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

Reduced Length of ADT and ARTA With XRT in High-Risk Prostate Cancer (RELAX): A Randomised Trial (NCT06818682) is a Phase 2 interventional studying Prostate Carcinoma, sponsored by Tata Memorial Centre. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Prostate Carcinoma and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 206 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Prostate Carcinoma subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify:- - 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 - You should be able to carry out daily activities with 0 level of ability (ECOG 0)-2 - Patient able and willing for willing to sign a consent form and reliable for follow-up Who Should NOT Join This Trial:- - 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 Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DRUG

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

DRUG

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

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Tata Memorial Centre

Mumbai, Maharashtra, India

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06818682), the sponsor (Tata Memorial Centre), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06818682 clinical trial studying?

Who can participate in NCT06818682?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06818682?

Contact information for this trial may be available directly on the ClinicalTrials.gov record. Click "View on ClinicalTrials.gov" in the sidebar for the official source. Always discuss any potential trial with your doctor before contacting the study site.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06818682. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06818682. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.