Actively Recruiting
Reduced Length of ADT and ARTA With XRT in High-Risk Prostate Cancer (RELAX): A Randomised Trial
Led by Tata Memorial Centre · Updated on 2025-02-21
206
Participants Needed
1
Research Sites
515 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Reduced Length of ADT and ARTA With XRT in High-Risk Prostate Cancer (RELAX): A Randomised Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with biopsy-proven prostate adenocarcinoma suitable for curative radiotherapy
- Clinicoradiological stage T1-T4N0M0 confirmed by PSMA-PETCT and MRI
- High or very high risk prostate cancer as defined by NCCN 2023 (T3a+, Gleason Score 4+4 or 4+5, or PSA 20+)
- Patient fit to receive androgen deprivation therapy for 2 years
- Patient fit to receive androgen receptor-targeted agents for 6 months
- ECOG performance status of 0 to 2
- Patient able and willing to provide informed consent and reliable for follow-up
You will not qualify if you...
- Primary Gleason pattern 5 (Gleason score 5+4 or 5+5)
- Life expectancy less than 2 years
- Uncontrolled conditions like diabetes or hypertension making ARTA unsafe
- Bulky primary disease with extensive invasion into bladder, rectum, or pelvic muscle
- Prior androgen deprivation therapy for more than 3 months before screening or prior orchiectomy
- Prior prostatectomy
- Unsuitable for curative radiotherapy due to severe urinary symptoms, inflammatory bowel disease, prior pelvic radiotherapy, etc.
- Presence of adverse pathological variants such as small cell histology
- Unable or unwilling to provide consent and follow-up
AI-Screening
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Trial Site Locations
Total: 1 location
1
Tata Memorial Centre
Mumbai, Maharashtra, India, 400012
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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