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

Phase 2

Recruiting

• Conditions: Prostate Carcinoma
• Interventions: Drug: ADT for 9 months and ARTA for 6 months; Drug: ADT for 2 years

• Registration Number: NCT06818682
• Lead Sponsor: Tata Memorial Centre

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-07
• Study First Submitted QC: 2025-02-07
• Study First Posted: 2025-02-10
• Study Start: 2025-02-17
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-21
• Primary Completion: 2035-01-01
• Study Completion: 2035-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 206

Inclusion Criteria

• Patients with biopsy proven prostate adenocarcinoma, deemed suitable for curative- intent radiotherapy
• Clinicoradiological stage T1-T4N0M0 using PSMA-PETCT and MRI
• High risk or very high risk (as per NCCN 2023): stage T3a + OR Gleason Score 4+4 or 4+5 OR PSA 20 +
• Patient fit and able to receive ADT for 2 years
• Patient fit and able to receive ARTA for 6 months
• ECOG performance status 0-2
• Patient able and willing for informed consent and reliable for follow-up

Exclusion Criteria

• Primary Gleason pattern 5 (Gleason score 5+4 or 5+5)
• Life expectancy deemed to be less than 2 years
• Uncontrolled comorbidities such as diabetes or hypertension causing ineligibility to receive ARTA
• Bulky primary disease with extensive infiltration into bladder/rectum/pelvic muscle
• Prior ADT more than 3 months before screening or prior orchiectomy
• Prior prostatectomy
• Unsuitable for curative dose of radiotherapy (severe urinary obstructive symptoms, inflammatory bowel disease, prior pelvic radiotherapy etc.)
• Presence of adverse pathological variants (such as small cell histology)
• Unable or unwilling to consent and follow up

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test Arm	ADT 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
Standard Arm	ADT 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

Primary Outcome Measures

Name	Time	Method
Disease-free survival (DFS), defined as the time to first clinicoradiological recurrence or death due to any cause, from the date of randomisation.	5 years

Secondary Outcome Measures

Name	Time	Method
Biochemical failure free survival (BFFS)	5-year	Time to biochemical failure (nadir PSA + 2ng/mL) or death due to any cause

Trial Locations

Locations (1)

Tata Memorial Centre; 🇮🇳 Mumbai, Maharashtra, India