NCT06818682RecruitingPhase 2

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

Source: ClinicalTrials.gov · Last updated 21 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry): Recruiting
Phase (registry): Phase 2
Study type: Interventional
Enrollment: 206 (estimated)
First submitted: 7 Feb 2025
Start date: 17 Feb 2025
Primary completion date: 1 Jan 2035
Lead sponsor: Tata Memorial Centre
Diseases: Prostate cancer
NCT number: NCT06818682

What you commit to

Study type: Interventional · Phase 2
Planned participants: 206
From 17 Feb 2025 to the primary completion date, 1 Jan 2035
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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.)

Other illness

Uncontrolled comorbidities such as diabetes or hypertension causing ineligibility to receive ARTA
Bulky primary disease with extensive infiltration into bladder/rectum/pelvic muscle

Other

Primary Gleason pattern 5 (Gleason score 5+4 or 5+5)
Life expectancy deemed to be less than 2 years
Presence of adverse pathological variants (such as small cell histology)
Unable or unwilling to consent and follow up

Who the study is looking for

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

Age in the registry: 19 years to 99 years · Sex: Male · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Tata Memorial Centre Coordinator of this site? Confirm its status	Mumbai	India	Recruiting

Related publications

Reduced Length of ADT and ARTA With XRT in High-Risk Prostate Cancer (RELAX): A Randomised Controlled Trial.Clin Oncol (R Coll Radiol) · 2026 · PMID 42567090

This page is information, not medical advice. Discuss any trial with your doctor.