Shorter hormone therapy combined with radiotherapy for high-risk prostate cancer
Reduced Length of ADT and ARTA With XRT in High-Risk Prostate Cancer (RELAX): A Randomised Trial
This study is testing if a shorter hormone therapy combined with radiotherapy can help men with high-risk prostate cancer do better and feel better than the usual two-year hormone treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 206 (estimated) |
| Ages | 19 Years to 99 Years |
| Sex | Male |
| Sponsor | Tata Memorial Centre Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Mumbai, Maharashtra) |
| Trial ID | NCT06818682 on ClinicalTrials.gov |
What this trial studies
This study aims to improve treatment outcomes for high-risk non-metastatic prostate cancer by comparing a reduced duration of hormone therapy to the standard two-year duration, alongside standard radiotherapy. The shorter hormone therapy will be intensified with newer agents like abiraterone or enzalutamide, which have shown promise in enhancing disease control. The study will evaluate cancer control, survival rates, and overall quality of life, while also assessing the side effects associated with each treatment regimen. This approach seeks to minimize the side effects of prolonged hormone therapy without compromising treatment efficacy.
Who should consider this trial
Good fit: Ideal candidates include patients with biopsy-proven high-risk prostate adenocarcinoma who are suitable for curative-intent radiotherapy.
Not a fit: Patients with primary Gleason pattern 5 or those with a life expectancy of less than two years may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and less burdensome treatment options for patients with high-risk prostate cancer.
How similar studies have performed: Other studies have shown success with similar approaches in reducing treatment duration while maintaining efficacy, suggesting potential for positive outcomes in this trial.
Eligibility criteria
Show full inclusion / exclusion 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 + * 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
Where this trial is running
Mumbai, Maharashtra
- Tata Memorial Centre — Mumbai, Maharashtra, India (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.