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

NCT06818682 | Recruiting Phase 2 DMC

• 1 other identifier: 901060
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Carcinoma

Keywords

Prostate Cancer; Prostate Radiotherapy; Hormone therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Biochemical failure free survival (BFFS)

  5-year

Study Arms (2)

Test Arm

EXPERIMENTAL

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

Drug: ADT for 9 months and ARTA for 6 months

Standard Arm

ACTIVE COMPARATOR

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

Drug: ADT for 2 years

Interventions

ADT for 9 months and ARTA for 6 months DRUG

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

Test Arm

ADT for 2 years DRUG

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

Standard Arm

Eligibility Criteria

• Age: 19 Years - 99 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tata Memorial Centre: lead

Study Sites (1)

Tata Memorial Centre

Mumbai, Maharashtra, 400012, India

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Androgen Antagonists

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 10, 2025
• Study Start: February 17, 2025
• Primary Completion (Estimated): January 1, 2035
• Study Completion (Estimated): January 1, 2035
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)