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

Study acronym: RELAX
StatusRecruiting
PhasePhase 2
Started2025-02-17
View on ClinicalTrials.gov ↗

Amendment history

2025-02-19
notable
Not Yet Recruiting→Recruiting Study Identification, Study Status, Oversight, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-02-10→confirmed 2025-02-17
Study sitesdetails revised at 1 of 1 site
Study titlerevised
Reduced Length of ADT and ARTA withWith XRT in High-Risk Prostate Cancer (RELAX): aA Randomised Trial
2025-02-10
minor
Study Status, Study Description, Conditions, Eligibility v1
Eligibility criteria-46 characters
Inclusion Criteria:- 1. Patients with biopsy proven prostate adenocarcinoma, deemed suitable for curative- intent radiotherapy 2. Clinicoradiological stage T1-T4N0M0 using PSMA-PETCT and MRI 3. High risk or very high risk (as per NCCN 2023): stage T3a + OR Gleason Score 4+4 or 4+5 OR PSA 20 + 4. Patient fit and able to receive ADT for 2 years 5. Patient fit and able to receive ARTA for 6 months 6. ECOG performance status 0-2 7. Patient able and willing for informed consent and reliable for follow-up Exclusion Criteria:- 1. Primary Gleason pattern 5 (Gleason score 5+4 or 5+5) 2. Life exp [...] [...]
2025-02-07
minor
Original filing
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.
Trial Details
NCT Number NCT06818682
Lead Sponsor Tata Memorial Centre
Conditions Prostate Carcinoma
Enrollment 206 participants
Start Date 2025-02-17
Primary Completion 2035-01-01 (estimated)
Study Completion 2035-01-01 (estimated)
Updated on ClinicalTrials.gov 2025-02-21