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

Recruiting Phase 2 Interventional Study
Prostate Carcinoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
19 – 99
Sex
Male
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
206 (estimated)
Sponsor
Tata Memorial Centre · Other
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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 …
Trial Locations
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Eligibility Criteria
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 + * Patien…
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