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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 19
Maximum Age: 99
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
India
Tata Memorial Centre
RECRUITING
Mumbai
Time Frame
Start Date: 2025-02-17
Estimated Completion Date: 2035-01-01
Participants
Target number of participants: 206
Treatments
Experimental: Test Arm
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
Active_comparator: Standard Arm
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
Related Therapeutic Areas
Sponsors
Leads: Tata Memorial Centre

This content was sourced from clinicaltrials.gov

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