall quality of life of patients. Additionally, the study will examine the side effects associated with each treatment regimen, which could provide valuable insights into impact of treatment duration on patients. If a person decides not to participate, they will still receive the standard two years of hormonal therapy and radiation therapy outside the study. This ensures that all patients receive appropriate care regardless of their involvement in the research. Participation is voluntary, and will not affect patient care.


Eligibility

Sex: MALEMin Age: 19 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This randomized trial (called RELAX) is comparing two lengths of hormone therapy alongside radiation therapy for high-risk prostate cancer. It aims to find out if a shorter course of hormone treatment works just as well as the current standard. **You may be eligible if...** - You have biopsy-proven prostate cancer suitable for curative radiation therapy - Your cancer is classified as high risk or very high risk (based on staging, Gleason score, or PSA level) - You are fit enough to receive hormone therapy for up to 2 years and a newer hormonal drug for 6 months - Your cancer has not spread to lymph nodes or distant sites (N0M0) **You may NOT be eligible if...** - Your cancer has a primary Gleason pattern of 5 (most aggressive grade) - Your life expectancy is less than 2 years - You have uncontrolled diabetes or high blood pressure that would make you ineligible for the hormonal drugs - Your tumor extensively invades the bladder, rectum, or nearby structures Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interventions

DRUGADT for 9 months and ARTA for 6 months

Radiotherapy to prostate and pelvic nodes (66-68Gy and 50Gy in 25 fractions OR 60-62Gy and 44Gy in 20 fractions OR 36.25-40Gy and 25Gy in 5 fractions) with ADT for 9 months and ARTA for 6 months

DRUGADT for 2 years

Radiotherapy to prostate and pelvic nodes (66-68Gy and 50Gy in 25 fractions OR 60-62Gy and 44Gy in 20 fractions OR 36.25-40Gy and 25Gy in 5 fractions) with ADT for 2 years


Locations(1)

Tata Memorial Centre

Mumbai, Maharashtra, India

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NCT06818682


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